SYSTEM

E
HAVAb-IgG
6C29
B6C290
36-6800/R1

HAVAb-IgG
This package insert must be read carefully prior to use. Package insert instructions must be followed accordingly.
Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package
insert.

© 2004 Abbott / Printed in Germany / ARCHITECT HAVAb-IgG

May 2004

Key to symbols used

List Number Calibrator 1

For In Vitro Diagnostic Use Negative Control

Positive Control
Store at 2-8°C

Assay CD-ROM
CAUTION: Handle human sourced
materials as potentially infectious.
Consult instructions for use. Serial Number
(Infection Risk)
Control Number
Lot Number
Reagent Lot

Expiration Date
Reaction Vessels

Consult instructions for use. Sample Cups

Septum
Legal Manufacturer
Replacement Caps

ABBOTT See REAGENTS section for a full explanation of symbols used in reagent component naming.
Diagnostics Division
1
NAME WARNINGS AND PRECAUTIONS
ARCHITECT® HAVAb-IgG • For In Vitro Diagnostic Use.
INTENDED USE • Package instructions must be followed accordingly. Reliability of assay
The ARCHITECT HAVAb-IgG assay is a chemiluminescent microparticle results cannot be guaranteed if there are any deviations from the
immunoassay (CMIA) for the qualitative detection of IgG antibody to instructions in this package insert.
hepatitis A virus (IgG anti-HAV) in human serum and plasma. The Safety Precautions
ARCHITECT HAVAb-IgG assay is indicated as an aid in the diagnosis
of hepatitis A viral infection or detection of IgG anti-HAV. • CAUTION: This product contains human sourced and/or
SUMMARY AND EXPLANATION OF TEST potentially infectious components. For a specific listing, refer
The ARCHITECT HAVAb-IgG assay determines the presence of IgG to the REAGENTS section of this package insert. No known test
anti-HAV in human serum and plasma. The presence of IgG anti-HAV, method can offer complete assurance that products derived from
with a nonreactive IgM anti-HAV test result, implies past infection with human sources or inactivated microorganisms will not transmit
hepatitis A virus (HAV) or vaccination against HAV.1 infection. Therefore, all human sourced materials should be
considered potentially infectious. It is recommended that these
BIOLOGICAL PRINCIPLES OF THE PROCEDURE reagents and human specimens be handled in accordance with
The ARCHITECT HAVAb-IgG assay is a two-step immunoassay for the the OSHA Standard on Bloodborne Pathogens.2 Biosafety Level
qualitative detection of IgG anti-HAV in human serum and plasma using 23 or other appropriate biosafety practices4,5 should be used
CMIA technology with flexible assay protocols, referred to as Chemiflex®. for materials that contain or are suspected of containing
In the first step, sample, assay diluent, and hepatitis A virus (human) infectious agents. These precautions include, but are not limited
coated paramagnetic microparticles are combined. IgG anti-HAV present to, the following:
in the sample binds to the hepatitis A virus (human) coated microparticles. • Wear gloves when handling specimens or reagents.
After washing, the anti-human IgG acridinium-labeled conjugate that is • Do not pipette by mouth.
added in the second step binds to IgG anti-HAV. Following another wash • Do not eat, drink, smoke, apply cosmetics, or handle contact lenses
cycle, pre-trigger and trigger solutions are added to the reaction mixture. in areas where these materials are handled.
The resulting chemiluminescent reaction is measured as relative light • Clean and disinfect all spills of specimens or reagents using a
