Reference Guide

®
Boehringer Mannheim Elecsys 2010 System

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V` 2.0

011642500-0398 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
 © 1998, Boehringer Mannheim. All rights reserved.
The contents of this manual, including all graphics and photographs are the
property of Boehringer Mannheim. Information in this document is subject to
change without notice. Boehringer Mannheim shall not be liable for technical or
editorial errors or omissions contained herein.
No part of this document may be reproduced or transmitted in any form or by any
means, electronic or mechanical, for any purpose, without the express written
permission of Boehringer Mannheim.
Elecsys is a registered trademark of Boehringer Mannheim GmbH.
CalCheck is a trademark of Boehringer Mannheim Corporation
Origen is a registered trademark of IGEN, Inc.

This manual was created by the Boehringer Mannheim Technical Publications

Department. Questions/comments regarding the content of this manual can be
directed to your local Boehringer Mannheim representative, or to:
Boehringer Mannheim Corporation
P.O. Box 50446
9115 Hague Road
Indianapolis, IN USA
46250-0446
Attention: Technical Publications Department

US Order Number: 011001401

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0

Revised Manual Pages
Revised pages for this manual are provided by Boehringer Mannheim when
necessary. No part of this publication may be reproduced in any form or by any
means without prior written permission.

Publication Date Pages Affected

Reference No.

Version 1.0 November 1996 Reference Guide

Software Guide
User’s Guide
Tutorial Guide

Version 2.0 March 1998 Reference Guide

Software Guide
User’s Guide
Tutorial Guide
Short Guide

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0

 Reference Guide
Table of Contents

Chapter 1 – Introduction
1.1 Introduction .................................................................................. 1-2
Introduction ......................................................................................................... 1-2
The Elecsys 2010 Immunoassay System ............................................................ 1-3

1.2 General Overview ......................................................................... 1-5

Introduction ......................................................................................................... 1-5
General................................................................................................................ 1-5
Warranty .............................................................................................................. 1-5
Using the Operator’s Manual .............................................................................. 1-6
Manual Set-up .................................................................................................... 1-6
Manual Revisions ................................................................................................ 1-6
Analyzer Installation ............................................................................................ 1-7
Service ................................................................................................................ 1-7
Customer Training ............................................................................................... 1-7
Test Specific Information..................................................................................... 1-7
Ordering Information ........................................................................................... 1-7

1.3 Product Labeling .......................................................................... 1-8

Introduction ......................................................................................................... 1-8
Reagent Kits (Reagent Packs) ............................................................................. 1-9
Reagent Kit Box Labels ....................................................................................... 1-9
Reagent Bar Code Label ................................................................................... 1-10
Calibrator and Control Kits................................................................................ 1-11
Calibrator and Control Bar Code Cards ............................................................ 1-12
Calibrator and Control Bar Code Labels ........................................................... 1-12
Package Insert .................................................................................................. 1-13
Product Information Sheet ................................................................................ 1-13

1.4 Potential Hazards and Safety Precautions .............................. 1-14

Introduction ....................................................................................................... 1-14
Visual Cues ....................................................................................................... 1-15
Warning Stickers ............................................................................................... 1-15
Potential Hazards and Safety Precautions ........................................................ 1-16
Additional Precautions ...................................................................................... 1-17

1.5 Approvals and Declaration of Conformity ............................... 1-20

Approvals .......................................................................................................... 1-20
EC Declaration of Conformity ........................................................................... 1-21

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 i

Reference Guide – Table of Contents

Chapter 2 – System Description

2.1 System Description ..................................................................... 2-2
Introduction ......................................................................................................... 2-2
The Control Unit .................................................................................................. 2-2
The Analyzer Unit ................................................................................................ 2-3
Sample/Reagent Area ......................................................................................... 2-4
Consumables Area .............................................................................................. 2-4
Measuring Area ................................................................................................... 2-4
Power Switch ...................................................................................................... 2-4

2.2 Control Unit Components ........................................................... 2-5

Introduction ......................................................................................................... 2-5
Touchscreen Monitor .......................................................................................... 2-5
Keyboard ............................................................................................................. 2-5
Floppy Disk Drive ................................................................................................ 2-6
Data Disk ............................................................................................................. 2-6
External Printer .................................................................................................... 2-7
Host Interface ...................................................................................................... 2-7

2.3 Sample/Reagent Area Components .......................................... 2-8

Introduction ......................................................................................................... 2-8
Sample Disk ........................................................................................................ 2-8
Rack Sampler ...................................................................................................... 2-9
Sample/Reagent (S/R) Probe ............................................................................ 2-13
Bar Code Reader .............................................................................................. 2-14
Bar Code Card Reading Station ........................................................................ 2-15
Reagent Disk ..................................................................................................... 2-15
Reagent Cap Open/Close Mechanism .............................................................. 2-16
Microparticle Mixer ........................................................................................... 2-16
Probe/Mixer Rinse Station ................................................................................ 2-17
Sample/Reagent (S/R) Pipettor ......................................................................... 2-17

2.4 Consumables Area Components ............................................. 2-18

Introduction ....................................................................................................... 2-18
Gripper .............................................................................................................. 2-18
Cup Disposal Opening ...................................................................................... 2-19
Pipetting Station................................................................................................ 2-19
Distilled Water Container ................................................................................... 2-20
Liquid Waste Container ..................................................................................... 2-20
Solid Waste Tray and Liner ................................................................................ 2-21

ii Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0

 Reference Guide – Table of Contents

2.5 Measuring Area Components ................................................... 2-22

Introduction ....................................................................................................... 2-22
Incubator ........................................................................................................... 2-22
Sipper Probe ..................................................................................................... 2-23
Sipper Pipettor .................................................................................................. 2-23
System Reagents (ProCell and CleanCell) ........................................................ 2-24
Detection Unit ................................................................................................... 2-25

2.6 Power Components ................................................................... 2-26

Operation ON/OFF Switch ................................................................................ 2-26
Circuit Breaker .................................................................................................. 2-26
Rack Circuit Breaker ......................................................................................... 2-26

2.7 Technical Data ............................................................................ 2-27

Instrument Dimensions ..................................................................................... 2-27
Electrical ........................................................................................................... 2-27
Environmental Conditions ................................................................................. 2-28
Noise Level (DIN 43635) .................................................................................... 2-28
Water Supply ..................................................................................................... 2-28
Liquid Waste ..................................................................................................... 2-28
Throughput Rate ............................................................................................... 2-28
Sampling System .............................................................................................. 2-28
Reagent System ................................................................................................ 2-30
Incubation System ............................................................................................ 2-30
Measuring System ............................................................................................ 2-31
Control System ................................................................................................. 2-31

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 iii
Reference Guide – Table of Contents

Chapter 3 – Mechanical Theory

3.1 Functional Sequence of Analysis ............................................... 3-2
Introduction ......................................................................................................... 3-2
Test Protocols ..................................................................................................... 3-2
General Assay Sequence .................................................................................... 3-2
Operation Flow In Analysis .................................................................................. 3-5

3.2 Detailed Assay Sequence ........................................................... 3-6

Introduction ......................................................................................................... 3-6
Preoperation Steps ............................................................................................. 3-6
Dispense Reagent 1, Reagent 2 and Sample (Disk system) ............................... 3-7
Dispense Reagent 1, Reagent 2 and Sample (Rack system) .............................. 3-9
First Incubation ................................................................................................. 3-11
Microparticle Preparation .................................................................................. 3-11
Microparticle Aspiration and Dispense ............................................................. 3-12
Second Incubation ............................................................................................ 3-12
Measurement Process Preparations ................................................................. 3-13
Measurement Process ...................................................................................... 3-13
Signal Detection and Conversion ...................................................................... 3-14
Automatic Analyzer Cycles ............................................................................... 3-14

3.3 Dilution Steps ............................................................................. 3-15

Dilution Steps .................................................................................................... 3-15
Pretreatment Steps ........................................................................................... 3-16

3.4 Analyzer Status Conditions....................................................... 3-17

Introduction ....................................................................................................... 3-17

Chapter 4 – ECL Technology

4.1 ECL Technology ........................................................................... 4-2
Introduction ......................................................................................................... 4-2
ECL Assay Principles .......................................................................................... 4-2
Use of the Ruthenium Complex .......................................................................... 4-3
The ECL Reaction at the Electrode Surface ........................................................ 4-4
ECL Signal Generation ........................................................................................ 4-6
ECL Measuring Cell ............................................................................................ 4-7
Advantages of ECL Technology .......................................................................... 4-8

iv Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0

 Reference Guide – Table of Contents

Chapter 5 – Test Principles

5.1 Competitive Test Principle .......................................................... 5-2
Introduction ......................................................................................................... 5-2
Competitive Principle .......................................................................................... 5-2

5.2 Sandwich Test Principle .............................................................. 5-4

Sandwich Principle ............................................................................................. 5-4

5.3 Bridging Test Principle ................................................................ 5-6

Bridging Principle ................................................................................................ 5-6

Chapter 6 – Calibration
6.1 Reagent Calibration ..................................................................... 6-2
Introduction ......................................................................................................... 6-2
Master Calibration ............................................................................................... 6-3
Lot Calibration ..................................................................................................... 6-4
Reagent Pack Calibration ................................................................................... 6-4
Calibration Stability ............................................................................................. 6-4
Calibration Validation .......................................................................................... 6-5
Calibration Quality Criteria .................................................................................. 6-6

6.2 Calibration of Quantitative Assays ............................................. 6-7

Introduction ......................................................................................................... 6-7
Rodbard Function ............................................................................................... 6-7
Linear Calibration Function ................................................................................. 6-8
Linear Reciprocal Calibration Function ............................................................... 6-8

6.3 Calibration of Qualitative Assays ............................................... 6-9

Calibration of Qualitative Assays ........................................................................ 6-9
Result Calculation for Qualitative Assays .......................................................... 6-10

Glossary ............................................................................................... G-1

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 v

 Notes

vi Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0

Chapter 1
Introduction

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 1-1
1.1 Introduction

Introduction
The Reference Guide is part of the total documentation for the Boehringer
Mannheim Elecsys ® 2010 Immunoassay System, additionally consisting of the
Software Guide, User’s Guide, Tutorial Guide and the Short Guide.
The Reference Guide gives a comprehensive overview of the Elecsys 2010
Immunoassay Analyzer. Furthermore, this guide gives background information on
all system-specific topics that are not necessarily part of the daily routine, but give
valuable information on the function of the entire system.
The Reference Guide covers all topics relating to the functionality of the
instrument and the technical data. In addition, it contains descriptions of the
measuring methods on which the tests are based.
The Reference Guide also describes in detail the safety precautions that must be
heeded while working with the 2010 system.

1-2 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
 1.1 Introduction

The Elecsys 2010 Immunoassay System

The Boehringer Mannheim Elecsys 2010 Immunoassay System is a fully
automated, random access, software-controlled system for immunoassay
analysis. It is available as both a disk system and a rack system. The differences
between the two configurations are detailed throughout this operator’s manual.

Elecsys 2010 disk system

Elecsys 2010 rack system

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 1-3
1.1 Introduction
The Elecsys 2010 was designed for both quantitative and qualitative in vitro
determinations using a wide variety of tests. Both disk and rack systems have a
throughput per hour of approximately 86 tests.
The Elecsys 2010 analyzer can be placed on a bench top, thus saving space in the
laboratory environment. Handling of the system is easy; potential for manual
errors is reduced to a minimum. All assay reagent, calibrator and control
information is automatically entered into the software by bar codes.
The system consists of the analyzer, which performs all functions required for fully
automated sample and assay processing, and a control unit, which controls the
analyzer through the user software. This entirely automated process begins with
the recording of patient samples - provided that they are in bar code-labeled
tubes - up to the electrochemiluminescent detection and results transmission.
Data transmission to and from the analyzer, results evaluation, documentation,
and quality control are performed automatically by the software. Furthermore, the
software is responsible for the management of data between a connected
laboratory information system (LIS) and the 2010. Several Elecsys analyzers can
be centrally controlled when integrated with the Laboratory System Manager
(LSM) designed by Boehringer Mannheim.
An outstanding feature of the analyzer system is the touchscreen and easy to use
software. The advantages of the system include:
• Easy operation via touchscreen, very few manual entries required.
• Integrated bar code concept improves convenience and workflow. Manual
entry of individual sample identifications is not required, if bar code-labeled
tubes are used. Sample racks (on the rack system), reagent packs,
calibrator and control vials (also bar code-labeled) are also read
automatically.
• Automatic entry of test applications. Transfer of test parameters to the
system via the reagent bar code label speeds installation of new assays.
• Real time monitoring of the analyzer allows the system to run unattended.
The operator is immediately notified of any problems.
• Continuous access to samples avoids interruptions of the routine testing
while ensuring that results will be available as quickly as possible.
• STAT samples are prioritized and processed first.
• Reagents are kept at a constant temperature (20 ± 3 °C) on the analyzer,
allowing on analyzer storage.

1-4 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
 1.2 General Overview

Introduction
The Boehringer Mannheim Elecsys® 2010 Immunoassay System is an automated,
random access, multichannel analyzer for immunological tests, intended for in
vitro quantitative or qualitative determination of a wide range of analytes. The
analyzer is specially designed for performing assays utilizing
electrochemiluminescent (ECL) technology and is marketed by Boehringer
Mannheim.
Packaged with your analyzer, you will receive an:
• accessory kit
• installation kit.
After your instrument is installed, the following consumable materials should be
ordered as necessary from Boehringer Mannheim:
• reagents • assay cups
• calibrator sets • assay tips
• CalCheck™ kits (USA only) • CalSet Vials (empty calibrator/
• Elecsys ProCell control vials)
• Elecsys CleanCell • Clean-Liners
• Elecsys BlankCell • printer paper
• control material • printer ribbon.

General
This operator’s manual is intended to be used as an instructional aid in the
performance of tasks related to the operation and general maintenance of the
instrument. The manual contains detailed descriptions of instrument features and
general operational concepts, specifications, theory of operation, function and use
of controls, operating techniques, emergency procedures, product labeling and
maintenance procedures.

Warranty
For warranty conditions, refer to the analyzer purchase agreement. Contact your
local Boehringer Mannheim representative for further information.

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 1-5
1.2 General Overview

Using the Operator’s Manual

The arrangement of this manual is planned for a sequential, progressive,
programmed style of study. Anyone attempting to operate the instrument should
not do so until thoroughly familiar with the information in this manual. The key to
good performance is good preparation by thoroughly studying the information
contained in this manual.
The manual is divided into the following four guides:
• Reference Guide: This book provides general information about Boehringer
Mannheim (e.g., ordering reagents and contacting technical support), an
introduction to the analyzer, instrument specifications, precautions and
warnings, mechanical and chemistry methodology theory.
• Software Guide: This book describes in detail the software on the analyzer.
A basic organization and navigation, as well as detailed menu/screen
displays are provided. Reports available from the analyzer are also found in
this book.
• User’s Guide: This book contains general troubleshooting, data and
instrument alarms, maintenance and a spare parts list.
• Tutorial Guide: This book provides a basic overview of the system, daily
operational procedures and a “How to...” section (i.e., instructions on most
tasks the average operator is required to perform).
Also included with the manual is the Short Guide. This small document is
designed to complement your operator’s manual. The Short Guide tells you
exactly what is necessary to operate the analyzer, without the level of detail found
in the Tutorial Guide. Please refer to the Tutorial Guide of your operator’s manual
for additional operational details.

Manual Set-up
The general table of contents at the beginning of each guide and the subject index
located in the back of the guide, provide points of quick correlation for cross
referencing. Pictorials are repeated as necessary to minimize page flipping and
references are made between sections to point out specific guide information.

Manual Revisions
The arrangement of the manual facilitates easy updating and revision. Page
revision packages are issued from time to time for user insertion into the manual.
Instructions accompany each revision package.

1-6 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
 1.2 General Overview

Analyzer Installation
Installation is performed by a Boehringer Mannheim representative. The customer
is responsible for providing the necessary facilities as detailed in Section 2.7,
Technical Data.

Service
Contact your local Boehringer Mannheim representative for further information
regarding the Elecsys 2010 analyzer service agreement.

Customer Training
Contact your local Boehringer Mannheim representative for questions regarding
Elecsys 2010 analyzer training.

Test Specific Information

Information specific to a particular chemistry test can be found in the chemistry
package insert and/or product information for that method. Chemistry product
informations are located in your product information binder.

Ordering Information
Replacement parts, consumable materials, reagents, calibrators and controls
should be ordered as necessary from Boehringer Mannheim. When ordering,
please use the Boehringer Mannheim catalog number and reference name for
each item.

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 1-7
1.3 Product Labeling

Introduction
Elecsys reagent packs have a special 2D (two dimensional) bar code. This allows
fully automatic registration and management of reagent information. Manual entry
or additional monitoring is not necessary. The ready-to-use, liquid reagents are
loaded into one of the 18 positions on the reagent disk. Reagents are available for
analysis after their bar codes are scanned.

