en

Anti-HCV
08P06
Anti-HCV Reagent Kit G71272R05
B8P060
Read Highlighted Changes: Revised February 2020.

08P0622
08P0632
Instructions must be carefully followed. Reliability of assay results be asymptomatic, HCV infection may develop into chronic hepatitis,
cannot be guaranteed if there are any deviations from these cirrhosis, and/or increased risk of hepatocellular carcinoma.12-15 The
instructions. implementation of blood donation screening for anti-HCV by EIAs
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NAME has led to a marked decline in the risk of transfusion-transmitted
hepatitis.16, 17
Alinity i Anti-HCV Reagent Kit
Alinity i Anti-HCV has been designed to detect antibodies to putative
ll
INTENDED USE structural and nonstructural proteins of the HCV genome. The
The Alinity i Anti-HCV assay is a chemiluminescent microparticle relationship between the recombinant HCV proteins in Alinity i Anti-
immunoassay (CMIA) used for the qualitative detection of antibody to HCV and the putative structural and nonstructural proteins of the
Hepatitis C virus (anti-HCV) in human serum and plasma, including HCV genome is depicted below.18
specimens collected post mortem (non-heart beating) on the Alinity • HCr43: The HCr43 protein is expressed in Escherichia coli (E.
i analyzer. coli) and is composed of two noncontiguous coding regions
The Alinity i Anti-HCV assay is intended to be used as an aid in the of the HCV genome sequence. The first region represents
diagnosis of Hepatitis C infection and as a screening test to prevent amino acids 1192 to 1457 (33c) of the HCV sequence. The
transmission of Hepatitis C virus (HCV) to recipients of blood, blood second of the two regions represents amino acids 1 to 150
components, cells, tissue and organs. (core) of the HCV sequence. Because of the similarity of the
genomic organization of the flaviviruses, it is suggested that the
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SUMMARY AND EXPLANATION OF THE TEST first sequence is from the NS3 coding region and the second
The Alinity i Anti-HCV assay is for the detection of antibodies to sequence is from the core coding region of HCV.
hepatitis C virus (HCV). Chemiluminescent immunoassays are • c100-3: The c100-3 antigen is a recombinant HCV protein
a variation of the enzyme immunoassay (EIA) principle. Solid expressed in Saccharomyces cerevisiae (yeast). The genomic
phase EIAs, first described in the early 1970s, use antigens and/or organization of flaviviruses suggests that the cloned sequence
antibodies coated on a surface to bind complementary analytes.1 is contained within the putative nonstructural (NS3 and NS4)
The bound analyte is detected by a series of antigen-antibody regions of HCV. The c100-3 protein is a chimeric fusion protein
reactions. EIAs are available to identify antigens and antibodies with 154 amino acids of human superoxide dismutase (hSOD),
related to viral hepatitis infection. In the Alinity i Anti-HCV final five linker amino acids, amino acids number 1569 to 1931 of the
reaction, bound acridinylated conjugates are used to generate a HCV polyprotein, and the additional five amino acid linker at the
chemiluminescent signal. carboxyl terminus.
HCV is a bloodborne virus.2, 3 Serological studies employing EIAs
for detection of antibodies to recombinant antigens of HCV have
established HCV as the cause of most bloodborne4-9 as well as
community-acquired10 non-A, non-B hepatitis. The presence of anti-
HCV indicates that an individual may have been infected with HCV,
may harbor infectious HCV, and/or may be capable of transmitting
HCV infection.11 Although the majority of infected individuals may

1
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BIOLOGICAL PRINCIPLES OF THE PROCEDURE The following warnings and precautions apply to:
This assay is a two-step immunoassay for the qualitative detection
of anti-HCV in human serum and plasma using chemiluminescent
microparticle immunoassay (CMIA) technology.