units (RLUs). A direct relationship exists between the amount of IgG tuberculocidal disinfectant such as 0.5% sodium hypochlorite, or
anti-HAV in the sample and the RLUs detected by the ARCHITECT i* other suitable disinfectant.6,7
System optics. The presence or absence of IgG anti-HAV in the sample • Decontaminate and dispose of all specimens, reagents, and other
is determined by comparing the chemiluminescent signal in the reaction potentially contaminated materials in accordance with local, state,
to the cutoff signal determined from an ARCHITECT HAVAb-IgG and federal regulations.8,9
calibration. Specimens with signal to cutoff (S/CO) values > 1.00 are • Microparticles and Assay Diluent contain a mixture of: 5-chloro-2-
considered reactive for IgG anti-HAV. Specimens with S/CO values methyl-4-isothiazolin-3-one and 2-methyl-4-isothiazolin-3-one (3:1),
< 1.00 are considered nonreactive. which is a component of ProClin and is classified per applicable
For additional information on system and assay technology, refer to the European Community (EC) Directives as: Irritant (Xi). The following
ARCHITECT System Operations Manual, Section 3. are the appropriate Risk (R) and Safety (S) phrases.
*i = immunoassay R43 May cause sensitization by skin contact.
S24 Avoid contact with skin.
REAGENTS
S35 This material and its container must be disposed
Reagent Kit, 100 Tests of in a safe way.
ARCHITECT HAVAb-IgG Reagent Kit (6C29) S37 Wear suitable gloves.
S46 If swallowed, seek medical advice immediately
• 1 or 4 Bottle(s) (6.6 mL) Microparticles: Hepatitis
and show this container or label.
A virus (human) coated microparticles in TRIS buffer. Minimum
concentration: 0.08% solids. Preservatives: ProClin® 300 and other • ARCHITECT i Trigger Solution contains sodium hydroxide (NaOH)
Antimicrobial Agents. and is classified per applicable European Community (EC) Directives
as: Irritant (Xi). The following are the appropriate Risk (R) and Safety
• 1 or 4 Bottle(s) (5.9 mL) Conjugate: Anti-human IgG
(S) phrases:
(mouse monoclonal) acridinium-labeled conjugate in MES buffer with
protein (bovine) stabilizer. Minimum concentration: 0.01 µg/mL. R41 Risk of serious damage to eyes.
Preservatives: Antimicrobial Agents. S25 Avoid contact with eyes.
S26 In case of contact with eyes, rinse immediately
• 1 or 4 Bottle(s) (10.0 mL) Assay Diluent: HAVAb-IgG with plenty of water and seek medical advice.
Assay Diluent containing protein (goat) stabilizer in TRIS buffer. S35 This material and its container must be disposed
Preservatives: ProClin 300 and other Antimicrobial Agents. of in a safe way.
S36/39 Wear suitable protective clothing and eye/face
Other Reagents
protection.
ARCHITECT i Pre-Trigger Solution S46 If swallowed, seek medical advice immediately
• Pre-Trigger Solution containing 1.32% and show this container or label.
(w/v) hydrogen peroxide. • Information for European customers: For product not classified
ARCHITECT i Trigger Solution as dangerous per European Directive 1999/45/EC - Safety data
sheet available for professional user on request.
• Trigger Solution containing 0.35M sodium • For a detailed discussion of safety precautions during system
hydroxide. operation, refer to the ARCHITECT System Operations Manual,
ARCHITECT i Wash Buffer Section 8.
• Wash Buffer containing phosphate buffered saline
solution. Preservative: Antimicrobial Agents.