Calibrators

The handling of calibrators and Boehringer Mannheim controls corresponds to

that of reagents. Most calibrators are ready to use. Lyophilized controls and
some calibrators must be prepared and transferred into the appropriate container.
For quantitative assays, calibrator and control information is stored on 2D bar
code cards (refer to subsection, Calibrator and Control Bar Code Cards). For
qualitative assays, all information necessary for calibration is encoded on the bar-
coded bottle labels contained in the kit.

1-8 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
 1.3 Product Labeling

Reagent Kits (Reagents Packs)

The photo shows an example of the reagent
pack used on the Elecsys 2010 analyzer. Each
reagent pack is a ready to use single unit.
A reagent pack consists of three bottles:
• a white bottle with a white or
transparent lid containing the
suspended paramagnetic
microparticles, that act as the carrier
material of the ruthenium-labeled
complex during measurement
• a black bottle with a gray lid
containing R1
• a black bottle with a black lid
containing R2.
The reagent pack and reagent disk are keyed Elecsys reagent pack
so reagents cannot be placed incorrectly on the analyzer.

Reagent Kit Box Labels

The following are examples of typical box labels for an Elecsys reagent kit. The
large label contains the intended use statement, storage temperature, contents
and catalog number of the kit. The smaller side box label contains the lot and
expiration date of the kit as well as a bar code number. This bar code number is
used for tracking purposes and is not used by the analyzer.

Elecsys®
T4
For the determination Store at/Lagern bei/Conservation/ Catalog number
of thyroxine Conservar/Conservare a: 2 - 8°C
Zur Bestimmung von Contents/Inhalt/Contenu/Contenido/
Thyroxin Componenti: T4 Elecsys
Pour le dosage de la M R1 R2 for/für/pour 200 Tests 1778323
122

thyroxine M : 12 ml, cont./enth.: Streptavidin(e)-

Para la determinacion Micropartic(u)les 0.72 mg/ml
015630 899630

de la tiroxina R1: 18 ml, cont./enth.:

Per la determinazione T4~Biotin(e) 10 ng/ml; ANS 1 mg/ml
della tiroxina R2;18 ml, cont./enth.:
Exp./Verw.bis: Dec 97

2+
anti-T4~AB/AK/AC~Ru(bpy)3
Lot/Ch.-B: 123456

(Sheep/Schaf/mouton/oveja/pecora,
polyclon.) 150 ng/ml

1778323 IN VITRO DIAGNOSTICUM

1720643(1)

01
4

Boehringer Mannheim GmbH, Mannheim, Germany

Boehringer Mannheim Corp., Indianapolis, IN U.S.A 03

Kit lot number

Elecsys reagent box labels (actual size)

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 1-9
1.3 Product Labeling

Reagent Bar Code Label

Reagent packs have a bar code label that T3
contains information required to run the assay Elecsys®
on the analyzer. This information includes, but
is not limited to: å 1731360
M 12 ml
• test number R1 16 ml
• lot number R2 16 ml
• master calibration curve parameters
(e.g., rodbard parameters)
ç123472 IN VITRO
• instrument settings
é
DIAGNOSTICUM

• calibrator lot numbers and assigned

530312511302720
Boehringer
values Mannheim
• expiration date GmbH
• calibration frequency. 2 - 8°C

è
Lot/Ch.-B:
The following information can be identified on 448866 04
Exp./Verw.bis
each reagent bar code label:
å kit catalog number
ê Aug 96

ç reagent pack number

é reagent bar code number T3 reagent bar code label
è kit lot number (actual size)
ê expiration date.
Additional information on the reagent pack number and reagent bar code number
can be found in Section 2.2, ‘Reagent Details’ Pop-up Window – Software Guide.
The reagent bar code labels are in a unique format. The symbology utilizes
portable data files (PDF) and is called PDF417. Traditional linear bar codes serve
as a link to a database that contains the appropriate information. PDF417 is a
two-dimensional, stacked bar code that contains an entire data record. The large
amount of data that can be encoded allows all instrument settings to be included,
as well as the master calibration curve and additional information for the assay. It
is from this master calibration curve and from the operator 2-point calibration that
the analyzer derives the update of the master calibration curve. For further
information, refer to Chapter 6, Calibration.
“Every PDF417 symbol (bar code) contains two error detection codewords that are
used like the check digit in linear bar code symbologies to detect decode errors
and verify that all data have been read and decoded accurately. Additionally,
PDF417 provides error correction in the event that portions of the symbol have
been damaged, destroyed or are unreadable.” 1

1. Itkin S, Martell J. A PDF417 Primer: A Guide to Understanding Second Generation Bar

Codes and Portable Data Files. Bohemia, NY: Symbol Technologies, Inc; 1992:17-18.

1-10 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
 1.3 Product Labeling
It is a combination of this error detection and error correction that ensures a
reliable bar code. There should only be exceptional cases when bar codes are
damaged enough that they cannot be read by the analyzer. If the bar code cannot
be read and the reagent lot has been previously used by the analyzer, the 15-digit
number found on the reagent bar code label can be manually entered into the
software.

Calibrator and Control Kits

Calibrators and controls for the Elecsys
reagents come packaged separately
(e.g., Elecsys Troponin-T CalSet or
Elecsys PreciControl Universal). Each
kit contains either bar-coded calibrator
or bar-coded control vials ready for use
on the analyzer. Most calibrators are in
a ready to use liquid form and require
no further action other than to place
them on the sample disk or rack when
a calibration is necessary. PreciControl Universal kit
A few of the calibrators and the controls are lyophilized in glass bottles and must
be reconstituted before being transferred into plastic bar code-labeled vials.
(Empty bar code-labeled vials are packaged in these kits with lyophilized
calibrators or controls.) Reconstituted calibrators and controls can be stored in
the plastic vials after transfer.
Calibrators and controls also have color-coded caps to assist you in identification.
A white cap is a level one calibrator/control and a black cap is a level two
calibrator/control.
A calibrator or control bar code card comes packed in each calibrator or control
kit, respectively. These cards are described in more detail on the next pages.

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 1-11
1.3 Product Labeling

Calibrator and Control Bar Code Cards

Each calibrator and control kit comes with a bar
code card. These cards are also in the PDF417
format and must be used in conjunction with the
corresponding controls and calibrators.
Information encoded in the calibrator/control bar
code cards includes, but is not limited to:
• test number
• calibrator/control lot number
• control code (e.g., PC U1) (control card
only)
• lot identifier to calibrator/control bar
code labels
• what calibrators are to be used and their
number of determinations (calibrator
card only) PreciControl bar code card
• target or assigned values
• control ranges (control card only)
• expiration date.
Boehringer Mannheim produces a factory master calibration for each calibration
lot. The results are encoded into the corresponding reagent bar code. Scan the
new bar code card when a new lot of calibrator or control is used.

Calibrator and Control Bar Code Labels

Each calibrator and control bottle has a
traditional linear bar code label that contains an
identifier to link it to information encoded in the
reagent bar code label and the calibrator or
control bar code card.

Calibrator bottle bar code labels

1-12 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
 1.3 Product Labeling

Package Insert
Each reagent kit comes with a package insert. This insert contains information
required to perform the assay. Detailed information is contained in the product
information sheet supplied separately.

Product Information Sheet

Each assay applied to this analyzer has a product information sheet that provides
general information about the assay. Data contained in the product information
sheet is more detailed than what is in the package insert. Instrument settings are
encoded in reagent bar codes and not entered by the operator. This type of
information, such as sample volume, reagent volume, etc. is found in the Overview
section of the product information sheet.

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 1-13
1.4 Potential Hazards and Safety Precautions

Introduction
Before you start working with the analyzer, acquaint yourself with all safety
precautions and regulations concerning handling of materials and the system’s
electrical and mechanical components.

Chemical
The operator is responsible for taking all necessary precautions against hazards
associated with the use of clinical laboratory chemicals. Specific recommendations
for each reagent used on the analyzer are found on the box label, package insert or
product information sheet for each chemistry. Material Safety Data Sheets (MSDS)
are available for Boehringer Mannheim reagents.
Immediately remove any reagent spillage from the instrument.

Electrical
DO NOT attempt to open the instrument covers and work in any electronic
compartment. An electrical shock may occur.

Mechanical
As with any mechanical system, there are certain precautions to take when
operating the instrument. DO NOT wear loose garments or jewelry that could
catch in moving mechanisms. DO NOT put your hands into the pathway of any
moving parts while the analyzer is operating. Particular areas to avoid are the A-
Line (rack system), B-Line (rack system), C-Line (rack system), sample/reagent
probe, gripper (tip/cup carrier) and the sipper probe. Operate the instrument with
the covers down unless you place additional samples on the sample disk or A-
Line, or remove samples from the sample disk or C-Line. DO NOT attempt
mechanical repair unless the instrument is in Stand-by or OFF.

Biohazardous Materials
As with all in vitro diagnostic equipment, patient samples and serum-based quality
control (QC) products that are assayed on this system, as well as all waste from
the waste containers, should be treated as potentially biohazardous. All materials
and mechanical components associated with the sampling and waste systems
should be handled according to your facility’s biohazard procedure. Use the
personal protective equipment recommended by your facility when handling any
of these components.

1-14 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
 1.4 Potential Hazards and Safety Precautions

Visual Cues
Throughout this manual, three icons are used to draw attention to certain
information. These are listed below.

n
Notes contain information about a topic in the text.

c
Caution messages contain information which, if not observed, could result in
loss of data or in damage to the analyzer.

$
Warning messages contain information which, if not followed, could cause
serious personal injury and/or damage to the analyzer.

Warning Stickers
There are three different stickers that appear on the 2010 analyzer. These stickers
are also used to draw your attention to certain conditions. The stickers are listed
below.
! WARNING This sticker warns you that there are mechanisms in
! AVERTISSEMENT action within the vicinity of this sticker. In addition, these
mechanisms are in contact with potential biohazards.
Keep your hands out of this area while the analyzer is in
operation.

! WARNING This sticker warns you that there are potential biohazards
! AVERTISSEMENT
within the vicinity of this sticker. Take the necessary
precautions and handle all material in this area as
potentially infectious.

! WARNING This sticker warns you that there are corrosive or caustic
! AVERTISSEMENT
reagents within the vicinity of this sticker. Take the
necessary precautions and handle the reagents with
care.

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 1-15
1.4 Potential Hazards and Safety Precautions

Potential Hazards and Safety Precautions

Mechanisms in Action
! WARNING 1. Verify that all analyzer lids are closed during operation.
! AVERTISSEMENT 2. Avoid touching the A-, B-, or C-Lines, sample/reagent probe
mechanism, sipper probe mechanism, gripper (tip/cup carrier)
mechanism, mixing mechanism and other moving parts while
the instrument is operating. Otherwise, personal injury may
result.
3. Verify sampling has stopped when you load additional
samples on the sample disk or remove processed samples
from the sample disk while the analyzer is in operation. Or,
verify there is no rack movement (i.e., rack indication light is
green) when you load additional sample racks on the A-Line
or remove processed sample racks from the C-Line while the
analyzer is in operation. Otherwise, personal injury may
result.

Samples
! WARNING 1. Treat all samples as potential biohazards. If sample spills on
! AVERTISSEMENT the instrument, utilize correct personal protective equipment
(PPE-gloves, lab coat, etc.) and wipe it off immediately.
2. Make sure that the sample does not contain any fibrin, dust or
other insoluble contaminants. If insoluble contaminants are
contained in the sample, correct measuring values may not be
obtained.

Waste Solution and Solid Wastes

! WARNING 1. Avoid direct contact with waste solution and/or solid wastes.
! AVERTISSEMENT Both should be handled as potential biohazards.
2. Dispose of waste solution and/or solid wastes according to
the relevant governmental regulations.
3. Consult the reagent manufacturer for information on the
concentrations of heavy metals and other toxic constituents in
each reagent.
4. Do not add bleach to the liquid waste container. Bleach
combined with the contents of the liquid waste could cause
potentially harmful fumes.

1-16 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
 1.4 Potential Hazards and Safety Precautions
Biohazardous parts
! WARNING 1. Avoid direct contact with the sample/reagent probe, sipper
! AVERTISSEMENT probe and rinse stations. Treat as potentially biohazardous
areas.
2. Verify sampling has stopped before you load additional
samples on the sample disk or remove processed samples
from the sample disk while the analyzer is in operation.
Otherwise, you may touch the potentially biohazardous
sample/reagent probe.

Reagents
! WARNING 1. Avoid direct contact with reagents. Direct contact may result
! AVERTISSEMENT in skin irritation or damage. Refer to the reagent kit box labels
for specific instructions.
2. Avoid direct contact with CleanCell. Direct contact may result
in skin irritation or damage. Refer to the CleanCell box label
for specific instructions.

Additional Precautions

$
To Prevent Electrical Shock
1. Do not open the back cover. You may receive an electric
shock.
2. Do not open the cover of the PMT high voltage supply circuit
board with the power switch or circuit breaker turned on.
Touching the board may cause death or severe injury.

$
Flammables
Avoid using dangerous flammables around the instrument. Fire
or explosion may be caused by ignition.

Accuracy/Precision of Measured Results

For proper use of the instrument, measure control samples and
monitor the instrument during operation.
An incorrectly measured result may lead to an error in diagnosis,
therefore posing danger to the patient.

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 1-17
1.4 Potential Hazards and Safety Precautions
Application
The instrument is designed for clinical immunological test
analysis using water-soluble samples and reagents.
Please note that other analyses may not be applicable to this
instrument.
Operator Qualification
1. Operation should be conducted under the management of a
technician who has undergone training at the facility specified
by the sales agent.
2. For clinical tests, the instrument should be used under the
management of a doctor or clinical inspector.

$
Operation and Maintenance
1. During operation and maintenance of the instrument, proceed
according to the instructions and do not touch any parts of
the instrument other than those specified.
2. Verify the front covers are closed while the instrument is in
operation unless you load samples on the sample disk or A-
Line or remove samples from the sample disk or C-Line.
3. Avoid touching the sample/reagent probe mechanism, sipper
probe mechanism, gripper (tip/cup carrier) mechanism, mixing
mechanism and other moving parts while the instrument is
operating. Otherwise, the instrument may be damaged or
operation may be stopped.
4. Avoid touching the sample disk or reagent disk while the
instrument is in operation. Otherwise, the instrument may be
damaged or operation may be stopped.
5. Do not use a cellular phone or a transceiver in the laboratory
because it may interfere with the analyzer.

Installation Requirements
Installation is performed by a Boehringer Mannheim
representative. The customer is responsible for providing the
necessary facilities as detailed in Section 2.7, Technical Data.

1-18 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
 1.4 Potential Hazards and Safety Precautions
Restrictions on Samples and Reagent Solutions
1. The assay cups, assay tips, detection unit and liquid waste
container or solid waste tray and liner are not guaranteed to
be chemically resistant against organic solvents. Therefore,
do not use organic solvents on these parts.
2. Avoid using sample and reagent solutions that are likely to
adhere to the assay tips, assay cups, liquid waste container
or detection unit.

Handling Reagent Solutions

Follow the manufacturer’s instructions for use of a reagent
solution.

Loading Samples and Reagents

Be sure to load samples and reagents only into the specified
positions on the instrument.
If sample or reagent is spilled, this may cause a malfunction of
the instrument.

c
Sample Disk
Verify sampling has stopped before you load additional samples
on the sample disk or remove processed samples from the
sample disk while the analyzer is in operation. Otherwise, the
instrument may be damaged or operation may be stopped.

c
A-Line (rack system)
Verify that the light on the rack sampler is green, prior to adding a
new rack or tray to the A-Line or removing a tray of processed
samples from the C-Line while the analyzer is in operation.
Otherwise, the instrument may be damaged or operation may be
stopped.

c
Microparticle Mixer
Be careful not to bend the microparticle mixer. A bent mixer
could lead to inaccurate results.

c
Switching On the Instrument
Never turn on the power within one second after turning it off.

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 1-19
1.4 Potential Hazards and Safety Precautions
Instrument Unused for a Long Time
If the instrument will not be used for a long period of time
(i.e., > 7 days), contact Customer Technical Support. Different
shutdown procedures are recommended depending upon the
duration of inactivity. In addition, certain procedures require the
assistance of a Boehringer Mannheim service representative.

Reagent Disk
Verify the reagent disk cover is locked on the reagent disk unless
you are exchanging reagents.

1-20 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
 1.5 Approvals and Declaration of Conformity

Approvals
The Elecsys 2010 analyzer was manufactured according to International
Electrotechnical Commission (IEC) 1010-1 “safety requirements for electrical
equipment for measurement, control and laboratory use.” This guideline is
equivalent to Underwriters Laboratories (UL) document 3101. These approval
marks appear on a single label on the right side of the analyzer.
The analyzer was tested and approved by the VDE and UL and received the
following safety marks:

issued by VDE Testing and Certification Institute,

DVE ¨
geprufte
Association of German Electrical Engineers (VDE)
Sicherheit

issued by Underwriters Laboratories, Inc. (UL)

UL®

issued by Underwriters Laboratories, Inc. for Canada

UL ®
as a Certification and Testing Organization by the
Standards Council of Canada (SCC).
C
the analyzer complies with all relevant European Union
(EU) directives.