Sample, recombinant HCV antigen coated paramagnetic
microparticles, and assay diluent are combined and incubated. WARNING Contains polyethylene glycol octylphenyl
The anti-HCV present in the sample binds to the HCV coated ether (Triton X-405).
microparticles. The mixture is washed. Anti-human acridinium-labeled H319 Causes serious eye irritation.
conjugate is added to create a reaction mixture and incubated. Prevention
Following a wash cycle, Pre-Trigger and Trigger Solutions are added. P264 Wash hands thoroughly after handling.
The resulting chemiluminescent reaction is measured as relative light P280 Wear protective gloves / protective
units (RLUs). There is a direct relationship between the amount of clothing / eye protection.
anti-HCV in the sample and the RLUs detected by the system optics. Response
The presence or absence of anti-HCV in the sample is determined P305+P351+P338 IF IN EYES: Rinse cautiously with water
by comparing the chemiluminescent RLU in the reaction to the cutoff for several minutes. Remove contact
RLU determined from an active calibration. lenses, if present and easy to do.
For additional information on system and assay technology, refer to Continue rinsing.
the Alinity ci-series Operations Manual, Section 3. P337+P313 If eye irritation persists: Get medical
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REAGENTS advice / attention.
Kit Contents The following warnings and precautions apply to:
Alinity i Anti-HCV Reagent Kit 08P06
NOTE: Some kit sizes are not available in all countries. Please
contact your local distributor.
Volumes (mL) listed in the table below indicate the volume per
DANGER Contains polyethylene glycol octylphenyl
cartridge.
ether (Triton X-405) and tromethamine
08P0622 08P0632 hydrochloride*.
Tests per cartridge 100 500 H318 Causes serious eye damage.
Number of cartridges H316* Causes mild skin irritation.
2 2
per kit H402* Harmful to aquatic life.
Tests per kit 200 1000 H412 Harmful to aquatic life with long lasting
6.6 mL 27.0 mL effects.
6.1 mL 26.5 mL Prevention
P280 Wear protective gloves / protective
10.4 mL 47.1 mL
clothing / eye protection.
 HCV (E.coli, yeast, recombinant) antigen coated P273 Avoid release to the environment.
microparticles in MES buffer. Minimum concentration: 0.14% solids. Response
Preservatives: antimicrobial agents. P305+P351+P338 IF IN EYES: Rinse cautiously with water
 murine anti-IgG/anti-IgM acridinium-labeled conjugate for several minutes. Remove contact
in MES buffer. Minimum concentration: (IgG) 8 ng/mL/(IgM) lenses, if present and easy to do.
0.8 ng/mL. Preservatives: antimicrobial agents. Continue rinsing.
P332+P313* If skin irritation occurs: Get medical
 TRIS buffer with protein stabilizers. Preservatives: advice / attention.
antimicrobial agents.
P310 Immediately call a POISON CENTER or
Warnings and Precautions doctor / physician.
• Disposal
P501 Dispose of contents / container in
• For In Vitro Diagnostic Use
accordance with local regulations.
Safety Precautions
CAUTION: This product requires the handling of human specimens. * Not applicable where regulation EU 1272/2008 (CLP) has been
It is recommended that all human-sourced materials be considered implemented.
potentially infectious and handled in accordance with the OSHA Safety Data Sheets are available at www.abbottdiagnostics.com or
Standard on Bloodborne Pathogens. Biosafety Level 2 or other contact your local representative.
appropriate biosafety practices should be used for materials that For a detailed discussion of safety precautions during system
contain or are suspected of containing infectious agents.19-22 operation, refer to the Alinity ci-series Operations Manual, Section 8.
Reagent Handling
• Upon receipt, gently invert the unopened reagent kit by rotating
it over and back for a full 180 degrees, 5 times with green label
stripe facing up and then 5 times with green label stripe facing
down. This ensures that liquid covers all sides of the bottles
within the cartridges. During reagent shipment, microparticles
can settle on the reagent septum.
–– Place a check in the square on the reagent kit to indicate to
others that the inversions have been completed.

2
• After mixing, place reagent cartridges in an upright position for ll
INSTRUMENT PROCEDURE
1 hour before use to allow bubbles that may have formed to The Alinity i Anti-HCV assay file must be installed on the Alinity i
dissipate. analyzer prior to performing the assay.