2
Handling Precautions SPECIMEN COLLECTION AND PREPARATION FOR
• Do not use reagent kits beyond the expiration date. ANALYSIS
• Do not pool reagents within a kit or between reagent kits. • Human serum (including serum collected in serum separator tubes)
• Prior to loading the ARCHITECT HAVAb-IgG Reagent Kit on the or plasma collected in potassium EDTA, sodium citrate, sodium
system for the first time, the microparticle bottle requires mixing to heparin, ACD, CPDA-1, and CPD may be used in the ARCHITECT
resuspend microparticles that have settled during shipment. For HAVAb-IgG assay. Other anticoagulants have not been validated for
microparticle mixing instructions, refer to the PROCEDURE, Assay use with the ARCHITECT HAVAb-IgG assay. Follow the manufacturer’s
Procedure, section of this package insert. instructions for processing serum or plasma collection tubes.
• Septums MUST be used to prevent reagent evaporation and • The ARCHITECT i System does not provide the capability to verify
contamination, and to ensure reagent integrity. Reliability of specimen type. It is the responsibility of the operator to verify that the
assay results cannot be guaranteed if septums are not used correct specimen types are used in the ARCHITECT HAVAb-IgG
according to the instructions in this package insert. assay.
• To avoid contamination, wear clean gloves when placing a • Use caution when handling patient specimens to prevent cross
septum on an uncapped reagent bottle. contamination. Use of disposable pipettes or pipette tips is
• When handling conjugate vials, change gloves that have contacted recommended.
human serum or plasma, since introduction of human IgG will result • This assay was designed and validated for use with human serum or
in a neutralized conjugate. plasma from individual patient and donor specimens. Pooled
• Prior to placing the septum on an uncapped reagent bottle, squeeze specimens must not be used since the accuracy of their test results
the septum in half to confirm that the slits are open. If the slits appear have not been validated.
sealed, continue to gently squeeze the septum to open the slits. • Do not use heat-inactivated specimens.
• Once a septum has been placed on an open reagent bottle, do not • Do not use grossly hemolyzed specimens.
invert the bottle as this will result in reagent leakage and may • Specimens with obvious microbial contamination should not be used.
compromise assay results. • Performance has not been established using cadaver specimens or
• Over time, residual liquids may dry on the septum surface. These body fluids other than human serum or plasma.
are typically dried salts, which have no effect on assay efficacy. • For optimal results, inspect all specimens for bubbles. Remove
• For a detailed discussion of handling precautions during system bubbles with an applicator stick prior to analysis. Use a new applicator
operation, refer to the ARCHITECT System Operations Manual, stick for each specimen to prevent cross contamination.
Section 7. • Ensure that complete clot formation in serum specimens has taken
Storage Instructions place prior to centrifugation. Some specimens, especially those from
patients receiving anticoagulant or thrombolytic therapy, may exhibit
• The ARCHITECT HAVAb-IgG Reagent Kit must be increased clotting time. If the specimen is centrifuged before a
stored at 2-8°C in an upright position and may be used complete clot forms, the presence of fibrin may cause erroneous
immediately after removal from 2-8°C storage. results or aspiration errors.
• When stored and handled as directed, reagents are stable until the • Specimens from heparinized patients may be partially coagulated
expiration date. and erroneous results could occur due to the presence of fibrin. To
• The ARCHITECT HAVAb-IgG Reagent Kit may be stored on board prevent this phenomenon, draw the specimen prior to heparin therapy.
the ARCHITECT i System for a maximum of 30 days. After 30 days, • For accurate results, serum and plasma specimens should be free of
the reagent kit must be discarded. For information on tracking onboard fibrin, red blood cells, or other particulate matter.
time, refer to the ARCHITECT System Operations Manual, Section 5. • Gravity separation is not sufficient for specimen preparation.
• Reagents may be stored on or off the ARCHITECT i System. If Specimens must be separated from clots or red blood cells using
reagents are removed from the system, store them at 2-8°C (with centrifugation, as recommended by the tube manufacturer.
septums and replacement caps) in an upright position. For reagents • After specimens have been processed according to the collection
stored off the system, it is recommended that they be stored in their tube manufacturer’s instructions, they must be transferred to a
original trays and boxes to ensure they remain upright. If the centrifuge tube and centrifuged at > 10,000 RCF (Relative Centrifugal
microparticle bottle does not remain upright (with a septum Force) for 10 minutes if one or more of the following has occurred:
installed) while in refrigerated storage off the system, the • they contain red blood cells, clots, or particulate matter
reagents must be discarded. After reagents are removed from the • they require repeat testing
system, you must initiate a scan to update the onboard stability timer. Transfer clarified specimens to a sample cup or secondary tube for
Indications of Reagent Deterioration testing.
When a control value is out of the specified range, it may indicate • Multiple freeze/thaw cycles of specimens should be avoided.
deterioration of the reagents or errors in technique. Associated test Mix thawed specimens by inverting 10 times. Visually inspect
results are invalid and samples must be retested. Assay recalibration the specimens for the absence of stratification. If layering or
may be necessary. For troubleshooting information, refer to the stratification is observed repeat until specimens are visibly
ARCHITECT System Operations Manual, Section 10. homogeneous.
Centrifuge at > 10,000 RCF for 10 minutes to remove particulate
INSTRUMENT PROCEDURE matter and ensure consistency in the results.
• The ARCHITECT HAVAb-IgG assay file must be installed on the • Centrifuged specimens with a lipid layer on the top must be transferred
ARCHITECT i System from the ARCHITECT i Assay CD-ROM prior to a sample cup or secondary tube. Care must be taken to transfer
to performing the assay. For detailed information on assay file only the clarified specimen without the lipemic material.
installation and on viewing and editing assay parameters, refer to • Specimens may be stored on or off the clot or red blood cells for up
the ARCHITECT System Operations Manual, Section 2. to 14 days at 2-8°C. If testing will be delayed more than 14 days,
• For information on printing assay parameters, refer to the ARCHITECT remove serum or plasma from the clot, serum separator, or red blood
System Operations Manual, Section 5. cells and store frozen at -10°C or colder.
• For a detailed description of system procedures, refer to the • No qualitative performance differences were observed between
ARCHITECT System Operations Manual. experimental controls and 21 nonreactive or 21 spiked reactive
specimens subjected to 6 freeze/thaw cycles; however, multiple
freeze/thaw cycles should be avoided.

