Acetaminophen (ACET)

Current Revision and Datea Rev. H, 2020-02

Product Name ADVIA® Chemistry Acetaminophen (ACET) Reagents REF 07989138

Systems ADVIA 1800 Chemistry System

ADVIA 2400 Chemistry System

Materials Required but Not Provided Siemens ToxAmmonia Calibrator REF 06549444
Reagent container adapters
Commercially available controls

Specimen Types Human serum, plasma (lithium heparin)

Assay Principle Enzymatic

Assay Range Serum: 0.2–20.0 mg/dL (13.2–1322 μmol/L)

Plasma: 0.2–20.0 mg/dL (13.2–1322 μmol/L)

Reagent Storage 2–8°C

Reagent On‑System Stability 10 days when you are not using a reagent container insert
28 days when you are using a reagent container insert

Reagent Code 74363

a In Rev. G or later, a vertical bar in the margin indicates a technical update to the previous version.

Intended Use
For in vitro diagnostic use in the quantitative determination of acetaminophen in human
serum and plasma (lithium heparin) on ADVIA® Chemistry systems. Such measurements are
used in the detection of acetaminophen overdose.

Summary and Explanation

Acetaminophen (paracetamol) is used as an analgesic in many different formulations.1 While
therapeutic doses rarely cause adverse side effects, the effect of long-term treatment with
acetaminophen is unclear. Cases have been reported where chronic excessive use of
acetaminophen has led to hepatotoxicity and nephrotoxicity.2,3 In case of acute overdosage,
acetaminophen can cause severe hepatic damage leading to hepatic failure if untreated.4,5,6

Principles of the Procedure

The ADVIA Chemistry Acetaminophen (ACET) assay is based on the conversion of
acetaminophen by acyl amidohydrolase to produce p‑aminophenol. The p‑aminophenol is
then converted to a colored complex produced by reacting with 8‑hydroxyquinoline‑5‑sulfonic
acid.7,8

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The enzyme, acyl amidohydrolase, cleaves the amide bond of the acetaminophen molecule,
leaving p‑aminophenol and acetate. The p‑aminophenol reacts with
8‑hydroxoquinoline‑5‑sulfonic acid in the presence of manganese ions to form a colored
compound 5‑(4‑iminophenol)‑8‑quinoline. The increased absorbance at 596/751 nm is
directly proportional to the concentration of acetaminophen in the sample.

Reaction Equation
Acylamidohydrolase
Acetaminophen p‑Aminophenol

p‑Aminophenol + 8-Hydroxyquinoline- 5-
Mn2+ 5-(4-Iminophenol)-8-Quinoline
Sulfonic Acid

Reagents
Reagent Description Storage Reagent Stability

REF 07989138 ADVIA Chemistry Acetaminophen (ACET) Reagents

Acetaminophen 10.3 mL in 20‑mL containers 2–8°C Unopened: Stable until the expiration date
Reagent 1 Buffer, pH 8.6 on product.
Manganese Chloride On‑system:
(0.2 mmol/L) • 10 days when you are not using a
Acyl Amidohydroxylase reagent container insert.
(≥ 0.9 kU/L) • 28 days when you are using a reagent
NaN3 (0.005%) container insert

Acetaminophen 10.3 mL in 20‑mL containers 2–8°C Unopened: Stable until the expiration date
Reagent 2 Sodium Carbonate buffer, on product.
pH 12.2 On‑system:
8-Hydroxyquinoline-5-sulfonic • 10 days when you are not using a
acid (30 mmol/L) reagent container insert.
• 28 days when you are using a reagent
container insert

Warnings and Precautions

Safety data sheets (MSDS/SDS) available on siemens.com/healthcare.
Contains sodium azide as a preservative. Sodium azide can react with copper or lead plumbing
to form explosive metal azides. On disposal, flush reagents with a large volume of water to
prevent the buildup of azides. Disposal into drain systems must be in compliance with
prevailing regulatory requirements.
Dispose of hazardous or biologically contaminated materials according to the practices of your
institution. Discard all materials in a safe and acceptable manner, and in compliance with
prevailing regulatory requirements.
Caution: Federal (USA) law restricts this device to sale by or on the order of a licensed
healthcare professional.
For in vitro diagnostic use.

Preparing Reagents
All reagents are liquid and ready to use.
Before use, gently invert the capped reagent to disrupt bubbles and ensure homogeneity. If
bubbles still exist or foam is present, use a clean transfer pipette to aspirate them from the
reagent container prior to use.