Boehringer Mannheim GmbH confirms compliance with the currently valid

guidelines of the following declaration of conformity.

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 1-21
1.5 Approvals and Declaration of Conformity

EC Declaration of Conformity

1-22 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
Chapter 2
System Description

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 2-1
2.1 System Description

Introduction
The Boehringer Mannheim Elecsys 2010 Immunoassay System is a fully
automated, software-controlled system for immunoassay analysis. It was
designed for both quantitative and qualitative in vitro determinations using a large
variety of tests for analysis.
To assist you in quickly identifying which component is specific to either the disk
or rack system, one of the following graphics appears in the to the right of the
subsection header. If no graphic appears next to the header, then that component
is common to both systems.

Disk Rack

The Control Unit

The control unit, consisting of a touchscreen
monitor and a keyboard, is located on the
left of the analyzer. Also included as part
of the control unit is the floppy disk drive,
located inside the door above the solid
waste tray.
The touchscreen and keyboard can also
be removed from the shelf on the analyzer
and placed on the laboratory bench top.

Control unit

2-2 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
 2.1 System Description

The Analyzer Unit

Measuring area

Sample/Reagent area

Consumables area

Power switch

The analyzer unit on the disk system consists of the:

• sample/reagent area
• consumables area
• measuring area
• power switch.
The only difference on the rack system is in the sample area. The sample disk is
replaced by a rack sampling unit. Refer to the photo below.

C-Line

B-Line

A-Line
STAT position

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 2-3
2.1 System Description

Sample/Reagent Area
The sample/reagent area comprises the left half of the analyzer and consists of a
sample disk or rack sampler (rack system), rack bar code reader (rack system),
sample/reagent (S/R) probe, bar code reader, bar code card reading station,
reagent disk, a cap open/close mechanism, a microparticle mixer, probe/mixer
rinse station and sample/reagent (S/R) pipettor.
The sample disk accommodates up to 30 samples. The A-Line of the rack
sampler accommodates 75 samples on a single tray (15 racks at a time; each rack
with five positions) and 25 samples in the input buffer for a total capacity of 100
samples. The reagent disk, temperature controlled at 20 ± 3 °C, accommodates
up to 18 reagent packs.

Consumables Area
The consumables area is on the right of the analyzer, consisting of three tip trays,
three assay cup trays, a gripper unit, cup disposal opening, liquid waste container,
solid waste tray and liner and distilled water container.

Measuring Area
The measuring area includes the incubator, the sipper probe, sipper rinse station,
system reagents (ProCell and CleanCell), an aspiration station, sipper pipettor and
the detection unit. The sipper probe aspirates the incubated reaction mixture into
the detection unit for result determination.

Power Switch
The operation ON/OFF switch is located on the front left of the analyzer. In addition,
there is a circuit breaker for the analyzer located on the right rear of the analyzer and
a rack sampler circuit breaker located on the left side of the rack sampler.

2-4 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
 2.2 Control Unit Components

Introduction
The control unit consists of a color touchscreen monitor, a keyboard, floppy disk
drive unit and an external printer.

Touchscreen Monitor
The touchscreen monitor is located on
the left of the analyzer and displays the
software. The Elecsys 2010 software
displays menu items as folders. Each
folder is accessed by touching the
corresponding folder tab.

Touchscreen monitor

Keyboard

Navigation keys

Numeric keys
Global action keys

Keyboard

The 2010 keyboard consists of global action keys, navigation keys and numeric
keys. These keys are described in detail in the Section 1.1, Software Basics –
Software Guide.

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 2-5
2.2 Control Unit Components

Floppy Disk Drive

The floppy disk drive is located behind the
front access door above the solid waste
tray. The drive holds a data disk required
for analyzer operation.

Floppy disk drive

Data Disk
The data disk contains a number of files necessary for the analyzer and the
software to work together. These files include:
• assay reference tables: these tables contain information that is linked to
data encoded in the reagent bar code (e.g., test number, test code,
available units and unit conversion factors).
• calibration data
• result messages
• total number of determinations per reagent pack (i.e., 100 or 200)
• orders and test results (up to 400 can be stored)
• all instrument adjustments.

c
It is important to keep each data disk with its analyzer. Using a data disk
containing adjustments from a different analyzer results in mechanical
movement errors.

2-6 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
 2.2 Control Unit Components

External Printer
The instrument uses an 80-column,
graphics-capable, dot matrix printer.
Patient results can be printed in single or
multiple report format, which uses less
paper. Examples of each printed report
are found in Chapter 7 of the Software
Guide.
The printer is connected to the analyzer Location of the printer port
via a parallel printer port. The port is
located on the left side of the analyzer directly below the touchscreen cable port.

Host Interface
The instrument can be bidirectionally interfaced with a host computer. Details
concerning the interfacing of the 2010 analyzer are available by contacting
Customer Technical Support.

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 2-7
2.3 Sample/Reagent Area Components

Introduction
The sample/reagent area consists of a sample disk or rack sampler (rack system),
rack ID bar code reader (rack system), sample/reagent (S/R) probe, bar code
reader, bar code card reading station, reagent disk, cap open/close mechanism,
microparticle mixer, probe/mixer rinse station and sample/reagent (S/R) pipettor.

Sample Disk
The sample disk has 30 positions for
samples, calibrators and controls. Patient
samples may be placed in either primary
sample tubes or sample cups. Built-in
adapters allow intermixing of different
size primary sample tubes. The following
is a list of the available primary sample
tubes that may be used on the sample disk:
• 13 x 75 mm • 15.65 x 100 mm
• 13 x 100 mm • 16 x 75 mm
• 13.25 x 78 mm • 16 x 100 mm
• 14.0 x 100 mm • 16.2 x 100 mm
• 15.3 x 75 mm • 16.5 x 92 mm.
Sample cups may be placed directly on Sample disk
the sample disk or on top of 16 mm
primary sample tubes.

2-8 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
 2.3 Sample/Reagent Area Components

Rack Sampler
The rack sampler consists of an A-Line, B-Line, C-Line and STAT position.
A-Line
Specimens are placed in 5-position sample racks and are loaded onto a tray.
Once a tray is loaded, additional racks can be added to the tray one at a time
during operation, provided the tray indication light is green (ON). If the light is out
(OFF), the pusher arm is preparing to move. The pusher arm is located at the far
left of the A-Line and pushes the sample racks forward and onto the B-Line.
The A-Line holds a tray that accommodates 15 racks at one time. Another five
racks can be in the input buffer. Therefore, you can have a total of 100 specimens
loaded at any one time. Refer to the photo and graphic below.
Tray Tray Tray
Part 3 Part 2 Part 1

Output
C-Line buffer
Input buffer tray
indication
light

B-Line
Rack pusher arm (hidden)
5 racks 5 racks 5 racks 5 racks

Input
A-Line A-Line buffer
tray
indication
light

STAT
Tray indication light

A-Line of the rack sampler

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 2-9
2.3 Sample/Reagent Area Components
B-Line
The B-Line transports the sample racks, single file, first to the rack bar code
reader. Here each position in the rack is scanned for a sample bar code. After the
last position is scanned, the bar code reader scans the rack ID. After the last
specimen is sampled, the rack is transferred to the output buffer of the C-Line.
Refer to the photo and graphic below.

Rack bar code reader Tray Tray Tray

Part 3 Part 2 Part 1

Output
C-Line buffer
tray
indication

B-Line
light

B-Line
5 racks 5 racks 5 racks 5 racks

Input
A-Line buffer
tray
indication
light

STAT
B-Line of the rack sampler

Rack Bar Code Reader

The rack bar code reader reads both sample bar code labels and the rack bar
code label. The bar code reader is auto-discriminating, allowing the use of various
types of bar codes during operation. Bar code symbologies read include:
• NW7 (Codabar)
• Code 39
• Code 128
• Interleaved 2 of 5.

Rack bar code reader

2-10 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
 2.3 Sample/Reagent Area Components
C-Line
Racks are off-loaded from the B-Line into the output buffer. Like the input buffer,
this space holds five racks. When the sixth rack is moved into the output buffer, a
rack is pushed onto the tray on the C-Line. You can remove the tray from the
C-Line any time the tray indication light is green (ON). If the light is out (OFF), the
system is preparing to push a rack onto the C-Line tray. You cannot remove
single racks from the C-Line. You must remove an entire tray at one time.
If the tray is removed, the system continues to push racks into the output buffer. If
the buffer fills and there is no tray, the analyzer issues an alarm and stops
sampling racks.

Tray Tray Tray

Part 3 Part 2 Part 1

Output
C-Line buffer
tray
indication
light
Output buffer

B-Line
5 racks 5 racks 5 racks 5 racks

C-Line A-Line
Input
buffer
tray
indication
light

Tray indication light

STAT
(hidden)

C-Line of the rack sampler

Output buffer with racks

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 2-11
2.3 Sample/Reagent Area Components
STAT Position
The STAT position is located at the front of the analyzer and is in line to feed
directly onto the B-Line. Place a rack in the position as directed on the label and
press the Q key. When the rack currently being sampled is completed, the
STAT rack is pushed onto the B-Line and is sent on to the rack bar code reader
and sampling position.

Tray Tray Tray

Part 3 Part 2 Part 1

Output
C-Line buffer
tray
indication
light

B-Line
5 racks 5 racks 5 racks 5 racks

Input
A-Line buffer
tray
indication
light

STAT
STAT position

STAT position of the rack sampler

Sample Rack
Sample cups, primary sample tubes, calibrator or control vials are placed in
sample racks shown below. Each sample rack holds a maximum of five samples.
Each tube slot contains adapters that allow the rack to hold different sizes of
primary sample tubes. Each rack has a unique ID found on the bar code label on
the back end of the rack. This rack ID is read by the bar code reader and
transferred to the system. This ID appears on the screens in the software and on
the reports.

Rack ID bar code

Slot for tube

Tray guide

Sample rack

2-12 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
 2.3 Sample/Reagent Area Components

Sample/Reagent (S/R) Probe

The sample/reagent probe is located on the back left wall of the analyzer and is
mounted on an arm (S/R arm) that moves horizontally between the sample and
reagent disk. The probe uses disposable tips to control sample carryover, and has
liquid level and clot detection for accurate pipetting. Liquid level detection is
accomplished by capacitance. Clot detection is accomplished by a pressure
transducer.
A new assay tip is utilized with every new pipetting sequence. For example,
TSH = 1 tip for R1, R2 and sample, then 1 new tip for microparticles. The tip is
washed externally at the rinse station between each aspiration. Additional tips are
used for sample dilutions or pretreatment.

S/R probe with tip

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 2-13
2.3 Sample/Reagent Area Components

Bar Code Reader

During a sample scan, the bar code reader scans the information on the bar code-
labeled primary sample tubes, calibrators or controls, and transmits it to the
software. During a reagent scan, the reader rotates to the reagent disk side to
read the 2-dimensional bar code labels on the reagent packs.
The bar code reader is located toward the back wall of the analyzer.
On the disk system:
• it can be seen when either the sample disk or reagent disk is removed.
• to read bar code labels, the bar code reader rotates between the sample
and reagent disks, and the card reading station.

On the rack system:

• it can only be seen when the reagent disk is removed.
• to read bar code labels, the bar code reader rotates between the reagent
disk and the card reading station.

The bar code reader is auto-discriminating, allowing the use of various types of
bar codes during operation. The bar code symbologies read include those
previously described in the rack bar code reader subsection. In addition, this bar
code reader also reads PDF417.

n
PDF417 can only be used for reagent bar codes and bar code cards.

Bar code reader (sample disk side) Bar code reader (reagent disk side)

2-14 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
 2.3 Sample/Reagent Area Components

Bar Code Card Reading Station

At this station, the bar code
reader scans calibrator and control
information from the calibrator or control
bar code card. These cards are packed in
calibrator or control kits.
On the disk system:
• it is located between the sample disk
and reagent disk.
On the rack system:
• it is located to the back left of the
reagent disk.

Bar code card reading station

Reagent Disk
The reagent disk contains 18 positions.
Three positions can be used for universal
diluent, pretreatment reagent or additional
assay reagents. A maximum of 15 assays
can be loaded on the disk at one time. The
reagent disk is temperature controlled at
20 ± 3 °C.

n
Diluent or pretreatment reagent can
be placed in ANY position on the
reagent disk. Any additional
reagent packs placed on the disk must
be for one of the 15 assays currently
on the reagent disk. For example, you
may have the maximum of 15 assays Reagent disk
occupying the 18 available disk
positions, or you may have only a few assays divided amongst the 18
available disk positions.

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 2-15
2.3 Sample/Reagent Area Components

Reagent Cap Open/Close Mechanism

To prevent reagents from evaporating,
and to promote ease of use for the
operator, the reagent disk utilizes a
reagent cap open/close mechanism
during reagent pipetting. The mechanism
is located on the back wall of the reagent
disk compartment and emerges when
reagents need to be opened or closed.
Caps are opened prior to pipetting or
mixing the specific reagent (e.g., R1, R2
or M) and are closed when pipetting or
mixing for the specific reagent (e.g., R1,
R2 or M) is completed.

Reagent cap open/close mechanism

Microparticle Mixer
The mixer is utilized to mix the microparticles to ensure a homogenous solution
before aspiration. The mixer is located to the right of the reagent disk. In its home
position, it occupies the space directly to the left of the S/R probe.

Microparticle mixer

2-16 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
 2.3 Sample/Reagent Area Components

Probe/Mixer Rinse Station

The rinse station rinses the assay tip or
mixer externally with deionized water
between aspirations, or before and after
microparticle mixing. The rinse station is
located below the S/R probe and mixer
when the probe is in its Stand-by position
and the mixer is in its home position.

‡
Rinse station

Sample/Reagent (S/R) Pipettor

The S/R pipettor is located on the back
right of the analyzer. The pipettor is filled
with deionized water and uses positive
displacement to aspirate and dispense
from the S/R probe.

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 2-17
2.4 Consumables Area Components

Introduction
The consumables area consists of three
assay cup trays, three tip trays, gripper,
incubator, cup disposal opening, pipetting
station, liquid waste container, distilled
water container and solid waste tray
and liner.
One tip tray holds up to 120 tips, and one
cup tray holds up to 60 cups. Therefore, a
total of 360 tips and 180 cups can be
placed on the analyzer.
Tip tray and cup tray

Gripper
The gripper can move in three
directions: Position 1 Position 2

• X (left and right)

• Y (forward and back)
• Z (up and down).
It is also equipped with a gripping
finger for gripping a tip or assay cup. Tray 3
The gripping finger grips a tip from
the tip tray, or a cup from the cup Z
tray and delivers it to the pipetting
station. Then, at the appropriate Y
time, the gripper moves the assay
cup to the incubator, then to the
X
aspiration station, and finally to the
cup disposal opening.
During operation, the analyzer starts
utilizing tips and cups from tray 1,
position 1. As soon as tray 1 is
Tray 1
empty, the analyzer starts using tray 2.
As soon as tray 2 is empty, the
analyzer continues with tray 3.
When tray 3 is empty, the analyzer Gripper and trays
returns to tray 1.

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 2.4 Consumables Area Components

Cup Disposal Opening

Assay cups are discarded through a cup
opening located directly to the left of the
incubator.
Cup disposal opening

Cup disposal opening

Pipetting Station
A five position pipetting station is
located to the upper left of the incubator.
Tip eject station
Assay cups and tips are moved by the
gripper to this location for sample and
reagent pipetting, sample dilution and
sample pretreatment. The assay tips Position 1
are discarded at the tip eject station in
the right most position of the station.
Positions 1 and 2 are used for tips and Position 5
positions 3 and 4 are used to hold cups for
dilution or pretreatment. Position 5 is the
position where the S/R probe pipettes
sample and reagent.

Pipetting station

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 2-19
2.4 Consumables Area Components

Distilled Water Container

The distilled water container is located in
front of the pipettors and to the right of the
liquid waste container. It holds three
liters of distilled water. An alarm is issued
when the distilled water container is empty.
A float mechanism sensor located beneath
the aspiration inlet, triggers the alarm
on the INVENTORY screen.

n
Removing the distilled water
container during operation
causes the analyzer to enter
P. Stop status.

Distilled water container

Liquid Waste Container

The liquid waste container is located in
front of the ProCell and CleanCell
reagents. It holds four liters of waste and
issues an alarm when approximately three-
quarters full. The alarm is triggered by
a weight-sensitive mechanism that
activates a photosensor located
in the compartment holding the container.
An alarm is also issued when the container
is improperly positioned. This alarm is
triggered by a plate mechanism that
activates a photosensor located at the
front of the compartment.

n
Removing the liquid waste container
during operation or an improperly Liquid waste container
positioned container causes the
analyzer to enter E. Stop status.