3
• No qualitative performance differences were observed between • < 3 hours on board: 150 µL for the first ARCHITECT HAVAb-IgG
experimental controls and 19 nonreactive or 19 spiked reactive test plus 25 µL for each additional ARCHITECT HAVAb-IgG test
specimens tested with elevated levels of bilirubin (< 20 mg/dL), from the sample cup.
triglycerides (< 3,000 mg/dL), protein (< 12 g/dL), or hemoglobin • > 3 hours on board: additional sample volume is required. For
(< 500 mg/dL). additional information on sample evaporation and volumes, refer
• No qualitative performance differences were observed between to the ARCHITECT System Operations Manual, Section 5.
experimental controls and 21 nonreactive or 21 spiked reactive • If using primary or aliquot tubes, use the sample gauge to ensure
specimens tested with elevated levels of red blood cells (< 0.4% v/v). sufficient sample volume is present.
• Before shipping specimens, it is recommended that specimens be • Prepare calibrator and controls.
removed from the clot, serum separator, or red blood cells. When • ARCHITECT HAVAb-IgG Calibrator 1 and Controls should be mixed
shipped, specimens must be packaged and labeled in compliance by gentle inversion 5-10 times prior to use.
with applicable state, federal, and international regulations covering • To obtain the recommended volume requirements for the
the transport of clinical specimens and infectious substances. ARCHITECT HAVAb-IgG Calibrator 1 and Controls, hold the bottles
Specimens may be shipped at 2-8°C (wet ice) or at -10°C or colder vertically and dispense 4 drops of calibrator or 4 drops of each
(dry ice). Do not exceed the storage time limitations identified in control into each respective sample cup.
this section of the package insert. • Load samples.
• For information on loading samples, refer to the ARCHITECT
PROCEDURE System Operations Manual, Section 5.
Materials Provided: • Press RUN. The ARCHITECT i System performs the following
• 6C29 ARCHITECT HAVAb-IgG Reagent Kit functions:
• Moves the sample to the aspiration point.
Materials Required but not Provided:
• Loads a reaction vessel (RV) into the process path.
• ARCHITECT i System
• Aspirates and transfers an aliquot of sample into the RV.
• ARCHITECT i • Moves RV one position.
• 6C29-01 ARCHITECT HAVAb-IgG Calibrator • Aspirates and transfers aliquots of assay diluent and microparticles
to the RV containing sample.
• 6C29-10 ARCHITECT HAVAb-IgG Controls
• Mixes, incubates, and washes the reaction mixture.
• ARCHITECT i • Adds conjugate to the RV.
• ARCHITECT i • Mixes, incubates, and washes the reaction mixture.
• Adds pre-trigger and trigger Solutions.
• ARCHITECT i • Measures chemiluminescent emission to detect the presence of
• ARCHITECT i IgG anti-HAV in the sample.
• Aspirates contents of RV to liquid waste and unloads RV to solid
• ARCHITECT i
waste.
• ARCHITECT i • Calculates the result.
• ARCHITECT i • For optimal performance of the ARCHITECT i System , it is important
to follow the routine maintenance procedures defined in the
• Pipettes or pipette tips (optional) to deliver the volumes specified on ARCHITECT System Operations Manual, Section 9. If your laboratory
the patient or control order screen. requires more frequent maintenance, follow those procedures.
• For information on materials required for maintenance procedures,
refer to the ARCHITECT System Operations Manual, Section 9. Specimen Dilution Procedures
Assay Procedure Specimens cannot be diluted for the ARCHITECT HAVAb-IgG assay.
• Before loading the ARCHITECT HAVAb-IgG Reagent Kit on the Calibration
system for the first time, the microparticle bottle requires mixing to • To perform an ARCHITECT HAVAb-IgG calibration, test Calibrator 1
resuspend microparticles that have settled during shipment: in replicates of three by ordering a Calibration for the ARCHITECT
• Invert the microparticle bottle 30 times. HAVAb-IgG assay from the Orders menu. A single sample of each
• Visually inspect the bottle to ensure microparticles are ARCHITECT HAVAb-IgG Control level must be tested to evaluate
resuspended. If microparticles remain adhered to the bottle, the assay calibration. Ensure that assay control values are within the
continue inverting the bottle until the microparticles have been concentration ranges specified in the control package insert. Calibrator
completely resuspended. 1 should be priority loaded.
• If the microparticles do not resuspend, DO NOT USE. Contact • Once an ARCHITECT HAVAb-IgG calibration is accepted and stored,
your local Abbott Laboratories representative. all subsequent samples may be tested without further calibration
• Once the microparticles have been resuspended, remove and unless one or both of the following occur:
discard the cap. Wearing clean gloves, remove a septum from the • A reagent kit with a new lot number is used
bag. Squeeze the septum in half to confirm that the slits are open. • Controls are out of range
Carefully snap the septum onto the top of the bottle. • For detailed information on how to perform an assay calibration, refer
• Order calibration, if necessary. to the ARCHITECT System Operations Manual, Section 6.
• For information on ordering calibrations, refer to the ARCHITECT
System Operations Manual, Section 6. QUALITY CONTROL PROCEDURES
• Order tests. The recommended control requirement for the ARCHITECT HAVAb-IgG
• For information on ordering patient specimens and controls and assay is that a single sample of each control be tested once every
general operating procedures, refer to the ARCHITECT System 24 hours each day of use for each reagent lot. If the quality control
Operations Manual, Section 5. procedures in your laboratory require more frequent use of controls to
• Load the ARCHITECT HAVAb-IgG Reagent Kit on the verify test results, follow your laboratory-specific procedures.
ARCHITECT i System. The ARCHITECT HAVAb-IgG Control values must be within the
• Verify that all necessary reagents are present. Ensure that septums acceptable ranges specified in the control package insert. If a control is
are present on all reagent bottles. out of its specified range, the associated test results are invalid and
• The minimum sample cup volume is calculated by the system and is must be retested. Recalibration may be indicated.
printed on the Orderlist report. No more than 10 replicates may be
sampled from the same sample cup. To minimize the effects of Verification of Assay Claims
evaporation, verify adequate sample cup volume is present prior to For protocols to verify package insert claims, refer to the ARCHITECT
running the test. System Operations Manual, Appendix B. The ARCHITECT HAVAb-IgG
• Priority: 75 µL for the first ARCHITECT HAVAb-IgG test plus 25 µL assay belongs to method group 5.
for each additional ARCHITECT HAVAb-IgG test from the same
sample cup.

