6C34-25

en
Anti-HBe
ARCHITECT 6C34-20 6C34
Anti-HBe 6C34-35 G6-0570 / R06
B6C340
Read Highlighted Changes: Revised February 2016.

Package insert instructions must be carefully followed. Reliability of ll

REAGENTS
assay results cannot be guaranteed if there are any deviations from
the instructions in this package insert.
Kit Contents
ARCHITECT Anti-HBe 6C34
ll
NAME NOTE: Some kit sizes are not available in all countries or for use on
ARCHITECT Anti-HBe all ARCHITECT iSystems. Please contact your local distributor.
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INTENDED USE 6C34-25 6C34-20 6C34-35
The ARCHITECT Anti-HBe assay is a chemiluminescent microparticle
immunoassay (CMIA) for the qualitative detection of antibody to 100 400 500
hepatitis B e antigen (anti-HBe) in human serum and plasma and 1 x 6.6 mL 4 x 6.6 mL 1 x 27.0 mL
is indicated as an aid in the diagnosis and monitoring of hepatitis B
viral infection. 1 x 5.9 mL 4 x 5.9 mL 1 x 26.3 mL

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SUMMARY AND EXPLANATION OF THE TEST 1 x 5.9 mL 4 x 5.9 mL 1 x 26.3 mL
Hepatitis B e antigen (HBeAg) and its antibody (anti-HBe) are  Antibody to Hepatitis B e Antigen (mouse,
found in association with hepatitis B viral infection.1 HBeAg is first monoclonal) coated microparticles in phosphate buffer with
detectable in the early phase of hepatitis B viral infection, after the protein (bovine) stabilizer. Minimum concentration: 0.08% solids.
appearance of hepatitis B surface antigen (HBsAg).2 The titers of Preservatives: ProClin 300 and other Antimicrobial Agents.
both antigens rise rapidly during the period of viral replication in
acute infection. Seroconversion from HBeAg to anti-HBe during  Acridinium-labeled antibody to Hepatitis B e Antigen
acute hepatitis B infection is usually indicative of resolution of (mouse, monoclonal) conjugate in MES buffer with protein (bovine)
infection and a reduced level of infectivity. A negative HBeAg result stabilizer. Minimum concentration: 0.08 μg/mL. Preservative: ProClin
may indicate (1) early acute infection before the peak of viral 300.
replication or (2) early convalescence when HBeAg has declined  Hepatitis B e Antigen (recombinant DNA) in
below detectable levels. The presence of anti-HBe serves to TRIS buffer with protein (bovine) stabilizer. Minimum concentration:
distinguish between these two phases.3 A subset of chronic hepatitis 6.7 PEI U/mL. Preservatives: Antimicrobial Agents.
B patients have no detectable HBeAg in serum, but are positive for
anti-HBe; these patients may also be positive for serum hepatitis B Other Reagents
virus DNA.4 ARCHITECT Pre-Trigger Solution containing
Additionally HBe antigen/antibody seroconversion is used as an 1.32% (w/v) hydrogen peroxide.
indicator of virological response when treating patients with chronic
hepatitis B.5 ARCHITECT Trigger Solution containing 0.35 N
sodium hydroxide.
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BIOLOGICAL PRINCIPLES OF THE PROCEDURE ARCHITECT Wash Buffer containing phosphate
The ARCHITECT Anti-HBe assay is a competitive two-step buffered saline solution. Preservatives: antimicrobial agents.
immunoassay for the qualitative detection of anti-HBe in human
serum and plasma using CMIA technology with flexible assay Warnings and Precautions
protocols, referred to as Chemiflex. •
1. Sample, neutralizing reagent, and anti-HBe (mouse, monoclonal) • For In Vitro Diagnostic Use
coated paramagnetic microparticles are combined. The anti-HBe
Safety Precautions
present in the sample binds to the recombinant HBeAg present
in the neutralizing reagent. Unbound recombinant HBeAg is CAUTION: This product requires the handling of human specimens.
available to bind to the anti-HBe coated microparticles. It is recommended that all human-sourced materials be considered
2. After washing, acridinium-labeled anti-HBe conjugate is added to potentially infectious and handled in accordance with the OSHA
create a reaction mixture. Standard on Bloodborne Pathogens. Biosafety Level 2 or other
3. Following another wash cycle, Pre-Trigger and Trigger Solutions appropriate biosafety practices should be used for materials that
are added to the reaction mixture. contain or are suspected of containing infectious agents.6-9
4. The resulting chemiluminescent reaction is measured as relative
light units (RLUs). There is an inverse relationship between the
amount of anti-HBe in the sample and the RLUs detected by the
ARCHITECT iSystem optics.
The presence or absence of anti-HBe in the specimen is determined
by comparing the chemiluminescent signal in the reaction to the
cutoff signal determined from an active calibration.
If the chemiluminescent signal of the reaction is greater than the
cutoff signal, then the sample is considered nonreactive for anti-HBe.
For additional information on system and assay technology, refer to
the ARCHITECT System Operations Manual, Section 3.