• If a reagent cartridge is dropped, place in an upright position For detailed information on assay file installation and viewing and
for 1 hour before use to allow bubbles that may have formed to editing assay parameters, refer to the Alinity ci-series Operations
dissipate. Manual, Section 2.
• Prior to loading on the analyzer for the first time, gently invert For information on printing assay parameters, refer to the Alinity ci-
cartridge 30 times. series Operations Manual, Section 5.
• Reagent cartridges cannot be inverted after the septum has For a detailed description of system procedures, refer to the Alinity
been pierced by the analyzer. ci-series Operations Manual.
• Reagents are susceptible to the formation of foam and bubbles.
Bubbles may interfere with the detection of the reagent level in ll
SPECIMEN COLLECTION AND PREPARATION
the cartridge and cause insufficient reagent aspiration that may FOR ANALYSIS
adversely affect results. Specimen Types
For a detailed discussion of reagent handling precautions during The specimen types listed below were verified for use with this assay
system operation, refer to the Alinity ci-series Operations Manual, on the ARCHITECT i System.
Section 7. Other specimen types and collection tube types have not been
Reagent Storage verified with this assay.
Storage Maximum Additional Storage Specimen Types Collection Tubes
Temperature Storage Time Instructions Serum Serum
Unopened 2 to 8°C Until Store in upright position. Serum separator
expiration If cartridge does not Plasma Potassium EDTA
date remain upright, gently Lithium heparin
invert the cartridge 10 Sodium heparin
times and place in an
Sodium citrate
upright position for 1 hour
ACD
before use.
CPDA-1
Prior to loading on the
analyzer for the first time, CPD
gently invert cartridge 30 CP2D
times. Potassium oxalate
Onboard System 30 days • Performance has been established for the use of cadaveric
Temperature blood specimens (specimens collected post-mortem, non-heart-
Opened 2 to 8°C Until Store in upright position. beating) that have been collected up to 15 hours after death.
expiration If cartridge does not Performance was established using 50 spiked and 50 non-spiked
date remain upright during cadaveric blood specimens.23
storage, discard the • Testing of cadaveric blood specimens from patients with plasma
cartridge. dilution due to transfusions of > 2000 mL of blood or colloids
Reagent cartridges cannot within 48 hours, or > 2000 mL of crystalloids within 1 hour (or
be inverted after the any combination thereof) prior to collection of the specimens
septum has been pierced have not been validated.
by the analyzer. • For cadaveric donors, serum and plasma may be used; follow
Do not reuse original general standards and/or regulations for collection, storage and
reagent caps or handling.
replacement caps due to • The instrument does not provide the capability to verify specimen
the risk of contamination types. It is the responsibility of the operator to verify that the
and potential to correct specimen types are used in the assay.
compromise reagent
performance. Specimen Conditions
• Do not use:
Reagents may be stored on or off the system. If removed from the –– heat-inactivated specimens
system, store reagents with new replacement caps in an upright
–– pooled specimens
position at 2 to 8°C. For reagents stored off the system, it is
–– grossly hemolyzed specimens
recommended that they be stored in their original trays or boxes to
ensure they remain upright. • For accurate results, serum and plasma specimens should be
free of fibrin, red blood cells, and other particulate matter. Serum
For information on unloading reagents, refer to the Alinity ci-series
specimens from patients receiving anticoagulant or thrombolytic
Operations Manual, Section 5.
therapy may contain fibrin due to incomplete clot formation. If
Indications of Reagent Deterioration the specimen is centrifuged before a complete clot forms, the
Deterioration of the reagents may be indicated when a calibration presence of fibrin may cause erroneous results.
error occurs or a control value is out of the specified range. • Specimens from heparinized patients may be partially coagulated
Associated test results are invalid, and samples must be retested. and erroneous results could occur due to the presence of fibrin.
Assay recalibration may be necessary. To prevent this phenomenon, draw the specimen prior to heparin
For troubleshooting information, refer to the Alinity ci-series therapy.