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Storing and Stability

Unopened reagents are stable until the expiration date printed on the product label when
stored at 2–8°C. Do not freeze reagents.

Specimen Collection and Handling

Siemens Healthcare Diagnostics validated serum and plasma (lithium heparin) for the
ADVIA Chemistry ACET assay.
Follow these guidelines for specimens used for this assay:
• Serum and plasma can be collected using recommended procedures for collection of
diagnostic blood specimens by venipuncture.9 Follow the instructions provided with your
specimen collection device for use and processing.10
• Complete clot formation should take place before centrifugation.
• Serum or plasma should be physically separated from cells as soon as possible with a
maximum limit of 2 hours from the time of collection.11
• Specimens should be free of particulate matter.
• Specimens should be as fresh as possible.
The purpose of handling and storage information is to provide guidance to users. It is the
responsibility of the individual laboratory to use all available references and/or its own studies
when establishing alternate stability criteria to meet specific needs.

Procedure
Materials Provided
The following materials are provided:

Item Contents Number of Tests

REF 07989138 Reagent 1: 4 × 20‑mL containers 4 × 150

Reagent 2: 4 × 20‑mL containers

Materials Required but Not Provided

The following materials are required to perform this assay, but are not provided:

Item Description

REF 06549444 Siemens ToxAmmonia Calibrator

REF 02404085 20-mL reagent container adapter for 40-mL slot (ADVIA 1800)

REF 00771668 20‑mL reagent container adapter for 70‑mL slot (ADVIA 2400)

Commercially available control materials

Optional Materials
The following materials may be used to perform this assay, but are not provided:

Item Description

REF 02991886 Reagent container insert

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Assay Procedure
Sampling, reagent delivery, mixing, and processing are automatically performed by the
ADVIA Chemistry system.
For detailed information on performing the procedure, refer to the system operating
instructions.

Preparing the System

For detailed information on preparing the system, refer to the system operating instructions.

Preparing the Samples

Before placing samples on the system, ensure that samples have the following characteristics:
• Samples are free of fibrin or other particulate matter.
• Samples are free of bubbles.

On-System Stability
The ADVIA Chemistry ACET reagents are stable on the system for 10 days when you are not
using a reagent container insert, and for 28 days when you are using a reagent container
insert.
Do not use reagents beyond the expiration date.

Performing Calibration
To calibrate the ADVIA Chemistry ACET assay, use the Siemens ToxAmmonia Calibrator
(REF 06549444).
Enter the lot-specific calibrator values that are provided with each lot of calibrator. Perform
the calibration as described in the calibrator instructions for use.

Calibration Frequency
Minimum Calibration Stability

Without Reagent Container

System Inserta With Reagent Container Inserta

ADVIA 1800 7 days 14 days

ADVIA 2400 5 days 14 days

a or whenever indicated by quality control data
Calibrate the assay after the following events:
• When the reagent lot number changes
• When a reagent pack is replaced by a new reagent pack with the same lot number, and
the previous reagent pack was recalibrated during use
• After replacing critical optical or hydraulic components
• When indicated by quality control procedures
Individual laboratory quality control programs and procedures may require more frequent
calibration.

Reagent Blank (RBL) Frequency

The ADVIA Chemistry system measures the RBL during assay calibration.
Run an additional RBL on the same reagent pack every day.

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Run an additional RBL when a reagent pack is replaced by a new reagent pack with the same
lot number, and an additional reagent blank was run during use.
Note Use deionized water as the sample for the RBL in the ADVIA Chemistry ACET assay.

Performing Quality Control

Follow government regulations or accreditation requirements for quality control frequency.
At least once each day of use, analyze 2 levels (low and high) of a commercially available
quality control (QC) material with known acetaminophen concentrations.
A satisfactory level of performance is achieved when the analyte values obtained are within
the expected control range for the system or within your range, as determined by an
appropriate internal laboratory quality control scheme.
The actual frequency of control in a laboratory is based on many factors, such as workflow,
system experience, and government regulation. Each laboratory should evaluate the controls
based on the frequency established by their laboratory guidelines.
Also, assay controls under the following conditions:
• Whenever you use a new reagent lot
• Following any system maintenance, cleaning, or troubleshooting procedure
• After performing a new calibration or an additional reagent blank
Follow your laboratory internal QC procedures if the results obtained are outside acceptable
limits.