2-20 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
 2.4 Consumables Area Components

Solid Waste Tray and Liner

The solid waste tray and liner is located
behind the front access door on the
analyzer. Used assay cups and tips are
discarded into the waste tray during
operation.
A disposable liner (Clean-Liner) made of
polystyrene is placed inside the solid
waste tray. The Clean-Liner has a sliding
cover to reduce potential splashing and to
prevent tips and cups from falling out of
the tray. The tray shakes periodically
during operation so that used tips and
cups do not accumulate at one end of
the tray.
Solid waste tray and liner
An alarm is issued when either the tray
is full or if the tray and liner are missing. The presence of a tray is monitored by a
photosensor.

n
Removing the solid waste tray during operation causes the analyzer to enter
E. Stop status.

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 2-21
2.5 Measuring Area Components

Introduction
The measuring area includes the incubator, aspiration station, sipper probe, sipper
rinse station, sipper pipettor, system reagents (ProCell and CleanCell) and the
detection unit.

Incubator
The incubator is maintained at a specific
temperature (37.0 °C ± 0.3 °C) for the
reaction of the sample and the reagents Aspiration station
that have been dispensed into a cup. The
incubator is equipped with 32 positions.
When an assay is ready for measurement,
the assay cup is transferred by the gripper
to the aspiration station, and the sipper
probe aspirates the reaction mixture for
measurement. The aspiration station,
located in the lower right corner of the
incubator, is not temperature controlled.

Incubator

2-22 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
 2.5 Measuring Area Components

Sipper Probe
The sipper probe aspirates the reaction mixture into the measuring cell. ProCell
and CleanCell are also aspirated by the sipper probe. The sipper probe is located
to the right of the incubator.
The sipper rinse station externally washes the sipper probe with distilled
water between measurements. When the sipper probe is in its Stand-by position,
the probe is located directly above the rinse station.

Sipper probe and rinse station

Sipper Pipettor
The sipper pipettor is located directly
to the right of the sample/reagent
pipettor. It uses positive displacement
of water to aspirate and dispense from
the sipper probe.

Sipper pipettor

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 2-23
2.5 Measuring Area Components

System Reagents (ProCell and CleanCell)

ProCell and CleanCell are located
behind the liquid waste container.
ProCell is the buffer solution containing Bottle Set 1 Bottle Set 2
tripropylamine (TPA). These bottles are
identified with white caps.
CleanCell is the cleaning solution used
to clean the measuring cell after
measurement. CleanCell bottles are
identified with black caps.
The reagent compartment is keyed to
ensure the correct reagent is placed in 1 (PC) 2 (CC) 3 (PC) 4 (CC)
the proper position. Two bottles of each
reagent are stored on the analyzer,
temperature controlled at 28.0 °C ± 2.0 °C.
ProCell (PC) and CleanCell (CC)

When starting from Stand-by, the sipper probe always attempts to first use ProCell
and CleanCell from bottle set 2. If the quantity is insufficient, bottle set 1 is used.
When starting from S. Stop or R. Stop, the bottle set in use when the analyzer was
previously in Operation is pipetted. When the volume of that bottle set becomes
insufficient, the sipper probe changes to the other bottle set.
The analyzer can operate with one bottle set of ProCell and CleanCell reagent, but
they must be placed in positions 1 & 2 or 3 & 4. Refer to the photograph above.

2-24 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
 2.5 Measuring Area Components

Detection Unit
The detection unit is the core of the Elecsys 2010 system. The detection unit
contains the photomultiplier tube, peltier, flow-through measuring cell, magnet
drive assembly and an amplifier circuit board. The temperature is maintained at
28.0 °C ± 0.5 °C.
counter optical distance
electrode window washer
screw top cell

cell gap

gasket

o-ring
diaphragm

reference
electrode

movable
magnet
cell body
working outlet
inlet fitting
electrode fitting

Measuring cell of the detection unit

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 2-25
2.6 Power Components

Operation ON/OFF Switch

The operation ON/OFF switch is located on the
lower left front side of the analyzer. Use this
switch to turn OFF the analyzer to perform
certain maintenance procedures or when the
system is not in use for extended periods of time
(e.g., overnight). The operation switch also turns
OFF the power to the touchscreen.
Provided the circuit breaker is ON, the reagent
disk and system reagent compartment
temperatures are maintained while the operation
switch is OFF.

Operation ON/OFF switch

Circuit Breaker
The circuit breaker is located on the right side panel
of the analyzer above the power supply cord. The
circuit breaker controls the power supplied to the
temperature controlled reagent compartments when
the operation switch is OFF. The circuit breaker must
be in the “I” (ON) position whenever reagents are
stored on the analyzer and to maintain liquid in the
measuring cell.

n
To disconnect the analyzer from the supply
source, the circuit breaker must be in the
“O” (OFF) position and the power cord must Circuit breaker
be removed.

Rack Circuit Breaker

There is a circuit breaker located on the left side of
the rack sampler. This controls power to the sampler
unit. The circuit breaker should be kept in the “I”
(ON) position at all times. Use the operation switch
to power ON and OFF the rack system.

n
To disconnect the analyzer from the supply
source, the circuit breaker must be in the “O”
(OFF) position and the power cord must
be removed.
Rack circuit breaker

2-26 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
 2.7 Technical Data

Product Name :Immunoassay System Product Name :Immunoassay System

Model :2010 Model :2010
Part No. : 741 - 0011 Part No. : 741 - 0011
Serial No. : 0802-12 Serial No. : 0802-11
Supply Voltage : AC100-120V Supply Voltage : AC200-240V
Frequency :50/60Hz Frequency :50/60Hz
Power Consumption :800VA Power Consumption :800VA
Manufactured by : Manufactured by :
Hitachi, Ltd. Tokyo Japan Hitachi, Ltd. Tokyo Japan
741-1570 741-1570

Analyzer plate (US) Analyzer plate (Europe)

Instrument Dimensions

Analyzer Height Depth Width Weight

22.05 in
(56 cm) 28.7 in 47.2 in ~ 375 #
[not including (73 cm) (120 cm) (170 kg)
the touchscreen]

22.05 in
(56 cm) 37.5 in 67.2 in ~ 462 #
[not including (95 cm) (170 cm) (210 kg)
the touchscreen]

Electrical
Installation requirements Pollution degree: 2 (IEC 1010-1)
Overvoltage category: II (IEC 664)
The Elecsys 2010 analyzer must be
connected to a three-wire power supply
cord with a safety ground.
Supply voltage/frequency 100-120 VAC 50/60 Hz single phase or
200-240 VAC 50/60 Hz single phase
The range of supply voltage and frequency
should only be configured to laboratory
specifications by Boehringer Mannheim
service personnel.
Power consumption 800 VA
Heat generation approx. 2,879 kJ/hr resp.
688 kcal/hr resp.
2,730 Btu/hr

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 2-27
2.7 Technical Data

Environmental Conditions
Temperature 18 °C to 32 °C
64.4 °F to 89.6 °F
Temperature variation Max. ± 2 °C/hour
Max. ± 3.6 °F/hour
Humidity 20% to 80%

Noise Level (DIN 43635)

Stand-by level 60 dBA
Operation level (average) 63 dBA
Operation level (maximum) 70 dBA

Water Supply
Water container 3 Liters
Water requirements < 10 µS/cm or > 0.1 megohm, bacteria-free
Water consumption approx. 3 L for 250 tests
approx. 12 mL/cycle

Liquid Waste
Liquid waste container 4 Liters

Throughput Rate
Assay measurements approx. 86 tests/hour

Sampling System
Sample/Reagent pipettor
principle conductive disposable tip handling
Sample/Reagent pipettor
precision < 1.5% CV at 10 µL
< 1% CV at 50 µL
Sample volume per test 10 µL to 50 µL
Sample detection Liquid level detection and clot detection

2-28 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
 2.7 Technical Data
Sample loading capacity 30 positions for samples, controls and
calibrators
tray – 15 racks with 5 positions each for
samples, controls and calibrators = 75
tray with input buffer – 20 racks with 5
positions each = 100
STAT capacity any unoccupied position on the sample disk
STAT position at the front of the analyzer
Bar code symbologies PDF417
NW7 (Codabar)
Code 39
Code 128
Interleaved 2 of 5
Assay tips 360 tips (3 trays; 120 tips/tray)
Assay cups 180 cups (3 trays; 60 cups/tray)
Sample cups 2 mL (Standard) Hitachi cup
Primary sample tubes 13 x 75 mm 15.65 x 100 mm
13 x 100 mm 16 x 75 mm
13.25 x 78 mm 16 x 100 mm
14.0 x 100 mm 16.2 x 100 mm
15.3 x 75 mm 16.5 x 92 mm

Sample container dead volume

Sample Container Tube “Normal” “Reduced”

height dead volume† dead volume†
standard Hitachi cup directly on the sample disk — 300 µL 110 µL
standard Hitachi cup on top of a primary sample 75 mm 300 µL 150 µL
tube (d* = 16 mm)
standard Hitachi cup on top of a primary sample 100 mm 360 µL 150 µL
tube (d* = 16 mm)
primary sample tube (d* = 13 mm) 75 mm 750 µL —
primary sample tube (d* = 13 mm) 100 mm 750 µL —
primary sample tube (d* = 16 mm) 75 mm 1000 µL —
primary sample tube (d* = 16 mm) 100 mm 1000 µL —
calibrator/control vial — 200 µL —

* “d” represents the outside diameter of the sample tube.

† Dead volume may vary depending on the hardware retrofit level.

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 2-29
2.7 Technical Data
Sample container dead volume

Sample Container Tube “Normal” “Reduced”

height dead volume dead volume
standard Hitachi cup directly on the sample rack — 250 µL 100 µL
standard Hitachi cup on top of a primary sample 75 mm 350 µL 200 µL
tube (d* = 16 mm)
standard Hitachi cup on top of a primary sample 100 mm 500 µL 200 µL
tube (d* = 16 mm)
primary sample tube (d* = 13 mm) 75 mm 600 µL —
primary sample tube (d* = 13 mm) 100 mm 600 µL —
primary sample tube (d* = 16 mm) 75 mm 1000 µL —
primary sample tube (d* = 16 mm) 100 mm 1000 µL —
calibrator/control vial — 200 µL —

* “d” represents the outside diameter of the sample tube.

Reagent System
Reagent capacity 15 assays in 18 reagent positions
R1/R2 consumption 50 to 80 µL per reagent dependent upon the
assay
Microparticle consumption 30 to 50 µL dependent upon the assay
Reagent detection liquid level detection
Positive reagent identification 2-dimensional bar code (PDF417)
Automatic dilution available up to 1:100
Evaporation protection reagents are automatically opened and
closed
Inventory control automatic based on counting (reagent disk)
or liquid level detection (ProCell/CleanCell)

Incubation System
Incubator capacity 32 assay cups
Volume of assay cups 200 µL
Incubation temperature 37.0 °C ± 0.3 °C

2-30 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
 2.7 Technical Data

Measuring System
Measuring method integral measuring of an
electrochemiluminescent signal
Calibration mode 2-point calibration
Test protocols 26 test methods
ProCell consumption approx. 2 mL per cycle
CleanCell consumption approx. 2 mL per cycle

Control System
Floppy disk 3 1/2 inch / 1.44 MB / high density
Host interface CCITT V. 24/RS-232-C (bidirectional)
The host computer should comply with the
requirements of IEC (950).
External printer parallel (Centronics)
Optional module Laboratory System Manager (LSM)
Touchscreen monitor VGA - LCD with 640 x 480 pixel

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 2-31
 Notes

2-32 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
Chapter 3
Mechanical Theory

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 3-1
3.1 Mechanical Theory

Introduction
The Elecsys 2010 analyzer automates the immunoassay reactions utilizing
electrochemiluminescence (ECL). These reaction methods are described in detail
in Chapter 4, ECL Technology. The individual test steps and how the system
performs the necessary procedures are discussed here.

Test Protocols
There are 26 test protocols or test steps that can be used on the analyzer. These
protocols are predefined by Boehringer Mannheim for each test and cannot be
changed by the operator.

General Assay Sequence

An immunological ECL test is made up of various pipetting steps, at least one
incubation period and a measurement step. Generally at least three test
components (sample, reagent and microparticles) are pipetted into an assay cup.
After the appropriate incubation period, the reaction mixture is aspirated into the
measuring cell where the measurement process takes place. Each of the required
pipetting cycles is performed within a defined period (42 seconds).
The number of pipetting steps, as well as the make up of the reaction mixture are
dependent on the test method (1 or 2 step test). For some methods, predilution
with diluent and/or pretreatment with a special reagent is necessary. Thus the
number of pipetting steps is increased.
After each pipetting step the sample/reagent (S/R) probe tip is cleaned and, if
necessary, the microparticle mixer and sipper probe are also cleaned.
The following steps apply in principle to all methods. The sequence of the
individual processes differ from test to test.

Preparative Operations
Once the analyzer’s power is turned ON, the initialization process is started.
During initialization, the mechanisms are reset to their home positions.

Run operation
After the appropriate test selections are made in the software for patient samples,
operation is started according to the predetermined test protocol for each assay
selected. Initially, at least one reagent (R1 or R2) and the sample or microparticles
(M) are aspirated one after another by the S/R probe. After each aspiration, the
outside of the S/R probe tip is cleaned at the rinse station. The sample and
reagents are dispensed into a new assay cup and the assay tip is ejected into the
solid waste tray.

3-2 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
 3.1 Mechanical Theory
For some tests that require sample dilution or pretreatment, diluent or
pretreatment reagent is pipetted together with sample into an assay cup. An
aliquot of the diluted/pretreated sample is then dispensed with reagent into a
second assay cup. Therefore, certain tests with predilution/pretreatment may
require two or more assay cups. For additional information refer to Section 3.3,
Dilution Steps.

First Incubation at 37 °C
The incubation times are 4.5 or 9 minutes long, depending on the test. Some tests
require only one incubation, whereas tests with pretreatment can require up to
three incubation periods. During the incubation step(s) the immune complex
products are formed.

If using an assay that requires pretreatment, the first incubation (9 min.) is for
sample and pretreatment reagent(s).

Additional Reagent Pipetting

Some assays (usually those with multiple incubation steps) require additional
reagent pipetting. As in the initial reagent pipetting step, a new pipette tip is
picked up prior to reagent aspiration. The S/R probe tip is washed at the rinse
station after each liquid aspiration. The liquid is then dispensed into the
corresponding assay cup where the sample and other liquids were dispensed in
the first pipetting step. The probe rises while dispensing the reaction mixture back
into the cup, thereby mixing the solution and accelerating the reaction in the cup.
The pipette tip is ejected into the solid waste tray when pipetting is complete.

Second Incubation at 37 °C
If necessary, a second incubation step (4.5 or 9 minutes) occurs.

If using a pretreatment assay, the second incubation is similar to that described

above for “First Incubation at 37 °C.”

Additional Reagent Pipetting (Pretreatment assays)

For pretreatment assays, reagent pipetting similar to that described above for
“Additional Reagent Pipetting” occurs.
Third Incubation at 37 °C (Pretreatment assays)
If necessary, a third incubation step (9 min) occurs for pretreatment assays.
Reaction Mixture Aspiration and Measurement
In this process the sipper probe first aspirates ProCell (Tripropylamine solution,
TPA) to prepare the measuring cell. Then, the sipper probe aspirates the reaction
mixture from the assay cup and transfers it to the measuring cell. The sipper
probe is washed at the rinse station and ProCell is aspirated again to rinse away
the unbound reagent and sample constituents. Next, the ECL reaction in the
measuring cell occurs.

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 3-3
3.1 Mechanical Theory
Measuring Cell Cleaning and Results
Once the measurement is complete, the measuring cell is cleaned with CleanCell
and prepared for a new measurement process.
It takes 42 seconds (one pipetting cycle) from the aspiration of the reaction
mixture by the sipper probe until the measuring cell is filled with ProCell and ready
for the next sample.

Finalization
When all the requested tests have been performed, the sipper pipettor flushes
deionized water through the sipper probe, and then fills the measuring cell with
ProCell before the analyzer’s status returns to Stand-by.

3-4 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
 3.1 Mechanical Theory

Operation Flow In Analysis

An operational flow chart is shown below.

Power ON

Initialization

Stand-by
Press Start

Operation
Sample dilution, if necessary
Sample pretreatment, if necessary
Sample pipetting
R1 pipetting
R2 pipetting
Microparticle pipetting
Incubation

Sipper Aspiration

Transport to
Measuring Cell

Capture
Microparticles

Electrochemiluminescence
Measure by
Photomultiplier Tube

Clean with
CleanCell

Rinse with
ProCell

Finalization

Stand-by

Power OFF

Operational flow chart

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 3-5
3.2 Detailed Assay Sequence

Introduction
The mechanical process of the instrument is described below using a sandwich
test, TSH, as an example. This example assumes that the reagent pack was
already registered by the analyzer and does not need calibration. All results are
calculated based on an existing Lot-Calibration.