Operations Manual, Section 10. • To prevent cross contamination, use of disposable pipettes or
pipette tips is recommended.

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Preparation for Analysis Maximum
• Follow the tube manufacturer’s processing instructions for Specimen Storage
collection tubes. Gravity separation is not sufficient for specimen Type Temperature Time Special Instructions
preparation. Serum/ 2 to 8°C 7 days Specimens may be
• Specimens should be free of bubbles. Remove bubbles with an Plasma stored on or off the
applicator stick before analysis. Use a new applicator stick for clot or red blood cells.
each specimen to prevent cross contamination. Cadaveric Room 3 days If specimens are
To ensure consistency in results, recentrifuge specimens prior to temperature not processed
testing if (15 to 30°C) directly after initial
• they contain fibrin, red blood cells, or other particulate matter. centrifugation, it
NOTE: If fibrin, red blood cells, or other particulate matter are is recommended
observed, mix by low speed vortex or by inverting 10 times prior to to remove the
recentrifugation. supernatant from the
Prepare frozen specimens as follows: clot, red blood cells
• Frozen specimens must be completely thawed before mixing. or separator gel until
further processing.
• Mix thawed specimens thoroughly by low speed vortex.
• Visually inspect the specimens. If layering or stratification is 2 to 8°C 7 days If specimens are
observed, mix until specimens are visibly homogeneous. not processed
• If specimens are not mixed thoroughly, inconsistent results may directly after initial
be obtained. centrifugation, it
is recommended
• Recentrifuge specimens.
to remove the
Prepare cadaveric blood specimens as follows: supernatant from the
• After initial centrifugation, recentrifuge specimens as described clot, red blood cells
below. or separator gel until
• If specimens are not processed directly after initial centrifugation, further processing.
it is recommended to remove the supernatant from the clot, red
blood cells or separator gel until further processing. Specimens may be stored for up to 7 days refrigerated at 2-8°C
Recentrifugation of Specimens prior to being tested. If testing will be delayed more than 7 days,
• Transfer specimens to a centrifuge tube and centrifuge at a the specimens should be removed from the clot, red blood cells, or
minimum of 100 000 g-minutes. separator gel and stored frozen (-20°C or colder).
• Examples of acceptable time and force ranges that meet this Avoid more than 6 freeze/thaw cycles for serum/plasma.
criterion are listed in the table below. No qualitative differences were observed for cadaveric blood
Centrifugation time using alternate RCF values can be calculated specimens (nonreactive or spiked reactive) when subjected to up to
using the following formula: 3 freeze/thaw cycles.
100 000 g-minutes Specimen Shipping
Minimum Centrifugation time (minutes) = Package and label specimens in compliance with applicable state,
RCF
federal, and international regulations covering the transport of clinical
Recentrifugation Time
(Minutes) RCF (x g) g-Minutes specimens and infectious substances.
10 10 000 100 000 ll
PROCEDURE
20 5000 100 000 Materials Provided
40 2500 100 000 08P06 Alinity i Anti-HCV Reagent Kit
RCF = 1.12 × rmax (rpm/1000)2 Materials Required but not Provided
RCF - The relative centrifugal force generated during • Alinity i Anti-HCV assay file
centrifugation. • 08P0601 Alinity i Anti-HCV Calibrator
rpm - The revolutions per minute of the rotor on which • 08P0610 Alinity i Anti-HCV Controls or other control material
the specimens are being spun (usually the digital • Alinity Trigger Solution
readout on the centrifuge will indicate the rpm).
• Alinity Pre-Trigger Solution
Centrifugation The time should be measured from the time the
• Alinity i-series Concentrated Wash Buffer
Time - rotor reaches the required RCF or rpm to the time it
For information on materials required for operation of the instrument,
begins decelerating.
refer to the Alinity ci-series Operations Manual, Section 1.
rmax - Radius of the rotor in millimeters. NOTE: If custom
tube adapters (i.e., adapters not defined by the For information on materials required for maintenance procedures,
centrifuge manufacturer) are used, then the radius refer to the Alinity ci-series Operations Manual, Section 9.