4
RESULTS Table 1
Calculation ARCHITECT HAVAb-IgG Precision
The ARCHITECT i System calculates cutoff RLU (CO) from the mean Panel Intra-assay Inter-assaya
RLU value of three Calibrator 1 replicates and stores the result. Member n Mean SD %CV SD %CV
• Cutoff RLU = Calibrator 1 mean RLU Value x 0.29 Calibrator 1 (RLUs) 324 7758 478.5 6.2 488.6 6.3
• The cutoff RLU is stored for each reagent lot calibration. Negative Control (S/CO) 756 0.13 0.020 16.12 0.020 16.12
The ARCHITECT i System then calculates a result based on the ratio Positive Control (S/CO) 972 2.32 0.141 6.08 0.164 7.05
of the sample RLU to the cutoff RLU (S/CO) for each specimen and Diluted Specimen (S/CO) 432 1.72 0.101 5.87 0.107 6.23
control. a Inter-assay variability contains
intra-assay variability.
• Example If the sample RLU = 4730 and the * Representative performance data are shown. Results obtained at individual
Cutoff RLU = 1920 laboratories may vary.
4730/1920 = 2.46
Specificity
S/CO = 2.46
• The ARCHITECT HAVAb-IgG assay demonstrated a specificity of
Interpretation of Results > 99.17%* in a study testing serum and plasma specimens from the
ARCHITECT HAVAb-IgG Results following populations:
Results
• Randomly selected blood donors (BD)
(S/CO) Interpretation
• Randomly selected hospitalized patients (HP)
The testing was performed at one clinical site and one internal site.
< 1.00 Nonreactive (NR)
Of 1855 specimens initially tested, 879 specimens were reactive by
> 1.00 Reactive (R)
both ARCHITECT HAVAb-IgG and AxSYM HAVAB 2.0. In addition,
Flags 8 other specimens were found to be reactive by supplemental testing.
Therefore, these 887 specimens were considered true IgG anti-HAV
• Some results may contain information in the Flags field. For a
reactives and were excluded from the specificity calculation. The data
description of the flags that may appear in this field, refer to the
from the remaining 968 specimens from this study are summarized
ARCHITECT System Operations Manual, Section 5.
in Table 2.*
LIMITATIONS OF THE PROCEDURE Table 2
• If the IgG anti-HAV results are inconsistent with clinical evidence, ARCHITECT HAVAb-IgG Specificity Results
additional testing is suggested to confirm the result.
False Specificity Specificity
• For diagnostic purposes, results should be used in conjunction with
Population n Reactives (%) 95% CIa
patient history and other hepatitis markers for diagnosis of acute or
chronic infection. BD 474 3 99.37 98.16 - 99.87
• Specimens must be centrifuged prior to running the assay if one or HP 494 5 98.99 97.65 - 99.67
more of the following has occurred: Total 968 8 99.17 98.38 - 99.64
• they contain red blood cells, clots, or particulate matter a CI = Confidence Interval
• they require repeat testing
* Representative performance data are shown. Results obtained at individual
• Do not use heat-inactivated specimens. laboratories may vary.
• Do not use grossly hemolyzed specimens.
• Specimens with obvious microbial contamination should not be used. • Of 210 specimens initially tested from populations of interfering
• Performance has not been established using cadaver specimens or substances (IS) and patients at increased risk for HAV infection (HR),
body fluids other than human serum or plasma. 118 specimens were reactive by both ARCHITECT HAVAb-IgG and
• Specimens from heparinized patients may be partially coagulated AxSYM HAVAB 2.0. These 118 specimens were considered true IgG
and erroneous results could occur due to the presence of fibrin. To anti-HAV reactives and were excluded from the study. The data from
prevent this phenomenon, draw the specimen prior to heparin therapy. the remaining 92 specimens from this study are summarized in Table 3.*
• Specimens from patients who have received preparations of mouse Table 3
monoclonal antibodies for diagnosis or therapy may contain human ARCHITECT HAVAb-IgG
anti-mouse antibodies (HAMA). Such specimens may show either Potentially Interfering Substances and High Risk Specimens
falsely elevated or depressed values when tested with assay kits
Population n Initial Reactives Repeat Reactives
that employ mouse monoclonal antibodies. 10,11 ARCHITECT
HAVAb-IgG reagents contain a component that reduces the effect of ISb 48 4 4c
HAMA reactive specimens. Additional clinical or diagnostic information HRd 44 3 3e
may be required to determine patient status. b Specimens containing the following potentially interfering substances were
• Heterophilic antibodies in human serum can react with reagent evaluated for cross-reactivity by ARCHITECT HAVAb-IgG:
immunoglobulins, interfering with in vitro immunoassays.12 Patients • CMV-IgG • CMV-IgM
routinely exposed to animals or to animal serum products can be • Chronic HBV • HCV
prone to this interference and anomalous values may be observed. • Recovered HBV • HIV-1
Additional information may be required for diagnosis. • HSV • Flu vaccines
SPECIFIC PERFORMANCE CHARACTERISTICS • Alcoholic cirrhosis • Antinuclear antibodies (ANA)
• Elevated IgM • Rheumatoid factor
Precision
• Elevated IgG • HAMA
The ARCHITECT HAVAb-IgG assay demonstrated imprecision c The repeat reactives in the IS population were from 1 HIV-1 specimen, 1
of < 10% for Calibrator 1 and Positive Control in a study where a panel, HAMA specimen, and 2 rheumatoid factor specimens.
consisting of one diluted IgG anti-HAV reactive specimen, three control d The HR population included specimens from hemophilia patients,
lots, and three calibrator lots, was tested. The study was performed at intravenous drug users, and men who have had sex with men.
one external site, running one ARCHITECT i System (and only one lot e The repeat reactives in the HR population were from 1 intravenous drug
of negative control), and one internal site, running two ARCHITECT i user specimen and 2 hemophiliac specimens.
Systems. Both sites tested all panel members with three reagent lots * Representative performance data are shown. Results obtained at individual
and evaluated them with each calibrator lot. Each combination of laboratories may vary.
instruments, control lots, calibrator lots, and reagent lots was tested in Sensitivity
four runs. The controls and calibrator were tested in replicates of three
• The ARCHITECT HAVAb-IgG assay demonstrated a sensitivity of
on each run. The diluted IgG anti-HAV reactive specimen was tested in
> 98% in a study testing serum and plasma specimens drawn from
replicates of four on each run. The intra-run and inter-run standard
individuals vaccinated against HAV and patients who had recovered
deviation (SD) and percent coefficient of variation (%CV) were analyzed
from acute HAV infection. The data from this study are summarized
with a variance components analysis13 using a mixed analysis of
in Table 4.*
variance model.14 The data from this study are summarized in Table 1.*