Preoperation Steps
When S is pressed from Stand-by, the following preoperative steps occur.

A. The analyzer resets all mechanisms to their respective home positions and
accesses the data disk. Next, the S/R pipettor primes the S/R probe.
B. The gripper checks for a tip in position number 1 of the tip trays. If this
position is empty, the gripper remembers where it last left off and checks
that position. If this position is empty, the gripper considers the whole tray
empty and the INVENTORY screen is updated accordingly.

n
If the analyzer is in S. Stop, the gripper remembers where it last left
off and checks for a tip in that position.

1. During the tip check, the S/R probe is checked for the presence of a tip.
The probe moves to the tip eject station and performs the movements
to eject a tip. If a tip is present it is ejected.
2. After the tip check is complete, the assay cups are checked in the same
manner. During the cup check, the analyzer finishes priming the probes.
3. Next, the gripper checks the last three of the five positions on the
pipetting station.
a. If a cup is present, the analyzer goes through the steps of a cup
disposal. The gripper places a tip in position 1 of the pipetting station.
Then, the S/R probe picks up the tip in position 1 of the pipetting
station. The S/R probe descends into the assay cup and attempts to
aspirate any possible liquid from the cup. The gripper picks up the
cup and discards it into the cup disposal opening. As the cup is
disposed, the S/R probe moves to the rinse station and dispenses any
aspirated liquid. The tip is then washed and discarded.
4. The gripper moves to the incubator where it checks all 32 incubator
positions. If a cup is present, the gripper moves the cup to position 5 on
the pipetting station and uses the same procedure listed in step a. to
discard the cup.
5. The S/R probe tip is ejected after all the incubator positions are checked.

3-6 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
 3.2 Detailed Assay Sequence

Dispense Reagent 1, Reagent 2 and Sample

A TSH sample is present on position 1 of the sample disk.
A. After preoperation functions are complete, the gripper takes a tip from the
tip tray and transports it to position 1 of the pipetting station. The gripper
returns to its Stand-by position.
B. The sample disk rotates until position 1 is in the sampling position.
C. The S/R probe moves to position 1 of the pipetting station, descends to
obtain the tip, rises and returns to its Stand-by position.
D. During this time, the reagent disk rotates until the TSH reagent pack is at
the cap open/close mechanism. The mechanism moves forward and opens
the caps on the reagent pack. The disk rotates again to move the TSH
reagent to the R1 position.
E. The S/R probe moves from its
Stand-by position to the R1
aspiration position. While
activating liquid level detection,
the probe descends until it is
2 mm below the reagent surface
and aspirates 60 µL of R1.
R1 aspiration position

n
The lowest allowable
point the S/R probe can
descend to is 1.3 mm
above the inside bottom
of the reagent pack.
1. While aspirating R1, the gripper puts another tip in position 1 of the
pipetting station.
F. If the S/R probe does not detect liquid during descent, no reagent
aspiration can occur. Alarm 37-01-02 (Assay reagent short) is generated.
G. After R1 aspiration, the S/R probe rises and moves to the rinse station. To
prevent the aspirated R1 from contacting the water in the rinse station, the
probe aspirates 10 µL of air. The rinse station externally washes the tip.
H. During step G, the reagent disk rotates until the TSH reagent pack is in the
R2 position.

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 3-7
3.2 Detailed Assay Sequence
I. The S/R probe moves from the
rinse station to the R2 position
while aspirating another 10 µL
of air. This air layer prevents R1
from mixing with R2. While
activating liquid level detection,
the probe descends until it is
2 mm below the reagent surface R2 aspiration position
and aspirates 50 µL of R2.
1. While aspirating R2 the
gripper moves an assay cup
to position 5 of the pipetting
station.
J. Upon completion of R2 aspiration, the S/R probe rises and moves to the
rinse station. To prevent the aspirated R2 from contacting the water in the
rinse station, the probe aspirates another 10 µL of air. The rinse station
externally washes the tip.
K. After R2 aspiration, the reagent disk rotates until the TSH reagent pack is at
the cap open/close mechanism. The mechanism moves out and closes the
caps.
L. The S/R probe moves from the rinse
station to the sampling position while
aspirating another 10 µL of air. While
activating liquid level detection, the
probe descends until it is 2 mm below
the sample surface and aspirates 50 µL
of sample. During sample aspiration,
clot detection is activated.
M. The S/R probe moves from the
sampling position to position 5 of the
pipetting station. The probe descends
until the tip reaches 2 mm below where
Sampling position
the calculated level of the reaction
mixture surface should be and
dispenses the sample, R2 and R1. The probe’s downward displacement is
determined by calculating the reaction mixture volume for the sample and
utilizing downward displacement tables in the software. The probe does
not rise during dispense.
N. After dispense, the S/R probe moves to the tip eject position and ejects the
tip.

3-8 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
 3.2 Detailed Assay Sequence

Dispense Reagent 1, Reagent 2 and Sample

A TSH sample is present on position 1 of the sample rack.
A. After preoperation functions are complete, the gripper takes a tip from the
tip tray and transports it to position 1 of the pipetting station. The gripper
returns to its Stand-by position.
B. The pusher arm pushes the racks in the A-Line forward to the B-Line. The
arm returns to its home position. The first rack loads on the B-Line.
C. As the rack incrementally moves on the B-Line, the rack bar code reader
scans all five rack positions and rack ID. When scanning is complete,
position 1 of the rack is in the sampling position.
D. The S/R probe moves to position 1 of the pipetting station, descends to
obtain the tip, rises and returns to its Stand-by position.
E. During this time, the reagent disk rotates until the TSH reagent pack is at
the cap open/close mechanism. The mechanism moves forward and opens
the caps on the reagent pack. The disk rotates again to move the TSH
reagent to the R1 position.
F. The S/R probe moves from its
Stand-by position to the R1
aspiration position. While
activating liquid level detection,
the probe descends until it is
2 mm below the reagent surface
and aspirates 60 µL of R1.
R1 aspiration position

n
The lowest allowable
point the S/R probe can
descend to is 1.3 mm
above the inside bottom
of the reagent pack.
1. While aspirating R1, the gripper puts another tip in position 1 of the
pipetting station.
G. If the S/R probe does not detect liquid during descent, no reagent
aspiration can occur. Alarm 37-01-02 (Assay reagent short) is generated.
H. After R1 aspiration, the S/R probe rises and moves to the rinse station. To
prevent the aspirated R1 from contacting the water in the rinse station, the
probe aspirates 10 µL of air. The rinse station externally washes the tip.
I. During step H, the reagent disk rotates until the TSH reagent pack is in the
R2 position.

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 3-9
3.2 Detailed Assay Sequence
J. The S/R probe moves from the
rinse station to the R2 position
while aspirating another 10 µL
of air. This air layer prevents R1
from mixing with R2. While
activating liquid level detection,
the probe descends until it is
2 mm below the reagent surface R2 aspiration position
and aspirates 50 µL of R2.
1. While aspirating R2 the
gripper moves an assay cup
to position 5 of the pipetting
station.
K. Upon completion of R2 aspiration, the S/R probe rises and moves to the
rinse station. To prevent the aspirated R2 from contacting the water in the
rinse station, the probe aspirates another 10 µL of air. The rinse station
externally washes the tip.
L. After R2 aspiration, the reagent disk rotates until the TSH reagent pack is at
the cap open/close mechanism. The mechanism moves out and closes the
caps.
M. The S/R probe moves from the
rinse station to the sampling
position while aspirating another
10 µL of air. While activating
liquid level detection, the probe
descends until it is 2 mm below
the sample surface and aspirates
50 µL of sample. During sample
aspiration, clot detection is
activated.
N. The S/R probe moves from the
sampling position to position 5 of
the pipetting station. The probe Sampling position
descends until the tip reaches
2 mm below where the calculated level of the reaction mixture surface
should be and dispenses the sample, R2 and R1. The probe’s downward
displacement is determined by calculating the reaction mixture volume for
the sample and utilizing downward displacement tables in the software.
The probe does not rise during dispense.
O. After dispense, the S/R probe moves to the tip eject position and ejects the
tip.

3-10 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
 3.2 Detailed Assay Sequence

First Incubation
A. The gripper grasps and transports the cup containing the reaction mixture
from the pipetting station to the incubator.
B. The cup is incubated at 37 °C for nine minutes.
C. During incubation, the analyzer continues to perform operations for other
test(s) or sample(s), if necessary.

Microparticle Preparation
Before the first incubation is completed, the TSH microparticles are mixed to
facilitate microparticle aspiration and dispense.
A. The reagent disk rotates until the TSH reagent pack is at the reagent cap
open/close mechanism. The mechanism moves out and opens the caps.
The disk moves the reagent pack to the mixing position.
B. The mixer moves over the
reagent disk and descends into
the microparticles to a level
1.4 mm above the inside bottom
of the bottle.

n
The mixer descends to
this level regardless of the
volume of microparticles
in the bottle. Mixing position

C. The mixer stirs the microparticles for 3.7 seconds to obtain a homogeneous
solution.
1. During the mixing, the gripper obtains a fresh assay tip and transports it
to position 2 of the pipetting station.
D. When mixing is complete, the mixer rises and returns to the rinse station
where it descends and rotates in the rinse station for washing.
E. At the same time, the reagent disk rotates the TSH reagent pack to the
microparticle pipetting position.

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 3-11
3.2 Detailed Assay Sequence

Microparticle Aspiration and Dispense

A. The gripper grasps the incubating cup and transports it to position 5 of the
pipetting station.
B. The S/R probe moves to the pipetting station and obtains the fresh tip and
moves to the microparticle pipetting position.
C. While activating the liquid level
detection, the S/R probe
descends to 2 mm below the
reagent surface and aspirates
40 µL of microparticles.
D. After reagent aspiration, the S/R
probe rises, moves to position 5
Microparticle position
of the pipetting station and
descends to dispense the
microparticles.
E. After dispense, the S/R probe
descends further until it is 0.8 mm
above the bottom of the cup and aspirates either the entire volume of
reaction mixture or 190 µL of the reaction mixture, whichever volume is
smaller. The probe rises while dispensing the reaction mixture back into the
cup, thereby mixing the solution and accelerating the reaction in the cup.
This mixing takes place only once.
F. The S/R probe moves to the tip eject position and discards the tip.

Second Incubation
A. The gripper grasps the cup containing the mixed reaction mixture and
returns it to the incubator.
B. The cup is incubated at 37 °C for nine minutes.
C. During incubation, the analyzer continues to perform operations for other
test(s) or sample(s), if necessary.

3-12 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
 3.2 Detailed Assay Sequence

Measurement Process Preparations

Before the second incubation is completed, the sipper probe aspirates ProCell
into the measuring cell to facilitate measurement.
A. The sipper probe moves from its home position to a ProCell bottle and
descends to 2 mm below the solution level and aspirates ProCell into the
measuring cell. During descent, liquid level detection is activated.

n
The sipper probe can descend as low as 1.3 mm above the bottom of
the ProCell bottle.

B. The sipper probe rises.

Measurement Process
A. The gripper grasps and transports the cup that has completed its second
incubation from the incubator to the aspiration station.
B. The sipper probe moves to the aspiration station and descends into the cup
until it is 0.8 mm above the cup bottom. This descent is independent of the
reaction mixture volume.
C. When the sipper probe detects the reaction mixture in the cup, it aspirates
150 µL.
D. After aspiration, the sipper probe rises, aspirates 10 µL of air and moves to
the sipper rinse station to descend for rinsing.
E. The gripper grasps the cup from the aspiration station, transports it to the
cup disposal opening and discards the cup.
F. The sipper probe is rinsed.
G. The sipper probe rises and moves to the ProCell position, descends into the
bottle and aspirates ProCell in a set aspiration/dispense sequence. The
immune complex is captured by the magnet onto the electrode of the
measuring cell. The ProCell washes away all unbound reagent and serum
constituents.
H. After the bound-free separation, a voltage is applied between the working
electrode and the counter electrode. The ECL reaction is initiated and
measured by the photomultiplier.

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 3-13
3.2 Detailed Assay Sequence
I. After measurement, the sipper probe rises and moves to the CleanCell
position and aspirates 20 µL of air. The probe then descends into the
CleanCell bottle and aspirates reagent. This procedure is repeated eight
times. The alternate flow of air and cleaning solution washes the measuring
cell. During this washing process, a voltage is applied between the
electrodes, which aids in the cleaning process.
J. The sipper probe moves to the sipper rinse station, aspirates 20 µL of air
and descends into the rinse station for washing.
K. Finally, the sipper probe rises and moves to the ProCell bottle. The probe
descends into the bottle and aspirates 500 µL of ProCell. Next, the probe
aspirates 90 µL of ProCell and moves to the rinse station. At the rinse
station, the probe dispenses 35 µL to flush the probe and prepare it for the
next sample. During the aspirations of the ProCell, a sequence of voltages
is applied three times to prepare the electrodes for the next measurement.
One cycle of the measurement process consumes approximately 2 mL each of
ProCell and CleanCell.

Signal Detection and Conversion

The measuring cell is kept at a constant 28 °C throughout the measurement
process. The photomultiplier tube detects and converts the ECL signal into an
electric signal from which the 2010 calculates assay results. For details on this
process, refer to Chapter 4, ECL Technology.

Automatic Analyzer Cycles

There are certain analyzer functions that occur automatically while the analyzer is
powered ON.
• While in operation, the solid waste tray periodically shakes for 1.5 seconds.
• While in Stand-by, the reagent disk turns 90° every 30 minutes.
• While in Stand-by, the rinse stations for the S/R probe and sipper probe are
switched on for 3 seconds every 30 minutes.
• Microparticles are mixed at 3 hour intervals, or during a reagent scan for a
new reagent pack.

3-14 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
 3.3 Dilution Steps

Dilution Steps
The following is a description of how an assay with a dilution is performed,
including the number of assay tips and assay cups used in the process.
Assay With One Step Dilution (3 tips and 2 cups)
Tip 1 ‹ diluent (wash)* + sample ‹ cup 1

Tip 2 ‹ R1 (wash)* + R2 (wash)* ‹ cup 2 ... 1st incubation

+ diluted sample from cup 1

Tip 3 ‹ M (wash)* ‹ cup 2 ... 2nd incubation

Detection
*(wash) = the outside of the assay tip is washed.
R1 = Reagent 1
R2 = Reagent 2
M = Microparticles

Assay With Two Step Dilution (4 tips and 3 cups)

Tip 1 ‹ diluent (wash)* + sample ‹ cup 1

Tip 2 ‹ diluent (wash)* ‹ cup 2

+ diluted sample from cup 1

Tip 3 ‹ R1 (wash)* + R2 (wash)* ‹ cup 3 ... 1st incubation

+ diluted sample from cup 2

Tip 4 ‹ M (wash)* ‹ cup 3 ... 2nd incubation

Detection
*(wash) = the outside of the assay tip is washed.
R1 = Reagent 1
R2 = Reagent 2
M = Microparticles

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 3-15
3.3 Dilution Steps

Pretreatment Steps
In certain test protocols, pretreatment reagent is added prior to R1, R2 or M.
Pretreatment Assay (3 tips and 1 cup)
Tip 1 ‹ PT1 (wash)* + PT2 (wash)* ‹ cup 1 ... 1st incubation
+ sample

Tip 2 ‹ R1 + pretreated sample in cup 1 ‹ cup 1 ... 2nd incubation

Tip 3 ‹ M (wash)* + R2 ‹ cup 1 ... 3rd incubation

+ reaction mixture in cup 1
Detection
*(wash) = the outside of the assay tip is washed.
PT1 = Pretreatment 1
PT2 = Pretreatment 2
R1 = Reagent 1
R2 = Reagent 2
M = Microparticles

3-16 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
 3.4 Analyzer Status Conditions

Introduction
The 2010 analyzer can occupy a number of status conditions. A table of the
status conditions you normally see during routine operation or maintenance
procedures is listed below. There are several other conditions that exist; however,
most of these status conditions are seen during various adjustment or
maintenance procedures performed by a Boehringer Mannheim representative.
These additional status conditions are not included in the table below.