(rmax) should be manually measured in millimeters Assay Procedure
and the RCF calculated. For a detailed description of how to run an assay, refer to the Alinity
g-minutes - The unit of measure for the product of RCF (× g) ci-series Operations Manual, Section 5.
and centrifugation time (minutes). Prior to loading on the analyzer for the first time, gently invert the
reagent cartridge 30 times.
• Transfer clarified specimen to a sample cup or secondary tube
for testing. For centrifuged specimens with a lipid layer, transfer • If using primary or aliquot tubes, refer to the Alinity ci-series
only the clarified specimen and not the lipemic material. Operations Manual, Section 4 to ensure sufficient specimen is
present.
Specimen Storage • To minimize the effects of evaporation, verify adequate sample
Specimen storage conditions were verified on the ARCHITECT i cup volume is present prior to running the test.
System.

4
• Maximum number of replicates sampled from the same sample • If more frequent control monitoring is required, follow the
cup: 10 established quality control procedures for your laboratory.
–– Priority: • If quality control results do not meet the acceptance criteria
◦◦ Sample volume for first test: 70 µL defined by your laboratory, sample results may be suspect.
◦◦ Sample volume for each additional test from same sample Follow the established quality control procedures for your
cup: 20 µL laboratory. Recalibration may be necessary. For troubleshooting
information, refer to the Alinity ci-series Operations Manual,
–– ≤ 3 hours on the reagent and sample manager:
Section 10.
◦◦ Sample volume for first test: 150 µL
• Review quality control results and acceptance criteria following a
◦◦ Sample volume for each additional test from same sample change of reagent or calibrator lot.
cup: 20 µL Quality Control Guidance
–– > 3 hours on the reagent and sample manager: Refer to “Basic QC Practices” by James O Westgard, Ph.D. for
◦◦ Replace with a fresh aliquot of sample. guidance on laboratory quality control practices.25
• Refer to the Alinity i Anti-HCV calibrator package insert and/ Verification of Assay Claims
or Alinity i Anti-HCV controls package insert for preparation and For protocols to verify package insert claims, refer to Verification of
usage. Assay Claims in the Alinity ci-series Operations Manual.
• For general operating procedures, refer to the Alinity ci-series
Operations Manual, Section 5. ll
RESULTS
• For optimal performance, it is important to perform routine Calculation
maintenance as described in the Alinity ci-series Operations The Alinity i analyzer calculates results for the Alinity i Anti-HCV
Manual, Section 9. Perform maintenance more frequently when assay using the ratio of the sample RLU to the cutoff RLU (S/CO) for
required by laboratory procedures. each specimen and control.
Sample Dilution Procedures Cutoff RLU = Calibrator 1 Mean RLU x 0.074
Samples cannot be diluted for the Alinity i Anti-HCV assay. The cutoff RLU is stored for each reagent lot calibration.
S/CO = Sample RLU/Cutoff RLU
Calibration
For instructions on performing a calibration, refer to the Alinity ci- Interpretation of Results
series Operations Manual, Section 5. The cutoff is 1.00 S/CO.
Each assay control must be tested to evaluate the assay calibration. Initial Results
Once a calibration is accepted and stored, all subsequent samples Instrument
S/CO Interpretation Retest Procedure
may be tested without further calibration unless:
< 1.00 Nonreactive No retest required.
• A reagent kit with a new lot number is used.
≥ 1.00 Reactive Retest in duplicate.
• Daily quality control results are outside of statistically-based
quality control limits used to monitor and control system Duplicate Retest Results
performance, as described in the Quality Control Procedures Instrument Interpretation Specimen Classification
section of this package insert. Both results nonreactive Specimen considered nonreactive
–– If statistically-based quality control limits are not available, for anti-HCV.
then the calibration should not exceed a 30-day limit for One or both results reactive Specimen considered repeatedly
recalibration frequency. reactive for anti-HCV.