Taking Corrective Action

If the quality control results do not fall within the expected control range or within the
laboratory’s established values, do not report results. Take the following actions:
1. Determine and correct the cause of the unacceptable control results:
a. Verify that the assay was performed according to the instructions for use.
b. Verify that the materials are not expired.
c. Verify that required maintenance was performed.
d. Rerun the assay with fresh quality control samples, and confirm that quality control
results are within acceptable limits before running patient samples.
e. If the quality control results are not within acceptable limits, recalibrate the assay, and
repeat the prior step.
f. If necessary, contact your local technical support provider or distributor for assistance.
2. After corrective action is complete, repeat required testing of patient samples before
reporting results.
Perform corrective actions in accordance with your established laboratory protocol.

Results
Calculation of Results
The system calculates and reports results based on the absorbance measurements of the test
sample during the test, and of the calibrator(s) from calibration.
The instrument calculates the concentration of acetaminophen in mg/dL (common units) or
μmol/L (SI units).
Conversion factor: mg/dL × 66.1 = μmol/L

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Interpretation of Results
Results of this assay should always be interpreted in conjunction with the patient's medical
history, clinical presentation, and other findings.

Limitations
A number of substances cause physiological changes in serum or plasma analyte
concentrations. A comprehensive discussion of possible interfering substances, their serum or
plasma concentrations, and their possible physiological involvements is beyond the scope of
this document. Consult the listed reference for specific details on known potential interfering
substances.12,13
As with any chemical reaction, you must be alert to the possible effect on results of unknown
interferences from medications or endogenous substances. The laboratory and physician must
evaluate all patient results in light of the total clinical status of the patient.
Specific therapy for acetaminophen overdose is to administer N‑acetyl cysteine (NAC,
Mucomyst). The potential for NAC interference in the acetaminophen assay was examined.
Our studies demonstrated no significant effect of NAC at levels up to 200 mg/L.

N‑Acetyl Cysteine (NAC)

A serum sample containing 10 mg/dL acetaminophen was tested with NAC at the
concentration of 200 mg/L.
Interference from N‑acetylcysteine (NAC) was evaluated on the ADVIA Chemistry system.
Using a significance criterion of > 10% variance from control, acceptable results were obtained
at the concentration of 200 mg/L NAC in a 10.2 mg/dL acetaminophen sample. This in vitro
analysis was performed approximately two hours after the addition of NAC to a serum pool.
Note Significantly reduced acetaminophen recovery has been demonstrated in situations
where testing has been performed immediately after NAC was introduced. Siemens
recommends that laboratories review NAC treatment and monitoring protocols to determine
the extent of the potential interference.
Note Siemens has determined that there is a possibility for certain ADVIA Chemistry reagents
to interact with the ADVIA Chemistry ACET assay when run on the same system. To mitigate
these carryover events, the ADVIA Chemistry system software provides a Contamination
Avoidance process. For further information and instructions to establish this process on your
systems, refer to the Customer Bulletin entitled: Consolidated Directory of Contamination
Avoidance Settings for ADVIA Chemistry Systems (PN 10813375, latest revision).

Therapeutic Range
The therapeutic range for acetaminophen is listed in the following table.14

Therapeutic Range 1–2 mg/dL (66–132 μmol/L)

Toxic Concentration 4 hours post ingestion > 15 mg/dL (992 μmol/L)

12 hours post ingestion > 4 mg/dL (264 μmol/L)

The toxic level of acetaminophen in serum depends on the time after ingestion. The Rumack-
Matthew nomogram many be helpful for assessing the toxicity associated with various serum
levels of the drug in cases of acute poisoning. Refer to the Merck Manual for more
information:
http://www.merckmanuals.com/professional/sec22/ch346/ch346b.html#v1118627
Siemens provides this information for reference. As with all in vitro diagnostic assays, each
laboratory should determine its own reference ranges for the diagnostic evaluation of patient
results. Consider these values as a guideline only.

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Performance Characteristics
Analytical Measuring Range
This assay is linear from 0.2–20.0 mg/dL (13.2–1322 μmol/L).
Results that are below the assay range are flagged L. You should report the test result as
< 0.2 mg/dL (< 7 μmol/L).
Results that are above the assay range are flagged H.

Extended Measuring Range

Siemens has validated an automatic rerun condition for this assay that extends the reportable
range to 60 mg/dL (3966 μmol/L). You may configure the system to trigger automatic reruns.
Rerun results will be flagged R.