A. Stop
The analyzer is no longer able to continue operation. An alarm was issued. Take
the appropriate measures to resolve the problem. For further details on A. Stop,
refer to Chapter 3, Instrument Alarms – User’s Guide.
A. Stop/L. Stop
The analyzer is already in A. Stop status when the lines stop operation. For further
details on A. Stop and L. Stop, refer to Chapter 3, Instrument Alarms – User’s
Guide.
A. Stop/R. Stop
The analyzer is already in A. Stop status when the A-Line stops supplying racks to
the B-Line. For further details on A. Stop and R. Stop, refer to Chapter 3,
Instrument Alarms – User’s Guide.
BC Card Scan
This status is seen when a bar code card scan is initiated from the ORDERS
screen.
E. Stop
An emergency stop condition exists. An alarm was issued. Take the appropriate
measures to resolve the problem. For further details on E. Stop, refer to Chapter 3,
Instrument Alarms – User’s Guide.
FD Access
This status occurs when a disk reading/writing utility is initiated from the
MAINTENANCE screen.
Finalization
The status of the analyzer when it is between the status conditions S. Stop and
Stand-by.
Initialization
This status is seen when the 2010 is powered ON or when S is pressed from
Stand-by.
L. and A. reset all
L. and A. reset all status occurs when the corresponding function is initiated from
the MAINTENANCE screen. This function resets the analyzer and the lines.

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 3-17
3.4 Analyzer Status Conditions
L. Stop
All lines stop operation. An alarm was issued. Take the appropriate measures to
resolve the problem. For further details on L. Stop, refer to Chapter 3, Instrument
Alarms – User’s Guide.
M. Cell preparation
M. Cell preparation occurs when this function is initiated from the MAINTENANCE
screen.
Operation
This is the status during which the 2010 performs its routine operations.
P. Stop
A partial stop condition exists. An alarm was issued. Take the appropriate
measures to resolve the problem. For further details on P. Stop, refer to Chapter 3,
Instrument Alarms – User’s Guide.
R. Stop
This status occurs when there are no more racks to process on the A-Line or B-
Line.
Rack clear
Rack clear status occurs when the corresponding function is initiated from the
MAINTENANCE screen. This function clears any remaining racks on the A-, B- or
C-Lines.
Reagent scan
This status is seen when a reagent scan is initiated from the INVENTORY screen.
S/R pipettor prime
This status occurs when the S/R pipettor prime is initiated from the
MAINTENANCE screen.
S/R probe LLD volt.
This status is seen when the analyzer is monitoring the liquid level detection
voltage of the S/R probe. The check is initiated from the VOLTAGE MONITOR
screen (UTIL) folder.
S. Stop
This status occurs when R is pressed or when sampling is complete (disk
system).
S. Stop-S. Scan
The analyzer is in S. Stop and a sample scan is requested from the ORDERS
screen, or S is pressed while the analyzer is in S. Stop.
Sample scan
This status occurs when a sample scan is initiated from the STATUS screen.

3-18 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
 3.4 Analyzer Status Conditions
Sipper LLD volt.
The analyzer is monitoring the liquid level detection voltage of the sipper probe.
The check is initiated from the VOLTAGE MONITOR screen (UTIL) folder.
Sipper pipet. prime
This status occurs when the sipper pipettor prime is initiated from the
MAINTENANCE screen.
Sleep
The operation switch is OFF and the circuit breaker is ON.
Stand-by
The analyzer is not performing any operations.
Stop
This status occurs when T is pressed or when a Stop alarm condition exists.
If an alarm exists, take the appropriate measures to resolve the problem. For
further details on Stop, refer to Chapter 3, Instrument Alarms – User’s Guide.
System reset
A system reset is initiated from the MAINTENANCE screen.

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 3-19
 Notes

3-20 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
Chapter 4
ECL Technology

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 4-1
4.1 ECL Technology

Introduction
The last years have seen the development and refinement of many new
immunoassay measurement principles and systems. The major trend has been
away from liquid phase assays with radioisotopic labels, and towards fast solid-
phase assays based on monoclonal antibodies. This development is moving
further towards precise and reliable non-isotopic, automated or semi-automated
laboratory assays with detection limits measured in the picomolar (10-12 ) and
attomolar (10 -18) range.

ECL Assay Principles

Electrochemiluminescent (ECL) processes are known to occur with numerous
molecules including compounds of ruthenium, osmium, rhenium or other
elements.
ECL is a process in which highly reactive species are generated from stable
precursors at the surface of an electrode. These highly reactive species react with
one another, producing light.
The development of ECL/Origen® immunoassays is based on the use of a
ruthenium(II)-tris(bipyridyl) [Ru (bpy) 32+ ] complex and tripropylamine (TPA). The final
chemiluminescent product is formed during the detection step.
The chemiluminescent reactions that lead to the emission of light from the
ruthenium complex are initiated electrically, rather than chemically. This is
achieved by applying a voltage to the immunological complexes (including the
ruthenium complex) that are attached to streptavidin-coated microparticles. The
advantage of electrically initiating the chemiluminescent reaction is that the entire
reaction can be precisely controlled.

4-2 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
 4.1 ECL Technology

Use of the Ruthenium Complex

ECL technology uses a ruthenium chelate as the complex for the development of
light. Salts of ruthenium-tris(bipyridyl) are stable, water-soluble compounds. The
bipyridyl ligands can be readily modified with reactive groups to form activated
chemiluminescent compounds.
For the development of ECL immunoassays, [Ru(bpy)3 2+] N-hydroxysuccinimide
(NHS) ester is used because it can be easily coupled with amino groups of
proteins, haptens and nucleic acids. This allows the detection technology to be
applied to a wide variety of analytes.

2+
O
O
N N

N N O
O
Ru
N N
N

The ruthenium complex

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 4-3
4.1 ECL Technology

The ECL Reaction at the Electrode Surface

Photon

Diffusion
Magnetic
TPA• microparticle
+
-H

TPA +
TPA•
–
e
– Electrode
e

Detection of a ruthenium-labeled immune complex

Two electrochemically active substances, the ruthenium complex and

tripropylamine (TPA), are involved in the reactions that lead to the emission of light.
Both substances remain stable, as long as a voltage is not applied.
The ECL reaction of ruthenium tris(bipyridyl)2+ and tripropylamine occurs at the
surface of a platinum electrode. The applied voltage creates an electrical field,
which causes all the materials in this field to react. Tripropylamine is oxidized at
the electrode, releases an electron and forms an intermediate tripropylamine
radical-cation, which further reacts by releasing a proton (H +) to form a TPA radical
(TPA•).
In turn, the ruthenium complex also releases an electron at the surface of the
electrode thus oxidizing to form the [Ru(bpy)33+] cation. This ruthenium cation is
the second reaction component for the following chemiluminescent reaction with
the TPA radical.

4-4 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
 4.1 ECL Technology

Electrode
surface +
TPA•
– +
e -H

TPA
TPA•
–
3+
e
Ru(bpy)3

– 2+
e Ru(bpy)
3
2+ excited
Ru(bpy) state
3
ground Photon
state (620nm)

The ECL reaction at the electrode surface

TPA• and Ru(bpy)33+ react with one another, whereby Ru(bpy) 33+ is reduced to
Ru(bpy)32+ and at the same time forms an excited state via energy transfer. This
excited state is unstable and decays with emission of a photon at
620 nm to its original state. The reaction cycle can now start again. The
tripropylamine radical reduces to by-products which do not affect the
chemiluminescent process. TPA is used up and therefore must be present in
excess. The reaction is controlled by diffusion of the TPA and the amount of
ruthenium complex present. As TPA in the electrical field is depleted, the signal
strength (light) is slowly reduced once the maximum is reached.
Although during measurement, TPA is used up, the ruthenium ground state
complex is continually regenerated. This means that the ruthenium complex can
perform many light-generating cycles during the measurement process, therefore
showing an inherent amplification effect which contributes to the technology’s
sensitivity. Many photons can be created from one antigen-antibody complex.

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 4-5
4.1 ECL Technology

ECL Signal Generation

The graph displays a typical ECL signal generation. Viewed from an electrical
perspective, the reaction can be explained as follows: When a voltage is applied
to the detection cell electrode, a peak of light emission occurs over a short time
interval and can be detected as the resulting ECL signal. A defined area under the
curve is measured around the intensity maximum.

ECL intensity (counts) applied voltage [mV]

1500

350,000
1200
300,000

250,000 900

200,000
600
150,000
300
100,000

50,000 0

0
0.00 0.20 0.40 0.60 0.80 1.00 1.20 time [sec.]

ECL signal generation

The dotted line indicates the voltage at the electrode used to generate the ECL
signal. The solid line is the actual light output measured by the photomultiplier
detector.

4-6 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
 4.1 ECL Technology

ECL Measuring Cell

The core of the system is the ECL detection cell, which is designed as a flow-
through cell. Essentially, three operating steps are performed in the measuring
cell:
• Bound/Free Separation
Using a magnet, the streptavidin microparticles that are coated with
antigen-antibody complexes, are uniformly deposited on the working
electrode. A system buffer (ProCell) is used to wash the particles on the
working electrode and to flush out the excess reagent and sample materials
from the measuring cell.
• ECL Reaction
The magnet is removed and a voltage is then applied to the electrode on
which the microparticles, coated with antigen-antibody complexes, are
deposited to initiate the ECL reaction. The light emission is measured with
a photomultiplier. The system then uses the corresponding signals for the
calculation of results.
• Release of Microparticles and Cell Cleaning
Once the measurement is completed, the paramagnetic microparticles are
washed away from the electrode surface with a special cleaning solution
(CleanCell). The surface of the measuring cell is regenerated by varying the
potential on the electrode. The cell is then ready for another measurement.

Magnetic microparticles Photomultiplier Counter electrode

with bound antigen-
antibody complex
Unbound label

Magnet
Working electrode Flow channel

ECL measuring cell

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 4-7
4.1 ECL Technology

Advantages of ECL Technology

Electrochemiluminescence is a highly innovative technology that offers distinct
advantages over other detection techniques.
• Extremely stable non-isotopic label allows liquid reagent convenience.
• Enhanced sensitivity in combination with short incubation times means high
quality assays and fast result turnaround.
• Large measuring range of five orders of magnitude minimizes dilutions and
repeats, reducing handling time and reagent costs.
• Applicable for the detection of all analytes providing a solid platform for
menu expansion.

Sandwich assay for high Bridge assay to determine

molecular weight analytes IgG and IgM

Competitive assay for low DNA/RNA probe assays

molecular weight haptens

surface magnetic analyte antibody

microparticle

Streptavidin-biotin
binding DNA probe ECL label

ECL assay types

4-8 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
Chapter 5
Test Principles

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 5-1
5.1 Competitive Test Principle

Introduction
Three test principles are available on the Elecsys 2010 Immunoassay System:
Competitive principle for extremely small analytes, sandwich principle (one or two
steps) for larger analytes and a bridging principle to detect antibodies in the
sample. A fourth method, for the detection of DNA/RNA molecules, is currently
under development.

Competitive Principle
This principle is applied to analytes of low molecular weight, such as FT3.
• In the first step, sample and a specific anti-T3 antibody labeled with a
ruthenium complex are combined in an assay cup.
• After addition of biotinylated T3 and streptavidin-coated paramagnetic
microparticles, the still free binding sites of the labeled antibody become
occupied, with formation of an antibody-hapten complex. The entire
complex is bound to the microparticle via interaction of biotin and
streptavidin.
• After the second incubation, the reaction mixture containing the immune
complexes is transported into the measuring cell. The immune complexes
are magnetically entrapped on the working electrode, but unbound reagent
and sample are washed away by ProCell.
• In the ECL reaction, the conjugate is a ruthenium based derivative and the
chemiluminescent reaction is electrically stimulated to produce light. The
amount of light produced is indirectly proportional to the amount of antigen
in the patient sample.
Evaluation and calculation of concentration of the antigen are carried out by
means of a calibration curve that was established using standards of known
antigen concentration.

5-2 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
 5.1 Competitive Test Principle

COMPETITION PRINCIPLE

FIRST REACTION

SECOND REACTION

LIGHT REACTION
SIGNAL (LIGHT)

TPA ➤ ECL
CONCENTRATION
MAGNETIC FORCE &
ELECTRICAL POTENTIAL

ANTIGEN RUTHENIUM
LABELED ANTIBODY TPA TRIPROPYLAMINE

BIOTINYLATED STREPTAVIDIN-COATED
ANTIGEN MICROPARTICLE

Competitive principle

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 5-3
5.2 Sandwich Test Principle

Sandwich Principle
The sandwich principle is applied to higher molecular weight analytes, such as
thyroid-stimulating hormone (TSH).
• In the first step, patient sample is combined with a reagent containing
biotinylated TSH antibody and a ruthenium-labeled TSH-specific antibody in
an assay cup. During a nine-minute incubation step, antibodies capture the
TSH present in the sample.
• In the second step, streptavidin-coated paramagnetic microparticles are
added. During a second nine-minute incubation, the biotinylated antibody
attaches to the streptavidin-coated surface of the microparticles.
• After the second incubation, the reaction mixture containing the immune
complexes is transported into the measuring cell; the immune complexes
are magnetically entrapped on the working electrode, but unbound reagent
and sample are washed away by ProCell.
• In the ECL reaction, the conjugate is a ruthenium based derivative and the
chemiluminescent reaction is electrically stimulated to produce light. The
amount of light produced is directly proportional to the amount of TSH in
the sample.
Evaluation and calculation of concentration of the antigen or analyte are carried
out by means of a calibration curve that was established using standards of
known antigen concentration.

5-4 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
 5.2 Sandwich Test Principle

SANDWICH PRINCIPLE

FIRST IMMUNOLOGICAL REACTION

SERUM CONSTITUENTS

SECOND REACTION

LIGHT REACTION
SIGNAL (LIGHT)

TPA ➤ ECL
CONCENTRATION
MAGNETIC FORCE &
ELECTRICAL POTENTIAL

ANTIGEN RUTHENIUM
LABELED ANTIBODY TPA TRIPROPYLAMINE

BIOTINYLATED STREPTAVIDIN-COATED
ANTIBODY MICROPARTICLE

Sandwich principle

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 5-5
5.3 Bridging Test Principle

Bridging Principle
The bridge principle is similar to the sandwich principle, except that the assay is
designed to detect antibodies, not antigens, (e.g., IgG, IgM and IgA). This is
accomplished by including biotinylated and ruthenium-labeled antigens in the
reagents for which the targeted antibody has affinity.
• In the first step, serum antibodies bind with the biotinylated and ruthenium-
labeled antigens to form an immune complex.
• The immune complex then reacts with streptavidin-coated microparticles
via the biotinylated antigen.
• After the second incubation, the reaction mixture containing the immune
complexes is transported into the measuring cell; the immune complexes
are magnetically entrapped on the working electrode, but unbound reagent
and sample are washed away by ProCell.
• In the ECL reaction, the conjugate is a ruthenium based derivative and the
chemiluminescent reaction is electrically stimulated to produce light. The
amount of light produced is directly proportional to the amount of analyte in
the sample.
Evaluation and calculation of the concentration of the antibody are carried out by
means of a calibration curve that was established using standards of known
antibody concentrations.

5-6 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
 5.3 Bridging Test Principle

BRIDGE PRINCIPLE

FIRST REACTION

SERUM
CONSTITUENTS

SECOND REACTION

LIGHT REACTION
SIGNAL (LIGHT)

TPA ➤ ECL

CONCENTRATION

MAGNETIC FORCE &

ELECTRICAL POTENTIAL

BIOTINYLIZED
ANTIGEN
SERUM
TPA TRIPROPYLAMINE

ANTIBODIES
RUTHENIUM STREPTAVIDIN-COATED
LABELED ANTIGEN MICROPARTICLES

Bridging principle

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 5-7
 Notes

5-8 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
Chapter 6
Calibration

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 6-1
6.1 Reagent Calibration

Introduction
Calibration is required to determine the concentration of an unknown substance
as accurately as possible independent of reagent lot, reagent conditions, and
analyzer conditions. For this, a master calibration curve is generated at
Boehringer Mannheim during production of the reagent that is encoded in the 2D
bar code of the appropriate reagent pack. This information is then transferred to
the analyzer. At the customer site, the analyzer generates an update of the master
curve by measuring two calibrators under routine laboratory conditions.

The calibration curve produced from the bar-coded master calibration and the
measured calibration is specific to each reagent lot and in some cases, to an
individual reagent pack. The result of a calibration is validated automatically by
the analyzer and can be further validated by the operator.

6-2 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
 6.1 Reagent Calibration

Master Calibration

Calibration concept of the Elecsys 2010

A reference standardization curve utilizing master test kit reagents and certified
reference standard material [e.g., World Health Organization (WHO) reference
material] is measured at Boehringer Mannheim. This curve uses 10 to 12 points.
The reference standard curve is the basis for the production of master calibrators.
A lot-specific master calibration curve (n=5 or 6) is measured at Boehringer
Mannheim using lot-specific test kit reagents and master calibrators. The shape
of the lot-specific master curve is characterized by a four parameter rodbard
function. The data characterizing this curve is stored in the lot-specific reagent
bar code. Lot-specific calibrator assigned values (i.e., CalSet assigned values) are
read off the lot-specific master calibration curve and are encoded in the CalSet
calibrator bar code card.
At the customer site, the calibration results from two calibrators that were
measured under routine conditions are mathematically combined with the
encoded data from the 2D bar code. From this combination, the Elecsys 2010
determines a lot calibration or reagent pack calibration from which the
concentration of measured samples is reliably calculated.