This assay may require recalibration after maintenance to critical
parts or subsystems or after service procedures have been Repeatedly reactive anti-HCV specimens should be investigated
performed. further in supplemental tests such as other HCV-specific
immunoassays and immunoblot assays or a combination thereof
Quality Control Procedures and/or NAT tests.
The recommended control requirement for the Alinity i Anti-HCV NOTE: For details on configuring the Alinity i analyzer to use
assay is that a single sample of each control level be tested once grayzone and high reactive interpretations, refer to the Alinity ci-
every 24 hours each day of use. series Operations Manual, Section 2. The grayzone and high reactive
Additional controls may be tested in accordance with local, state, interpretations are editable parameters, and should be utilized per
and/or federal regulations or accreditation requirements and your end user requirements.
laboratory’s quality control policy.
Flags
To establish statistically-based control limits, each laboratory should
Some results may contain information in the Flags field. For a
establish its own concentration target and ranges for new control lots
description of the flags that may appear in this field, refer to the
at each clinically relevant control level. This can be accomplished
Alinity ci-series Operations Manual, Section 5.
by assaying a minimum of 20 replicates over several (3-5) days and
using the reported results to establish the expected average (target) ll
LIMITATIONS OF THE PROCEDURE
and variability about this average (range) for the laboratory. Sources • False positive results can be expected with any test kit. The
of variation that should be included in this study in order to be proportion of these falsely reactive specimens is dependent
representative of future system performance include: upon the specificity of the test kit, specimen integrity, and on the
• Multiple stored calibrations prevalence of HCV antibodies in the population being screened.
• Multiple reagent lots • If the Alinity i Anti-HCV results are inconsistent with clinical
• Multiple calibrator lots evidence, additional testing is suggested to confirm the result.
• Multiple processing modules (if applicable) • For diagnostic purposes, results should be used in conjunction
• Data points collected at different times of the day with patient history and other hepatitis markers for diagnosis of
Refer to published guidelines for information or general control acute or chronic infection.
recommendation, for example Clinical and Laboratory Standards • Specimens from heparinized patients may be partially coagulated
Institute (CLSI) Document C24-A3 or other published guidelines, for and erroneous results could occur due to the presence of fibrin.
general quality control recommendations.24 To prevent this phenomenon, draw the specimen prior to heparin
therapy.

5
ll
SPECIFIC PERFORMANCE CHARACTERISTICS a Repeatedly reactive specimens determined to be positive by
Representative performance data are provided in this section. supplemental testing or unable to be categorized were excluded from
Results obtained in individual laboratories may vary. these calculations.
b A repeatedly reactive specimen observed on the Alinity i Anti-HCV
The Alinity i analyzer and the ARCHITECT i System utilize the same
reagents and sample/reagent ratios. assay showed discrepant results between the Alinity i Anti-HCV
Unless otherwise specified, all studies were performed on the Alinity assay (1.47 S/CO, 1.17 S/CO, and 1.08 S/CO) and the commercially-
i analyzer. available anti-HCV assay (0.99 S/CO).

Precision Sensitivity
Within-Laboratory Precision Anti-HCV Positive, Acute and Chronic HCV Infection, and Genotypes
1 to 6
A study was performed based on guidance from CLSI EP05-A2.26
Testing was conducted using 3 lots of the Alinity i Anti-HCV Reagent A total of 459 confirmed positive specimens were evaluated using
Kit, 3 lots of the Alinity i Anti-HCV Calibrator, and 3 lots of the Alinity the Alinity i Anti-HCV assay and a commercially-available Anti-HCV
i Anti-HCV Controls and 1 instrument. Two controls and 3 human assay.