5
 Table 4 10. Primus FJ, Kelley EA, Hansen HJ, Goldbery DM. “Sandwich”-type
ARCHITECT HAVAb-IgG Sensitivity Results immunoassay of carcinoembryonic antigen in patients Receiving
Population n Reactive Nonreactive Murine Monoclonal Antibody Therapy. Clin Chem 1988;34:261–4.
11. Schroff RW, Foon KA, Beatty SM, Oldham RK, Morgan AC Jr.
Vaccinated 101 101 0 Human anti-murine immunoglobulin responses in patients receiving
Recovered from HAV Infection 45 45 0 monoclonal antibody therapy. Cancer Res 1985;45:879–85.
12. Boscato LM and Stuart MC. Heterophilic antibodies; a problem for
• Testing by ARCHITECT HAVAb-IgG and ARCHITECT HAVAb-IgM
all immunoassays. Clin Chem 1988;34(1):27–33.
was performed on serial bleed panels. The reactive ARCHITECT
13. Box GEP, Hunter WG, Hunter JS. Statistics for experimenters; an
HAVAb-IgG result is indicative of seroconversion from IgM anti-HAV
introduction to design, data analysis, and model building. New York,
to IgG anti-HAV.
NY: John Wiley & Sons, Inc, 1978:510-39, 571–83.
* Representative data for one of the panels is provided in Figure 1.* 14. SAS Institute, Inc. SAS® Technical Report P-229, SAS/STAT®
Figure 1 Software: Changes and enhancements, Release 6.07. Cary, NC:
SAS Institute, 1992:289–366.