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 6-3
6.1 Reagent Calibration

Lot Calibration
A lot calibration (L-Cal) is a calibration performed with a fresh reagent pack that
has not been on the analyzer longer than 24 hours. Reagent-specific calibrators
are used to update two of the four rodbard curve defining parameters. This
adjusts the curve to match the original lot-specific calibration curve. The lot
calibration is valid for all other reagent packs of the same lot, provided these
reagent packs were stored as specified in the package insert or product
information sheet and not on the analyzer longer than 7 days.

Reagent Pack Calibration

A reagent pack calibration (R-Cal) is performed with a reagent that has been on the
analyzer more than 24 hours or is generated by an operator-released calibration. A
reagent pack calibration is valid for one specific reagent pack only. The reagent
pack calibration is compared to the most recent stored L-Cal for validation.

Calibration Stability
The stability of calibration is determined by two factors:
• the long term stability of the instrumentation
• the age of the reagent.
For many assays, a reagent pack will be used within seven days. In this situation,
it is not necessary to renew the calibration for the new reagent pack. In this case,
the lot calibration can be used for all other new reagent packs for a period as
recommended in the package insert (refer to the Calibration Frequency section).
After that period, a new lot calibration is recommended.
If the reagent is kept on the analyzer for more than seven days, it is recommended
to renew the calibration. This renewal of the calibration can be repeated as
needed until the on the analyzer expiration of the reagent (e.g., two months).

Calibration workflow on the Elecsys 2010

6-4 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
 6.1 Reagent Calibration

Calibration Validation
The calibration status of the test is easily identified on the CALIBRATION DATA
screen by the color of the test button. Three colors are used to distinguish
calibration status. They are as follows:
Green: Calibration was successful.
Yellow: Calibration was questionable. You must check the Calibration Data
report to determine which quality criteria were violated. You can
release this calibration by touching the test button, followed by the
l button. If a previous calibration exists, all sample and QC
results obtained prior to pressing l were calculated using the
last valid calibration. Review any QC with “Previous Calibration
Used” data alarms to determine if patient samples performed at the
same time as the yellow calibration may be acceptable.
After releasing the calibration, all subsequent results are calculated
using the released calibration. The released calibration is an R-Cal
(reagent pack calibration). Repeat QC values to determine the
validity of the released calibration.
If the calibration is discarded by touching m, the last valid
calibration is used to calculate subsequent sample results.
Red: Calibration failed. The last valid calibration is used to calculate the
sample results.
Preceding calibrations can only be used if a valid calibration exists in the software.
In the case of rejected questionable calibrations or failed calibrations, perform a
new calibration.

n
Follow your laboratory protocol regarding questionable or failed calibration
results.

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 6-5
6.1 Reagent Calibration

Calibration Quality Criteria

Each calibration is automatically validated by the instrument software according to
the following criteria.

Color Calibration Status Criteria

green successful • no values are missing
• all values are above the recommended minimum
signal level
• there are no duplicate errors
• calibration factor* is within acceptable range (0.6 - 1.4)
yellow questionable • one of either calibrator’s duplicate values is missing
• one of either calibrator’s duplicate values is below the
recommended minimum signal level
• one calibrator level was measured with a duplicate
error (i.e., the signal difference between the two
calibrator determinations is too high)
• the calibration factor is: 0.4 - 0.59 OR 1.41 - 1.6
red failed • two or more of the calibrator’s replicate values are
missing
• two or more of the calibrator’s replicate values are
below the recommended minimum signal level
• two calibrator levels were measured with a duplicate
error (i.e., the signal difference between the two
calibrator determinations is too high)
• calibration factor is out of range
(Cal factor < 0.4 OR Cal factor > 1.6)
• failure of monotony (e.g., measured calibrator values
were not in either ascending or descending order)

* Each lot calibration (L-Cal) utilizes a calibration factor of 1. For all

subsequent reagent pack calibrations (R-Cal), a new calibration factor is
calculated. This is done by relating the signal differences (between CalSet
high and CalSet low) of the new R-Cal to the corresponding signal
differences from the last valid L-Cal.

6-6 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
 6.2 Calibration of Quantitative Assays

Introduction
The following is a description of the different methods utilized by the Elecsys
2010 analyzer for calculating results. To calculate quantitative tests, the 2010
utilizes the following three calibration functions to convert measured signals into
concentrations:
• Rodbard function
• linear calibration function
• linear-reciprocal calibration function.
The calibration function used by the system is encoded in the 2-dimensional bar
code on the appropriate reagent pack. The calculations are performed
automatically by the analyzer, including the correction for samples diluted by the
analyzer.

Rodbard Function
The conversion of the measured signal into a concentration using the Rodbard
function is as follows:

a-d x = Sample concentration

y= +d
1+
x c
b ( ) a, b, c, d = Rodbard function parameters
y = Signal

Parameters b and c define the shape of the curve and parameters a and d define
the position of the curve.
Under the controlled conditions of automation on the analyzer, the shape of the
calibration curve is very stable and, therefore, it is possible to calibrate this
nonlinear function with only two calibrators and the information of the shape
parameters b and c. The curve position parameters a and d are calculated with
each calibration. Such a calibration is called 2-point calibration.
The following inverse formula is used to determine the unknown’s concentration
based on its signal.

y = Signal
/C
( )
1
a-y a, b, c, d = Rodbard function parameter
x=b• y-d
x = Sample concentration

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 6-7
6.2 Calibration of Quantitative Assays

Linear Calibration Function

The conversion of the measured signal into a concentration is as follows:

y = Signal

y=b•x+a x = Concentration

a, b = Calibration curve parameter (y-

intercept and slope)
Calibrations using a linear calibration curve are always performed using two
calibrators.
The following inverse formula is used to determine the unknown’s concentration
based on its signal.
x = Sample concentration
y-a
x= a, b = Calibration curve parameter
b
y = Signal

Linear Reciprocal Calibration Function

The conversion of the measured signal into a concentration is as follows:

y = Signal
1
=b•x+a x = Concentration
y
a, b = Calibration curve parameter (y-
intercept and slope)
Calibrations using a linear reciprocal calibration curve are always performed using
two calibrators.
The following inverse formula is used to determine the unknown’s concentration
based on its signal.
x = Sample concentration
1 - ay
x= a, b = Calibration curve parameter
by
y = Signal

6-8 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
 6.3 Calibration of Qualitative Assays

Calibration of Qualitative Assays

For qualitative tests (cut-off tests), a cut-off value is established. Using this cut-
off, patient samples can be assessed as reactive, non-reactive or borderline.
For calibration, two calibrators [reactive (REAC) and non-reactive (N-REAC)] are
used. The calibrators produce effective signals from which the cut-off value can
be calculated as follows:
SCut-off = Cut-off
SPOS = Effective signal of the reactive
calibrator
SCut-off = (A•SNEG) + (B•SPOS) + C
SNEG = Effective signal of the non-
reactive calibrator
A, B, C = Assay specific cut-off
parameters (according to the
2D bar code)
A cut-off index is calculated from both calibrators.

Cut-offIndexNEG = Cut-off index of the non-reactive

calibrator
SNEG Cut-offIndexPOS = Cut-off index of the reactive
Cut-OffIndexNEG =
S Cut-off calibrator
SNEG = Effective signal of the non-reactive
calibrator

SPOS SPOS = Effective signal of the reactive

Cut-OffIndexPOS = calibrator
S Cut-off
SCut-off = Cut-off of the calibrator
Both the REAC and N-REAC cut-off indices are used to check the quality of the
calibration.
The calibration status is made up of the following parameters:
• Cut-off SCut-off
• Cut-off indices of both REAC and N-REAC calibrators.
Calibrations for qualitative tests are always performed using both reactive and
non-reactive calibrators.

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6.3 Calibration of Qualitative Assays

Result Calculation for Qualitative Assays

To calculate the qualitative test (cut-off tests) the 2010 compares the effective
signal with a cut-off signal that was measured during calibration. Defined limit
values are contained in the 2D bar code.
The cut-off index required to evaluate the test result compares the behavior of the
sample signal to the cut-off signal.
Cut-Off Index = Cut-off index
S eff
Cut-OffIndex = Seff = Effective signal of the sample
SCut-off measurement
SCutOff = Cut-off signal of the calibration
Sandwich tests exhibit a positive slope, for competitive tests the slope is negative.
Result output is as follows:
reactive: if the result for a positive curve slope is greater than or equal to the
upper limit of the defined cut-off index;
or, if the result for a negative curve slope is less than or equal to the
lower limit of the defined cut-off index.
non-reactive: if the result for a positive curve slope is less than the lower limit of
the defined cut-off index;
or, if the result for a negative curve slope is greater than the upper
limit of the defined cut-off index.
borderline: if the result for a positive curve slope is greater than or equal to the
lower limit and less than the upper limit of the defined cut-off index;
or, if the result for a negative curve slope is less than the upper limit
and greater than the lower limit of the defined cut-off index.

Cut-Off Index Slope Result Flag/Output

x < LL + non-reactive n-reac.
LL ­ x < UL + borderline border
UL ­ x + reactive reac.
x ­ LL - reactive reac.
LL < x ­ UL - borderline border
UL < x - non-reactive n-reac.

x = Cut-Off Index
LL = Lower limit of the Cut-Off Index
UL = Upper limit of the Cut-Off Index

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 Glossary

Glossary

Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0 G-1
Glossary

Numbers
2-dimensional bar code (2D) type of bar code found on the reagent pack, calibrator
and control bar code cards. Utilizes PDF417 symbology.
This bar code contains more information than traditional
linear bar codes.

A
A-Line the unit of the rack sampler where you load the tray and
sample racks.
analytical sensitivity the lower detection limit of the assay. The analytical
sensitivity represents the lowest analyte concentration that
can be distinguished from zero. It is calculated as the
concentration two standard deviations above the lowest
standard used in the master calibration. Since the master
calibration is performed by Boehringer Mannheim, it is not
possible for the customer to verify the sensitivity exactly as
it was performed at Boehringer Mannheim. CalSet vial 1
was not used to determine analytical sensitivity. Master
calibration standards were used.
analyzer unit the analyzer unit consists of the sample/reagent area,
consumables area, measuring area and power switch.
aspiration station position located next to the incubator where the assay cup
containing reaction mixture is placed for aspiration into the
measuring cell by the sipper probe.
assay • a specific test.
• the process of measuring a substance.
assay cup (or cup) clear plastic cup that is used to hold the assay reaction
mixture. Cups are configured in trays that contain 60 cups
each.
assay tip (or tip) disposable pipette tip made of black, conductive plastic.
Assay tips are used by the sample/reagent (S/R) probe.
Tips are configured in trays that contain 120 tips each.
assigned values the assigned value for a calibrator (Cal 1 or Cal 2) is
encoded on the calibrator bar code card.

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 Glossary

B
B-Line transports sample racks, single file, first to the rack bar
code reader and then to the sampling position.
bar code a series of lines representing data encoded in a format
containing information that can be automatically scanned.
Bar codes used on the analyzer can either be linear or 2D.
bar code card either a calibrator or control card. These cards contain
either all assigned values (calibrator card) or target values
and ranges (control card) for assays.
bar code card slot located between the sample disk and the reagent
reading station disk where the calibrator or control bar code cards are
scanned.
bar code card slot located to the back left of the reagent disk where the
reading station calibrator or control bar code cards are scanned.
bar code reader the device that reads the code from a sample, reagent bar
code label or bar code card.
bar code scan process to read the bar code information into instrument
memory. Three are possible: reagent scan, sample scan
(disk system only) and bar code card scan.
BC card scan a scan to read the information from the 2D calibrator bar
code card or control bar code card.
BlankCell reagent pack used to perform an initial BlankCell procedure.
This procedure is primarily done by BM Service.
block a result can be blocked by the operator (B) or the system
(S). A blocked result is printed or uploaded to the host with
the appropriate flag (i.e., “B” or “S”). Block a result that is
questionable and that should be repeated.
bottle set 1 the set of ProCell/CleanCell that occupies positions 1 and 2
in the system reagent compartment.
bottle set 2 the set of ProCell/CleanCell that occupies positions 3 and 4
in the system reagent compartment. When starting from
Stand-by, the analyzer always accesses bottle set 2 first.
bound/free separation the physical separation of reagent and/or sample which is
bound to a solid phase (i.e., microparticles) from free
reagent and/or sample. This step occurs in the measuring
cell.

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Glossary
bridging principle one of three test principles available on the 2010 analyzer.
It is used to detect antibodies in the sample (e.g., IgG, IgM
or IgA).
button buttons are found on the screen or pop-up window. They
can be touched to either initiate an action or move to a
different screen. Buttons found on a screen are “screen
buttons” and buttons found on a pop-up window are
“window buttons.”

C
C-Line receives racks from the B-Line. It holds a maximum of 15
racks at a time.
calibration the process to standardize the instrument with samples of
known concentration. This process establishes factors and
or updates baselines to enable conversion of the response
of the instrument to concentration (or activity) for the
constituent being measured.
calibration factor one of the six calibration quality criteria used to determine
the outcome of a calibration. It is derived by the
comparison of two different calibrations. A factor of 1.0 is
produced if the two calibration are perfectly matched. Each
R-Cal is compared to the L-Cal to generate this factor. A
successful calibration should have a factor of 0.6 - 1.4. The
remaining criteria are missing values, monotony of curve,
minimum signal, deviation of duplicate measurements and
system errors.
calibration frequency the specified interval at which an assay must be calibrated.
This frequency is found in reagent package inserts.
calibration function the type of calibration (e.g., Rodbard function, linear
function, cutoff function).
calibration quality criteria criteria applied to the automatic validation of every
calibration on the analyzer.
calibration type Lot calibration (L-Cal) or Reagent pack calibration (R-Cal)
calibration validation procedure performed by the analyzer software whereby a
calibration data set is checked versus specific criteria
encoded in the reagent bar code. The conclusion of a
validation is a green (successful), yellow (questionable) or
red (failed) calibration.

G-4 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
 Glossary
calibration verification a procedure required by HCFA and CLIA. “Calibration
verification is the assaying of calibration materials in the
same manner as patient samples to confirm that the
calibration of the instrument kit or test system has remained
stable throughout the laboratory’s reportable range for
patient test results.”1
calibrator a substance with known concentrations used in the
calibration of immunoassays.
capacitance used in liquid level detection in the S/R probe and sipper
probes. The probes carry a high frequency low voltage
electrical charge. The frequency and electrical charge
characteristics are altered and sensed when the probe
touches liquid.
CapTwist opener to aid in the manual removal of ProCell and
CleanCell bottle caps.
circuit breaker found on the lower right side of the analyzer. It controls
power to the peltiers, thereby controlling the temperature in
the reagent disk, incubator, system reagent compartment
and measuring cell.
CleanCell reagent used to:
• cleanse the tubing system and measuring cell after each
measurement
• condition the electrodes.
Clean-Liner disposable liner used in the solid waste tray. Clean-Liner
has a sliding lid that can be closed to prevent spillage of
potentially biohazardous material from used tips and cups.
clot detection used in the aspiration systems of the S/R probe and sipper
probe. As the appropriate volume of sample is aspirated,
the release of vacuum is monitored by a vacuum/pressure
transducer. If an abnormal vacuum is detected, a clot
detection alarm is issued to notify you and the sample is not
aspirated.
competitive principle one of three test principles available on the 2010 analyzer.
It is used to detect analytes of low molecular weight (e.g.,
FT3).
compl a sample status found on the STATUS screen. Pipetting is
complete and the sample can be removed from the rack on
the C-Line.
1. 42 United States Code of Federal Regulations. Part 493.1217. Standard; Calibration and calibration
verification procedures.

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Glossary
consumables items that are used during test processing and must be
replaced on a regular basis by the operator (i.e., assay cups
and tips, printer paper, etc.).
consumables area consists of three assay cup trays, three tip trays, gripper,
incubator, cup disposal opening, pipetting station, liquid
waste container, distilled water container and solid waste
tray and liner.
continuous access ability of the operator to access the sample disk to load
samples at any time during operation or to place racks on
the A-Line at any time during operation.
control (or quality control) a substance with known values of analytes used to verify
calibration and performance of immunoassays.
control ID the abbreviated control name found in the software (e.g., PC
U1 or PC TSH)
control name the name of a control (e.g., PreciControl Universal).
control unit the part of hardware that consists of the touchscreen
monitor, keyboard and floppy disk drive.
cup See assay cup.
cup disposal opening opening to the left of the incubator where used assay cups
are disposed into the solid waste tray.
cycle instrument time interval of 42 seconds.