plasma panels were assayed in a minimum of 2 replicates at 2 Commercially-
separate times per day on 20 different days. Available Anti-
Alinity i Anti-HCV HCV Assay
Within-Run Specimen Category n Number RR Sensitivity Sensitivity
(Repeatability) Within-Laboratory (Total)a
Anti-HCV Positive 302 302 100.00% 100.00%
Mean SD %CV (302/302) (302/302)
Sample n (S/CO) SD %CV (Rangeb) (Rangeb)
Acute HCV Infection 28 28 100.00% 100.00%
Negative 358 0.06 0.009 16.2 0.011 18.8 (28/28) (28/28)
Control (0.011-0.011) (16.4-22.2)
Chronic HCV 22 22 100.00% 100.00%
Positive 356 3.83 0.143 3.7 0.205 5.4 Infection (22/22) (22/22)
Control (0.152-0.279) (3.9-7.6)
Genotype 1 22 22 100.00% 100.00%
Panel 1 360 0.75 0.030 4.0 0.041 5.5 (22/22) (22/22)
(0.036-0.049) (4.6-7.0)
Genotype 2 24 24 100.00% 100.00%
Panel 2 357 1.29 0.049 3.8 0.064 5.0 (24/24) (24/24)
(0.054-0.080) (4.0-6.6)
Genotype 3 23 23 100.00% 100.00%
Panel 3 360 3.10 0.128 4.1 0.168 5.4 (23/23) (23/23)
(0.133-0.222) (4.2-7.5)
Genotype 4 23 23 100.00% 100.00%
a Includes within-run, between-run, and between-day variability. (Including non-a (23/23) (23/23)
b Maximum and minimum SD or %CV for each reagent lot and subtype)
Genotype 5 12 12 100.00% 100.00%
instrument combination.
(12/12) (12/12)
Specificity Genotype 6 3 3 100.00% 100.00%
A total of 5123 specimens from blood donors and hospitalized (3/3) (3/3)
patients (HP) were tested using the Alinity i Anti-HCV assay and Total 459 459 100.00% 100.00%
a commercially-available Anti-HCV assay. Repeatedly reactive (459/459) (459/459)
specimens were further tested by supplemental testing.
RR = Repeatedly Reactive
Of the 10 initially reactive donor specimens, 7 were repeatedly
reactive and confirmed negative by supplemental testing. The overall sensitivity was estimated in these studies to be 100.00%
(459 /459) with a 95% confidence interval of 99.20 to 100.00%.
Of the 25 initially reactive hospitalized patient specimens, 16
specimens were confirmed positive, 6 specimens were negative, and Chronic HCV Infection, Anti-HCV/HCV RNA Positive, and Increased
3 specimens were unable to be categorized. Risk for HCV Infection
This study was performed on the ARCHITECT i System.
Commercially-
Available Anti- A total of 117 specimens were tested using the ARCHITECT Anti-
Alinity i Anti-HCV HCV Assay HCV assay. Repeatedly reactive samples were further tested by
Number supplemental testing. Of the 117 specimens, 100 were repeatedly
Positive by reactive, and were anti-HCV positive by supplemental testing.
IR RR Supplemental
Testing Specificity a Specificity a Number of Positive
(% of (% of by Supplemental
Category n Total) Total) (% of RR) (95% CI) (95% CI) ARCHITECT Anti-HCV Testinga (%
Blood 2646 6 5 0 99.81% 99.85% Number Repeatedly of Repeatedly
Donors - (0.23) (0.19) (0.00) (2641/2646) (2642/2646) Specimen Category n Reactive (% of Total) Reactive)
Serumb (99.56 - (99.61 - Chronic HCV 50 50 (100.00) 50 (100.00)
99.94) 99.96) Infection
Blood 2477 4 2 0 99.92% 99.92% Anti-HCV/HCV RNA 42 42 (100.00) 42 (100.00)
Donors - (0.16) (0.08) (0.00) (2475/2477) (2475/2477) Positive
Plasma (99.71 - (99.71 - Increased Risk for 25 8 (32.00) 8 (100.00)
99.99) 99.99) HCV Infectionb
Total 5123 10 7 0 99.86% 99.88% Total 117 100 (85.47) 100 (100.00)
Donorsb (0.20) (0.14) (0.00) (5116/5123) (5117/5123)
a A positive result was defined as reactive to two or more gene
(99.72 - (99.75 -
99.95) 99.96) products by an immunoblot assay.