1
The following warnings and precautions apply to: / Storage Maximum Additional Storage
Temperature Storage Time Instructions
On board System 30 days Discard after 30 days.
temperature For information on tracking
onboard time, refer to
the ARCHITECT System
WARNING Contain methylisothiazolones. Operations Manual,
H317 May cause an allergic skin reaction. Section 5.
Prevention * Reagents may be stored on or off the ARCHITECT iSystem. If
P261 Avoid breathing mist / vapors / spray. reagents are removed from the system, store them at 2-8°C (with
P272 Contaminated work clothing should not be septums and replacement caps) in an upright position. For reagents
allowed out of the workplace. stored off the system, it is recommended that they be stored in
P280 Wear protective gloves / protective their original trays and boxes to ensure they remain upright. If the
clothing / eye protection. microparticle bottle does not remain upright (with a septum
Response installed) while in refrigerated storage off the system, the reagent
P302+P352 IF ON SKIN: Wash with plenty of water. kit must be discarded. For information on unloading reagents, refer
P333+P313 If skin irritation or rash occurs: Get to the ARCHITECT System Operations Manual, Section 5.
medical advice / attention. Indications of Reagent Deterioration
P362+P364 Take off contaminated clothing and wash When a control value is out of the specified range, it may indicate
it before reuse. deterioration of the reagents or errors in technique. Associated test
Disposal results are invalid, and samples must be retested. Assay recalibration
P501 Dispose of contents / container in may be necessary. For troubleshooting information, refer to the
accordance with local regulations. ARCHITECT System Operations Manual, Section 10.
Safety Data Sheets are available at www.abbottdiagnostics.com or ll
INSTRUMENT PROCEDURE
contact your local representative. The ARCHITECT Anti-HBe assay file must be installed on the
For a detailed discussion of safety precautions during system ARCHITECT iSystem from an ARCHITECT iSystem Assay CD-ROM
operation, refer to the ARCHITECT System Operations Manual, prior to performing the assay.
Section 8. For detailed information on assay file installation and viewing
Reagent Handling and editing assay parameters, refer to the ARCHITECT System
• Do not use reagent kits beyond the expiration date. Operations Manual, Section 2.
• Do not pool reagents within a kit or between kits. NOTE: For details on configuring the ARCHITECT iSystem to use
grayzone interpretations, refer to the ARCHITECT System Operations
• Before loading the reagent kit on the system for the first time, the
Manual, Section 2.
microparticle bottle requires mixing to resuspend microparticles
that may have settled during shipment. For microparticle mixing For information on printing assay parameters, refer to the
instructions, refer to the PROCEDURE, Assay Procedure section ARCHITECT System Operations Manual, Section 5.
of this package insert. For a detailed description of system procedures, refer to the
• Septums MUST be used to prevent reagent evaporation and ARCHITECT System Operations Manual.
contamination and to ensure reagent integrity. Reliability of Alternate Result Units
assay results cannot be guaranteed if septums are not used The default result unit for the ARCHITECT Anti-HBe assay is S/
according to the instructions in this package insert. CO (Sample to Cutoff ratio). An alternate result unit, %Inh (Percent
• To avoid contamination, wear clean gloves when placing a Inhibition), may be selected for reporting results by editing assay
septum on an uncapped reagent bottle. parameter “Result concentration units”, to %Inh. For information
• Once a septum has been placed on an open reagent bottle, on editing the Result concentration units, refer to the ARCHITECT
do not invert the bottle as this will result in reagent leakage System Operations Manual, Section 2.
and may compromise assay results. ll
SPECIMEN COLLECTION AND PREPARATION
• Over time, residual liquids may dry on the septum surface. FOR ANALYSIS
These are typically dried salts and have no effect on assay
efficacy. Specimen Types
For a detailed discussion of handling precautions during system Validated specimen types to be used with this assay:
operation, refer to the ARCHITECT System Operations Manual, Specimen Types Collection Tubes
Section 7. Human serum Serum
Reagent Storage Serum separator tubes
When stored and handled as directed, reagents are stable until the Human plasma Potassium EDTA
expiration date. Sodium citrate
Storage Maximum Additional Storage Sodium heparin
Temperature Storage Time Instructions ACD-B
Unopened/ 2-8°C Until May be used immediately CPDA-1
Opened* expiration after removal from 2-8°C CPD
date storage. Potassium oxalate
Store in upright position.
• Other specimen collection tube types have not been validated
with this assay.
• Performance has not been established for the use of cadaveric
specimens or the use of body fluids other than human serum
and plasma.