Precision
The precision of the ADVIA Chemistry ACET assay was analyzed as described in CLSI protocol
EP05‑A2.15 Each sample was assayed 2 times per run, 1 or 2 runs per day, for at least 10 days.
ADVIA 1650/1800

Repeatability Within‑Lab
(Within‑Run) (Total)

CVb CV
Specimen Type Mean SDa (%) SD (%)

Common Units (mg/dL)

Serum 1 3.2 0.02 0.6 0.04 1.2

Serum 2 9.4 0.06 0.6 0.11 1.1

Serum 3 18.2 0.10 0.5 0.20 1.1

SI Units (µmol/L)

Serum 1 212 1.3 0.6 2.6 1.2

Serum 2 621 4.0 0.6 7.3 1.1

Serum 3 1203 6.6 0.5 13.2 1.1

a SD = standard deviation
b CV = coefficient of variation

ADVIA 2400

Repeatability Within‑Lab
(Within‑Run) (Total)

CVb CV
Specimen Type Mean SDa (%) SD (%)

Common Units (mg/dL)

Serum 1 4.3 0.02 0.5 0.06 1.5

Serum 2 8.5 0.11 1.2 0.14 1.7

Serum 3 17.2 0.09 0.5 0.22 1.3

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Repeatability Within‑Lab
(Within‑Run) (Total)

CVb CV
Specimen Type Mean SDa (%) SD (%)

SI Units (µmol/L)

Serum 1 284 1.3 0.5 4.0 1.5

Serum 2 562 7.3 1.2 9.3 1.7

Serum 3 1137 6.0 0.5 14.6 1.3

a SD = standard deviation
b CV = coefficient of variation
Actual results will vary depending on the study design, and on the sample and sample
population used. Results obtained at individual laboratories may vary from the data provided.

Accuracy / Method Comparison

The performance of the ADVIA Chemistry ACET assay (y) was compared with the performance
of the comparison assay on the indicated system (x).
ADVIA 1650/1800

Specimen
Type Comparison Assay (x) N r Regression Equation Sy.x Sample Range

Serum Sekisui Acetaminophen- 95 1.000 y = 1.021x + 0.18 mg/dL 0.16 mg/dL 0.4–19.5 mg/dL
SL on Hitachi 717 1.000 y = 1.021x + 11.9 μmol/L 10.6 μmol/L 26–1289 μmol/L

Plasmaa ADVIA 1650/1800 24 1.000 y = 1.010x - 0.03 mg/dL 0.17 mg/dL 0.8–18.0 mg/dL
(serum) 1.000 y = 1.010x - 2.0 μmol/L 11.2 μmol/L 53–1190 μmol/L
a lithium heparin (matrix comparison)

ADVIA 2400

Specimen
Type Comparison Assay (x) N r Regression Equation Sy.x Sample Range

Serum ADVIA 1650/1800 67 0.999 y = 1.025x + 0.03 mg/dL 0.08 mg/dL 0.5–19.2 mg/dL
0.999 y = 1.025x + 2.0 μmol/L 5.3 μmol/L 33–1269 μmol/L

Plasmaa ADVIA 2400 (serum) 24 1.000 y = 1.010x - 0.04 mg/dL 0.22 mg/dL 0.8–19.8 mg/dL
1.000 y = 1.010x - 2.6 μmol/L 14.5 μmol/L 53–1309 μmol/L
a lithium heparin (matrix comparison)
The correlation of the assay may vary depending on the study design, comparable method,
and sample population. Results obtained at individual laboratories may vary from the data
provided.

Interferences
Siemens tested the following potential interferents and found the results shown below.

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ADVIA 1650/1800

Interferent Interferent Level Acetaminophen Sample Concentration Interference

Bilirubin 15 mg/dL 3.4 mg/dL NSIa

(conjugated) (257 μmol/L) (225 μmol/L)

20 mg/dL 3.4 mg/dL +11.5%

(342 μmol/L) (225 μmol/L)

5 mg/dL 1.7 mg/dL NSI

(86 μmol/L) (112 μmol/L)

10 mg/dL 1.7 mg/dL +14.0%

(171 μmol/L) (112 μmol/L)

Bilirubin 5 mg/dL 3.4 mg/dL NSI

(unconjugated) (86 μmol/L) (225 μmol/L)

10 mg/dL 3.4 mg/dL +11.5%

(171 μmol/L) (225 μmol/L)

5 mg/dL 1.7 mg/dL +11.7%

(86 μmol/L) (112 μmol/L)

Hemolysis 250 mg/dL 3.4 mg/dL NSI

(hemoglobin) (2.5 g/L) (225 μmol/L)