Hospitalized 695 25 25 16 99.11% 99.11% b Category included the following: intravenous drug users (5),
Patients (3.60) (3.60) (64.00) (670/676) (670/676) hemophilia patients (10), men sex men (5), and female prostitutes
(98.08 - (98.08 - (5).
99.67) 99.67)

IR = Initially Reactive, RR = Repeatedly Reactive, CI = Confidence

Interval

6
Seroconversion Sensitivity Other Specimen Conditions or Disease States
To determine the seroconversion sensitivity, 34 panel set of This study was performed on the ARCHITECT i System.
seroconversion panels obtained from commercial vendors were A total of 104 specimens from individuals with other disease states
tested on the Alinity i analyzer using the Alinity i Anti-HCV assay. The or medical conditions unrelated to HCV infection were evaluated.
results were compared to a commercially-available anti-HCV assay Of the 104 specimens, 3 were repeatedly reactive and were anti-
and showed equivalent performance. Representative data from 5 HCV positive by supplemental testing. The results demonstrated a
panels are summarized in the following table. specificity of 100.00%.
Commercially-Available Anti- Number of Positive by
Days Since Alinity i Anti-HCV HCV Assay Supplemental Testinga
Panel ID 1st Bleed Reactive ≥ 1.00 S/CO Reactive ≥ 1.00 S/CO IR (% of RR (% of (% of Repeatedly
6214 0 0.15 0.10 Category Number Tested Total) Total) Reactive)
2 0.09 0.09 Other Specimen 104 3 (2.88) 3 (2.88) 3 (100.00)
Conditions or
8 0.07 0.08 b
Disease States
10 0.51 0.07
16 0.38 0.08 IR = Initially Reactive; RR = Repeatedly Reactive
18 0.07 0.08 a A positive result was defined as reactive to two or more gene

23 0.36 0.38 products by an immunoblot assay.

25 1.14 1.36 b The specimens included the following: anti-CMV positive (5),

32 6.27 6.14 anti-EBV positive (5), anti-HAV positive (5), HBsAg positive (12),
49 11.31 12.08 anti-HIV-1 positive (5), syphilis (5), rheumatoid factor (11), alcoholic
53 12.34 11.76 liver disease (5), anti-HBc positive (5), anti-HTLV-I positive (10),
56 12.39 12.17 anti-HTLV-II positive (2), human anti-mouse antibody positive (10),
6229 0 0.30 0.29 influenza vaccine recipients (5), pregnant women 1st trimester (7), T.
3 0.29 0.29
gondii positive (5), and multiple myeloma (7).
7 0.27 0.26 Interference
10 0.34 0.34 This study was performed on the ARCHITECT i System.
17 1.60 1.75 Potentially Interfering Endogenous Substances
20 2.54 2.55 No qualitative performance differences were observed between
24 4.27 3.94 experimental controls and a minimum of 23 nonreactive or 23 spiked
28 8.40 8.60 reactive specimens tested with elevated levels of the compounds
9047 0 0.05 0.04 listed in the table below.
2 0.05 0.05 Potentially Interfering Substance Interferent Level
10 0.07 0.06 Bilirubin ≤ 20 mg/dL
12 0.04 0.05 Hemoglobin ≤ 500 mg/dL
19 0.05 0.05 Triglycerides ≤ 3000 mg/dL
21 0.06 0.05 Protein ≤ 12 g/dL
28 4.79 4.54
30 9.36 9.73 ll
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Claim for Communicable Disease Donor Screening Tests Using www.abbottdiagnostics.com
Cadaveric Blood Specimens from Donors of Human Cells,
Tissues, and Cellular and Tissue-Based Products (HCT/Ps), Revised February 2020.
November 2004. http://www.fda.gov/BiologicsBloodVaccines/ ©2016, 2020 Abbott Laboratories
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ucm073972.htm Accessed June 29, 2016.
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• A space is used as thousands separator (example: 10 000
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• A period is used to separate the integer part from the fractional
part of a number written in decimal form (example: 3.12%).