D
data disk contains files necessary for the analyzer and the software to
work together. These files include:
• analyzer specific adjustment files
• assay reference tables
• calibration data
• up to 400 orders and test results.
data entry field a field on the software screen where you can enter or edit
information. This field is touch-activated.
data field a field on the software screen that contains information only.
There is no user access. This field cannot be activated.
detection unit contains the photomultiplier tube, peltier, flow-through
measuring cell, magnet drive assembly and an amplifier
circuit board. The detection unit is the core of the 2010

G-6 Boehringer Mannheim Elecsys® 2010 Immunoassay System Reference Guide V 2.0
 Glossary
analyzer.
deviation of duplicate one of the six calibration quality criteria. For a calibration to
measurements be successful, replicate measurements must fall within a
specific duplicate limit. The remaining criteria are missing
values, monotony of curve, calibration factor, minimum
signal and system errors.
diluent See Universal diluent.
dilution factor a software preset dilution ratio that is used by the analyzer
to automatically perform a requested dilution. Dilutions may
be 1:2, 1:5, 1:10, 1:20, 1:50 and 1:100. Recommended
dilution factors are found in reagent package inserts and in
product informations.
disk position a position on either the sample or reagent disk. There are
up to 30 sample disk positions. There are up to 18 reagent
disk positions.
dispense delivery of a sample or reagent by the appropriate probe to
an assay cup.
distilled water container contains the distilled or deionized water supply for the
analyzer. The three liter plastic bottle is located in front of
the pipettors and to the right of the liquid waste container.
document the process of printing a report for a sample which in turn
transfers the sample results to the RESULTS screen.
door See front access panel.
download the transfer of information (e.g., sample ID, test requests)
from the host computer system to the 2010 analyzer.
DNA/RNA probe a test principle that can be used on the 2010 analyzer. The
DNA/RNA probe is for the detection of DNA or RNA
molecules and is currently under development.

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Glossary

E
ECL electrochemiluminescence. The detection technology used
on Elecsys immunoassay analyzers.
empty a sample status found on the STATUS screen. An empty
sample disk or rack position exists.
error handling process during which the analyzer attempts to recover from
an error condition (e.g., a tip was not picked up from a tray).
If the analyzer cannot successfully recover from the error, an
alarm is issued.
expected values the values for an assay that should be recovered for a
“normal” result. Also known as normal range or reference
range.
extended dynamic range the measuring range for an assay at its highest dilution.

F
first registration date the date that the reagent pack was first successfully
scanned by the bar code reader. This date is found in the
assay ‘Reagent Details’ pop-up window.
flag an identifier used to call attention to a result. A data flag
could be “S” (blocked by the system), “B” (blocked by the
operator) or “R” (released by the operator). Flags are seen
in conjunction with data alarms.
floppy disk (FD) a small plastic disk coated with magnetic material on
which data from a computer can be stored.
floppy disk drive holds the data disk required for operation. The drive is
located behind the front access door above the solid waste
tray.
front access panel (or door) door behind which the floppy disk drive and solid waste tray
reside.
functional sensitivity concentration at which a particular level of imprecision is
obtained.

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 Glossary

G
global action keys keys that are found on the keyboard that remain active on
all screens. These buttons include:
Q, S, R, T,
A and d.
gripper a unit that moves in three directions (X, Y and Z). It is
equipped with a mechanism that picks up tips or cups from
the tray. The gripper picks up tips/cups and transports
them to/from the incubator, aspiration station or cup
disposal opening.

H
host communication information exchange with a laboratory information system
(host computer).

I
incubator an aluminum block maintained at 37 °C that accommodates
32 assay cups containing reaction mixture.
Initial BlankCell procedure procedure performed by BM Service and utilized to maintain
the sensitivity of the measuring cell and photomultiplier
tube.
input buffer the buffer zone between the A-Line and the B-Line. It holds
a maximum of 5 racks.
instrument alarms displayed alarms that indicate abnormal instrument
conditions (i.e., reagent disk temperature, mechanical
malfunctions, etc.).
inventory control real time monitoring of the actual amount of all consumable
items on the analyzer.

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Glossary

L
Laboratory Information (LIS) external computer with appropriate software for data
System management (host computer)
Laboratory System (LSM) a common user interface for patient administration,
Manager sample ordering, validation and quality control in clinical
chemistry and iummunology.
linear bar code a traditional 1D bar code. It has limited data capacity.
liquid level detection (LLD) ability of the sample/reagent and sipper probes to
sense liquid.
liquid waste container contains liquid waste generated by the analyzer. The four
liter plastic bottle is located in the front of the ProCell and
CleanCell reagent compartments.
lot calibration (L-Cal) a calibration performed with a fresh reagent pack
that has been on the analyzer less than 24 hours. The lot
calibration is valid for all other reagent packs of the same
lot, provided these reagent packs were stored as specified
in the package insert and not on the analyzer longer than
seven days.
lower detection limit (LDL) See analytical sensitivity.

M
master calibration A reference standardization curve utilizing master test kit
reagents and certified reference standard material [e.g.,
World Health Organization (WHO) reference material]
measured at Boehringer Mannheim. This curve uses 10 to
12 points. The reference standard curve is the basis for the
production of master calibrators.
master curve A lot-specific master calibration curve (n=5 or 6) measured
at Boehringer Mannheim using lot-specific test kit reagents
and master calibrators. The shape of the lot-specific master
curve is characterized by a four parameter rodbard function.
The data characterizing this curve is stored in the lot-
specific reagent bar code. Lot-specific calibrator assigned
values (i.e., CalSet assigned values) are read from the lot-
specific master calibration curve and encoded in the CalSet
calibrator bar code card.
Material Safety Data (MSDS) documents that list components of chemical
Sheets solutions and precautions for the handling and disposal of
the solutions.

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 Glossary
mean the average value of a set of numbers, used in quality
control evaluations.
measuring cell flow-through cell where result measurement takes place.
The measuring cell is part of the detection unit.
measuring range See reportable range.
microparticle paramagnetic streptavidin-coated microparticles are the
solid phase used in the bound/free separation step of ECL.
microparticle mixer paddle on the sample/reagent arm that thoroughly mixes the
microparticle reagent to ensure resuspension prior to use.
minimum signal one of the six calibration quality criteria. Each calibrator
replicate value must be greater than a designated minimum
signal value for a successful calibration. The remaining
criteria are missing values, monotony of curve, calibration
factor, deviation of duplicate measurements and system
errors.
missing value one of the six calibration quality criteria. No calibrator
replicates may be missing for a successful calibration. The
remaining criteria are monotony of curve, calibration factor,
minimum signal, deviation of duplicate measurements and
system errors.
monotony of curve one of the six calibration quality criteria. All measured
calibrator values must fall in either ascending (sandwich or
bridging principle) or descending (competition principle)
order for a successful calibration. The remaining criteria are
missing values, calibration factor, minimum signal, deviation
of duplicate measurements and system errors.

N
note a statement in the text called out to make the operator
aware of specific information.
normal range See expected values.

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Glossary

O
occup a sample status found on the STATUS screen. The sample
disk position or rack position is occupied.
open request orders for a sample that have not yet been performed.
operation an instrument status condition that occurs when the
analyzer is performing its routine operations.
operation ON/OFF switch found on the front left of the analyzer. This switch is used to
turn the analyzer ON or OFF.
operator ID a number used to identify different operators.
order (or request) tests selected for a specific sample or control.
output buffer the buffer zone between the B-Line and the C-Line. It holds
a maximum of 5 racks.

P
paramagnetic used in reference to microparticles. Microparticles
themselves do not exhibit magnetic properties, but are
capable of becoming magnetic when in the presence of a
magnet or magnetic field.
parameters a set of criteria used to establish how an assay is
performed. All parameters are encoded on the reagent bar
code label and cannot be changed by the operator.
pending requests partial results for a sample are available; while other tests
have not yet been performed or completed.
photomultiplier a photoemissive photoelectric tube that amplifies emitted
photons from the ECL reaction and converts them into an
electric signal.
photon a quantum of electromagnetic energy having both particle
and wave behavior. It has no charge or mass, but
possesses momentum; it carries the light emitted from the
ECL reaction.
pipetting station located to the upper left of the incubator. Cups and tips are
moved by the gripper to this location for sample and
reagent pipetting, sample dilution or sample pretreatment.
pop-up window a window containing additional information that “pops up”
within existing screens. It may appear as a result of
touching a button on a screen.

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 Glossary
positive displacement water in the pipettor that is displaced by the plunger during
an aspirate/dispense cycle. Is equal to the amount of
sample/reagent that is aspirated/dispensed by the probe.
ProCell reagent used to:
• condition the electrode
• transport the assay reaction mixture
• wash the streptavidin-coated microparticles
• generate signal.

Q
qualitative assay a determination of a substance without regard to quantity.
quality control See control.
quantitative assay a determination of a substance with regard to a specified
number or amount.
questionable calibration a calibration that does not successfully pass the calibration
quality criteria. The curve may be manually released or
rejected by the operator.

R
rack a device that holds sample cups or primary sample tubes.
Each rack holds a maximum of five samples. Racks are
transported on the lines of the rack sampler.
rack bar code auto-discriminating reader that reads both sample bar code
reader labels and the rack ID bar code.
rack circuit located on the left side of the rack sampler. It controls
breaker power to the rack sampler unit. It should be left ON.
rack ID the bar code on the end of the rack that identifies the rack
for positive sample ID.
rack pusher arm arms located on the A-Line, B-Line and C-Line. They push
the racks along the respective line.
rack sampler unit consisting of an A-Line for rack input, B-Line for
transport and sampling and a C-Line for rack receipt.
reaction mixture sample combined with reagents in the assay cup. This final
mixture is aspirated into the measuring cell.

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Glossary
reagent cap open/close a mechanism that automatically opens and closes the
mechanism reagent caps before and after reagent pipetting. This
controls reagent evaporation.
reagent disk disk where reagent packs are located while on the analyzer.
The disk contains 18 total positions.
reagent disk cover the cover that closes the reagent disk compartment. This
cover assists in controlling the temperature of the reagent
disk.
reagent disk position one of 18 positions on the reagent disk. Its presence is
monitored by a sensor.
reagent pack reagent used on the Elecsys analyzer. It is composed of
three physically connected bottles (R1, R2 and
Microparticles). The components of a reagent pack cannot
be interchanged with another reagent pack.
reagent pack calibration (R-Cal) a reagent pack calibration is performed when
reagent has been on board the analyzer more than 24 hours
or when generated by an operator-released calibration. A
reagent pack calibration is valid for one specific reagent
pack only. The reagent pack calibration is compared to the
most recent stored L-Cal for validation.
reagent pack number the unique number on the reagent bottle label that identifies
each reagent pack.
reagent scan a scan of the reagent disk to read information from the 2D
reagent bar code into the analyzer and update inventory.
real time display of information on the monitor at the moment a
change altering such information occurs.
regst a sample status found on the STATUS screen. The disk
position contains a sample that was programmed or read by
the bar code reader.
remov a sample status found on the STATUS screen. Sample
pipetting is complete and the sample can be removed from
the disk or rack.
renewed calibration a calibration that is performed when the assay specific time
has expired. Refer to the Calibrators section of the package
insert or product information for the assay specific time.
reportable range the range of which results can be reported for the assay. It
is from the lower detection limit to the maximum of the
master calibration curve.

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 Glossary
request (or order) tests selected for a specific sample or control.
result signal converted into concentration for the assay selected.
A result is generated for each test performed.
rinse station rinses the assay tip, mixer or probe externally with
deionized water. A separate rinse station exists for the
sample/reagent probe and mixer, and for the sipper probe.
rodbard function a calibration function used by the analyzer to convert
measured signals into concentrations. It utilizes four
parameters; two of which define the shape of the curve and
the other two define the position of curve.
ruthenium a rare metallic chemical element of the platinum group that
is utilized in electrochemiluminescent reactions.
ruthenium complex [Ru(byp)32+] N-hydroxysuccinimide (NHS) ester. The
complex is used for the development of light in ECL
reactions.

S
sample disk has 30 positions for samples, calibrator and controls. Built
in adapters allow intermixing of different size primary
sample tubes.
sample disk position one of 30 available positions on the sample disk.
sample ID the identifier for the sample. It may be up to 22 characters
(alphanumeric).
sample rack See rack.
Sample/Reagent arm (S/R arm) the horizontal moving arm that holds the sample/
reagent probe and microparticle mixer.
Sample/Reagent pipettor (S/R pipettor) located on the back right of the analyzer. It is
filled with deionized water and uses positive displacement
to aspirate and dispense from the sample/reagent probe.
Sample/Reagent probe (S/R probe) mounted on the sample/reagent arm, it uses
disposable tips to control carryover, and has liquid level and
clot detection for accurate pipetting.
sample scan a scan of the sample disk to read the information from the
primary sample tubes into the analyzer to update the
ORDERS screen.

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Glossary
sandwich principle one of three test principles available on the 2010 analyzer.
It is used to detect higher molecular weight analytes (e.g.,
TSH).
scan See bar code scan.
screen button a button in the software that is found on a screen (e.g.,
ORDERS, MAINTENANCE).
SD standard deviation, statistic used as a measure of the
dispersion or variation in a distribution, equal to the square
root of the arithmetic mean of the squares of the deviations
from the arithmetic mean.
select to mark an item so that a subsequent action can be
performed on that item. An item is selected by touching it
on the screen.
sequence number a number from 1 to 9999. This number is automatically
assigned to each sample by the analyzer and is used to
track orders.
signal the emission of light converted into an electric signal, which
is in turn converted into an analyte concentration.
sipper arm horizontally moving arm that holds the sipper probe.
sipper probe probe that aspirates reaction mixture into the measuring
cell. This probe also aspirates ProCell and CleanCell.
sipper pipettor located directly to the right of the sample/reagent pipettor.
It is filled with deionized water and uses positive
displacement to aspirate and dispense from the sipper
probe.
smpl a sample status found on the STATUS screen. The sample
either currently being pipetted or preparing to be pipetted.
solid waste tray metal waste container holding a liner (Clean-Liner) located
behind the front access door. Used cups and tips are
discarded here during operation.
S/R arm See sample/reagent arm.
S/R pipettor See sample/reagent pipettor.
standard traceable reference material solutions used to create the
master calibration curve.
Stand-by status condition that exists when the analyzer is not
performing any operations.

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 Glossary
STAT position located at the front of the analyzer. It is an extension of the
B-Line. A rack placed here is sampled after the current rack
is finished.
STAT sample (Short Turn Around Time) a sample that requires rapid
turnaround. Designated by a yellow button on the STATUS
screen.
status • one of many instrument status conditions
• one of six sample statuses (i.e., empty, regst, occup,
smpl, remov and compl).
status line line at the top of the touchscreen that displays the operator
ID, system status (i.e., current operating conditions) and
actual time. If an alarm occurs, the line changes color
depending upon the severity of the alarm.
system errors one of the six calibration quality criteria. A hardware error
occurred during a calibrator measurement. The remaining
criteria are monotony of curve, calibration factor, minimum
signal, missing values and deviation of duplicate
measurements.

T
target range the specified limits of a control range for an assay.
target value the mean value of the control target range for the assay.
temperature controlled the temperature in a compartment is held stable within a
specified range. The temperature is controlled with peltier
units.
test See assay.
test code the abbreviated name for a test. This code appears on the
test buttons within the software.
test principle one of three principles used to detect analytes on the
analyzer. These include competition, sandwich and
bridging.
test protocol an exact sequence of test steps used to perform an assay.
These test steps include pipetting sample, reagent,
incubating the reaction mixture for a specified time, etc.
tip See assay tip.
tip eject station position 6 on the pipetting station. This is where the assay
tips are ejected from the sample/reagent probe.

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Glossary
touchscreen LCD screen located on the left side of the analyzer that
displays the software. Certain actions are performed by
touching buttons on the screen.
tray a device that holds a maximum of 15 sample racks. Trays
are placed on the A-LIne or C-Line.
tray indication light a light at the left side of both the A-Line and C-Line. When
the light is green, you can add racks or a new tray to the A-
Line, or remove a tray from the C-LIne. If red, the pusher
arm is about to move; do not remove a tray.
tripropylamine (TPA) one of two electrochemically active substances used
in the ECL reaction. TPA acts with the ruthenium complex
to initiate the light generating cycle, which results in the
emission of a photon.

U
unit of measure assays are measured in certain concentration units. The
analyzer has designated units of measure for the analytes;
this information is contained in the reagent bar code.
universal diluent reagent used to dilute samples that exceed the reportable
range of the assay.
upload the sending of information (e.g., sample ID, test results, etc.)
from the analyzer to the host computer.

W
warning a statement called out in this manual to make the operator
aware of conditions that could cause damage to the
analyzer or could cause personal injury.
waste anything discarded by the analyzer. It could be liquid waste
or solid waste (tips and cups).
window button a button on the software that is found on a pop-up window
(e.g. ‘Reagent Details’ or ‘System Reset’).
work list a report generated from the ORDERS screen. It lists
calibrators, controls and samples currently loaded on the
sample disk, or programmed on sample racks, as well as
the tests selected.

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