500 mg/dL 3.4 mg/dL +13.4%

(5.0 g/L) (225 μmol/L

250 mg/dL 1.7 mg/dL +13.5%

(2.5 g/L) (112 μmol/L

Lipemiab 250 mg/dL 3.4 mg/dL NSI

(from Intralipid) (2.8 mmol/L) (225 μmol/L)

500 mg/dL 3.4 mg/dL -10.8%

(5.7 mmol/L) (225 μmol/L)

250 mg/dL 1.7 mg/dL NSI

(2.8 mmol/L) (112 μmol/L)

500 mg/dL 1.7 mg/dL -18.4%

(5.7 mmol/L) (112 μmol/L)
a NSI = No significant interference. A percentage effect ≥ 10% is considered a significant interference.
b SI units calculated as triolein

ADVIA 2400

Interferent Interferent Level Acetaminophen Sample Concentration Interference

Bilirubin 10.0 mg/dL 3.0 mg/dL NSIa

(conjugated) (171 μmol/L) (198 μmol/L)

12.5 mg/dL 3.0 mg/dL +11.2%

(214 μmol/L) (198 μmol/L)

2.5 mg/dL 1.6 mg/dL NSI

(43 μmol/L) (106 μmol/L)

5.0 mg/dL 1.6 mg/dL +10.4%

(86 μmol/L) (106 μmol/L)

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Interferent Interferent Level Acetaminophen Sample Concentration Interference

Bilirubin 5.0 mg/dL 3.0 mg/dL NSI

(unconjugated) (86 μmol/L) (198 μmol/L)

7.5 mg/dL 3.0 mg/dL +10.0%

(128 μmol/L) (198 μmol/L)

5.0 mg/dL 1.6 mg/dL +12.5%

(86 μmol/L) (106 μmol/L)

Hemolysis 250 mg/dL 2.9 mg/dL NSI

(hemoglobin) (2.5 g/L) (192 μmol/L)

375 mg/dL 2.9 mg/dL +13.8%

(3.8 g/L) (192 μmol/L)

250 mg/dL 1.6 mg/dL +18.8%

(2.5 g/L) (106 μmol/L)

Lipemiab 500 mg/dL 2.9 mg/dL NSI

(from Intralipid) (5.7 mmol/L) (192 μmol/L)

625 mg/dL 2.9 mg/dL -10.3%

(7.1 mmol/L) (192 μmol/L)

250 mg/dL 1.6 mg/dL NSI

(2.8 mmol/L) (106 μmol/L)

375 mg/dL 1.6 mg/dL -12.5%

(4.2 mmol/L) (106 μmol/L)
a NSI = No significant interference. A percentage effect ≥ 10% is considered a significant interference.
b SI units calculated as triolein
Note There is poor correlation between turbidity and triglyceride concentration in a lipemic
sample.16
Actual results will vary depending on the study design, the levels of the potential interferences
tested, and the samples used. Results obtained at individual laboratories may vary from the
data provided.

Cross Reactivity
Siemens tested the following potentially interfering drugs up to the indicated levels and found
the following results:

Effect at 0.5 mg/dL Acetamino- Effect at 3 mg/dL Acetamino-

Substance Tested Concentration Tested phen phen

Acetylsalicylic Acid 6.5 mmol/L NSIa NSIa

Amitriptyline 3.6 μmol/L NSI NSI

Ampicillin 152 μmol/L NSI NSI

Ascorbic Acid 342 μmol/L NSI NSI

Cefoxitin 1546 μmol/L NSI NSI

Doxycycline 67.5 μmol/L NSI NSI

Ibuprofen 2425 μmol/L NSI NSI

Imipramine 2.5 μmol/L NSI NSI

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Effect at 0.5 mg/dL Acetamino- Effect at 3 mg/dL Acetamino-

Substance Tested Concentration Tested phen phen

Levodopa 25.3 μmol/L NSI NSI

Methyl-L‑Dopa 71 μmol/L NSI NSI

Metronidazole 701 μmol/L NSI NSI

Phenylbutazone 2.9 mmol/L NSI NSI

Rifamipicin 78.1 μmol/L +38.9% NSI

Salicylate 4.3 mmol/L NSI NSI

Theophylline 222 μmol/L NSI NSI

a NSI = No significant interference. A percentage effect ≥ 10% is considered a significant interference.