The following U.S. Patents are relevant to the ARCHITECT i System or

its components. There are other such patents and patent applications
in the United States and worldwide.
5 468 646 5 543 524 5 545 739
5 565 570 5 669 819 5 783 699

ARCHITECT, AxSYM, and Chemiflex are registered trademarks of Abbott

Laboratories.
ProClin® is a registered trademark of the Rohm and Haas Company or
one of its subsidiaries or affiliates.
SAS® and SAS/STAT® are registered trademarks of SAS Institute, Inc.

For additional product information, please contact your local customer

service organization.

* Representative performance data are shown. Results obtained at individual

laboratories may vary.

BIBLIOGRAPHY
1. CDC. Prevention of hepatitis A through active or passive
immunization: Recommendations of the advisory committee on
immunization practices (ACIP). MMWR 1999;48(RR12):1-37.
2. US Department of Labor, Occupational Safety and Health
Administration, 29 CFR Part 1910.1030, Occupational exposure
to bloodborne pathogens; final rule. Federal Register
1991;56(235):64175-82.
3. US Department of Health and Human Services. Biosafety in
Microbiological and Biomedical Laboratories. HHS Publication No.
(CDC) 93-8395. Washington, DC: US Government Printing Office,
May 1999.
4. World Health Organization. Laboratory Biosafety Manual. Geneva:
World Health Organization; 1993.
5. National Committee for Clinical Laboratory Standards. Protection
of Laboratory Workers from Occupationally Acquired Infection:
Approved Guideline-Second Edition. NCCLS Document M29-A2.
Wayne, PA: NCCLS, 2001.
6. CDC. Guidelines for prevention of transmission of human
immunodeficiency virus and hepatitis B virus to health-care and
public-safety workers. MMWR 1989;38(S-6):16.
7. Sehulster LM, Hollinger FB, Dreesman GR, et al. Immunological
and biophysical alteration of hepatitis B virus antigens by sodium
hypochlorite disinfection. Appl Envir Microbiol 1981;42(5):762–7.
8. National Committee for Clinical Laboratory Standards. Clinical
Laboratory Waste Management: Approved Guideline-Second
Edition. NCCLS Document GP5-A2. Wayne, PA: NCCLS,
2002;22(3):1-23, 32-44.
9. US Environmental Protection Agency. EPA Guide for
Infectious Waste Management. Publication No. EPA/530-SW-86-
014. Washington, DC: US Environmental Protection Agency;
1986:1-1–5-5, R1-R3, A1-A24.