Standardization
The ADVIA Chemistry ACET assay is traceable to an internal standard manufactured using
highly purified material.17 Assigned values of Siemens ToxAmmonia Calibrator are traceable to
this standardization.

Technical Assistance
For customer support, please contact your local technical support provider or distributor.
siemens.com/healthcare

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References
1. Ameer B, Greenblatt DJ. Acetaminophen. Ann Intern Med. 1977 Aug;87(2):202–209.
2. Barker JD, de Carle DJ, Annras S. Chronic excessive acetaminophen use and liver damage.
Ann Intern Med. 1977 Sep;87(3):299–301.
3. Prescott LF. The nephrotoxicity and hepatotoxicity of antipyretic analgesics. Brit J Clin.
Pharmacol. 7: 453–462 (1979)
4. Black M. Acetaminophen hepatotoxicity. Gastroenterology, 1980 Feb; 78(2):382–392.
5. Ambre J, Alexander M, JAMA. Liver Toxicity After Acetaminophen Ingestion. 1977 Aug 8;
238(6):500–501.
6. Vale JA, Meredith TJ, Goulding R. Treatment of acetaminophen poisoning. The use of oral
methionine. Arch Intern Med. 1981 Feb 23; 141(3 Spec No):394–396.
7. Kaplan LA, Pesce AJ, Clinical chemistry, theory, analysis and correlation. The C.V. Mosby
Company; 1066-1069 (1989).
8. Price CP, Hammond PM, Seawen MD. Evaluation of an enzymatic procedure for the
measurement of acetaminophen. Clin. Chem. 29: 358–361 (1983).
9. Clinical and Laboratory Standards Institute (formerly NCCLS). Procedures for the Collection
of Diagnostic Blood Specimens by Venipuncture; Approved Guideline—Sixth Edition. CLSI
document GP41-A6. Wayne, PA: Clinical and Laboratory Standards Institute; 2008.
10. Clinical and Laboratory Standards Institute (formerly NCCLS). Tubes and Additives for
Venous Blood Specimen Collection: Approved Standard; Approved Guideline—Sixth
Edition. CLSI document GP39-A6. Wayne, PA: Clinical and Laboratory Standards Institute;
2010.
11. Clinical and Laboratory Standards Institute (formerly NCCLS). Procedures for the Handling
and Processing of Blood Specimens; Approved Guideline—Fourth Edition. CLSI document
GP44-A4. Wayne, PA: Clinical and Laboratory Standards Institute; 2010.
12. Martin EW, Hazards of Medication, Alexander SF, Farage DJ, Hassan WE, jr., editors, J. B.
Lippincott Company, Philadelphia, PA and Toronto, Canada, 169-189 (1971).
13. Young DS. Effects of Drugs on Clinical Laboratory Tests. 5th ed. Washington, DC: AACC
Press; 2000.
14. Wu AHB, ed. Tietz Clinical Guide to Laboratory Tests, 4th ed. St. Louis, MO: WB Saunders
Company; 2006:1238.
15. Clinical and Laboratory Standards Institute (formerly NCCLS). Evaluation of Precision
Performance of Quantitative Measurement Methods; Approved Guideline—Second
Edition. CLSI document EP05-A2. Wayne, PA: Clinical and Laboratory Standards Institute;
2004.
16. Twomey PJ, Don-Wauchope AC, McCullough D. Unreliability of triglyceride measurement
to predict turbidity induced interference. J Clin Pathol. 2003 Nov;56(11):861–862.
17. Internal Siemens Healthcare Diagnostics procedure.

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Definition of Symbols
The following symbols may appear on the product labeling:

Symbol Definition Symbol Definition

In vitro diagnostic medical device Catalog number

Legal manufacturer Authorized Representative in the

European Community

CE Mark CE Mark with identification number

of notified body
0088

Consult instructions for use Biological risk

Keep away from sunlight and heat Temperature limitation

Lower limit of temperature Upper limit of temperature

Do not freeze (> 0°C) Up

Use by Contains sufficient for (n) tests

Recycle Printed with soy ink

Rev. Revision Date format (year-month-day)

Batch code RxOnly Prescription Device (US only)

Trademarks
ADVIA is a trademark of Siemens Healthcare Diagnostics.
Hitachi 717 is a trademark of Hitachi Ltd.
Intralipid is a trademark of Fresenius Kabi AB.
Mucomyst is a trademark of Bristol-Myers Squibb Company.
Sekisui is a trademark of Sekisui Diagnostics.
© 2008–2020 Siemens Healthcare Diagnostics. All rights reserved.

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