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• The instrument does not provide the capability to verify specimen Specimen Storage
type. It is the responsibility of the operator to verify that the Specimen Type Storage Temperature Maximum Storage Time
correct specimen types are used in the assay.
Serum/Plasma 15-30°C ≤ 3 days
Specimen Conditions 2-8°C ≤ 7 days
• Do not use specimens with the following conditions:
• heat-inactivated Specimens may be stored on or off the clot or red blood cells for
• pooled up to 7 days at 2-8°C or off the clot or red blood cells for 3 days at
• grossly hemolyzed 15-30°C.
• obvious microbial contamination Plasma specimens that have been stored at 2-8°C more than
three days without removal from red blood cells should be re-
• This assay was designed and validated for use with human
centrifuged before analysis, to avoid erroneous results.
serum or plasma from individual patient and donor specimens.
Pooled specimens must not be used since the accuracy of their If testing will be delayed more than 7 days, remove serum or plasma
test results has not been validated. from the clot, serum separator, or red blood cells and store frozen
(-20°C or colder).
• To prevent cross contamination, use of disposable pipettes or
pipette tips is recommended. No qualitative differences were observed between experimental
controls and the 23 nonreactive or spiked reactive specimens
• Ensure that complete clot formation in serum specimens has
subjected to 6 freeze/thaw cycles; however, multiple freeze/thaw
taken place prior to centrifugation. Some specimens, especially
cycles should be avoided.
those from patients receiving anticoagulant or thrombolytic
therapy, may exhibit increased clotting time. If the specimen is Specimen Shipping
centrifuged before a complete clot forms, the presence of fibrin • Package and label specimens in compliance with applicable
may cause erroneous results or aspiration errors. state, federal, and international regulations covering the transport
• Specimens from heparinized patients may be partially of clinical specimens and infectious substances.
coagulated, and erroneous results could occur due to the • Do not exceed the storage limitations listed above.
presence of fibrin. To prevent this phenomenon, draw the
specimen prior to heparin therapy. ll
PROCEDURE
• For accurate results, serum and plasma specimens must be free Materials Provided
of fibrin, red blood cells, or other particulate matter. 6C34 ARCHITECT Anti-HBe Reagent Kit
• No qualitative performance differences were observed between Materials Required but not Provided
experimental controls and the 22 nonreactive or the 22 spiked • ARCHITECT Anti-HBe Assay file obtained from the ARCHITECT
reactive specimens tested with elevated levels of hemoglobin iSystem e-Assay CD-ROM found on www.abbottdiagnostics.com.
(≤ 500 mg/dL) or triglycerides (≤ 3,000 mg/dL). • 6C34-01 ARCHITECT Anti-HBe Calibrator
• No qualitative performance differences were observed between • 6C34-10 ARCHITECT Anti-HBe Controls
experimental controls and the 23 nonreactive or the 23 spiked
• ARCHITECT Pre-Trigger Solution
reactive specimens tested with elevated levels of bilirubin
(≤ 20 mg/dL). • ARCHITECT Trigger Solution
• No qualitative performance differences were observed between • ARCHITECT Wash Buffer
experimental controls and the 25 nonreactive or the 25 spiked • ARCHITECT Reaction Vessels
reactive specimens tested with elevated levels of protein • ARCHITECT Sample Cups
(≤ 12 g/dL), or red blood cells (≤ 0.4% v/v). • ARCHITECT Septum
Preparation for Analysis • ARCHITECT Replacement Caps
• Follow the tube manufacturer’s processing instructions for • Pipettes or pipette tips (optional) to deliver the volumes specified
collection tubes. Gravity separation is not sufficient for specimen on the patient or control order screen.
preparation. For information on materials required for maintenance procedures,
• To ensure consistency in results, specimens must be transferred refer to the ARCHITECT System Operations Manual, Section 9.
to a centrifuge tube and centrifuged at ≥ 10,000 RCF (Relative Assay Procedure
Centrifugal Force) for 10 minutes before testing if • Before loading the reagent kit on the system for the first
• they contain red blood cells, clots, or particulate matter, time, the microparticle bottle requires mixing to resuspend
• they require repeat testing, or microparticles that may have settled during shipment. After the
• they were frozen and thawed. first time the microparticles have been loaded, no further mixing
Transfer clarified specimens to a sample cup or secondary tube is required.
for testing. • Invert the microparticle bottle 30 times.
• Mix thawed specimens by inverting 180 degrees from upright • Visually inspect the bottle to ensure microparticles are
and return, for a total of 10 inversion cycles. Visually inspect resuspended. If microparticles are still adhered to the bottle,
the specimens for the absence of stratification. If layering or continue to invert the bottle until the microparticles have
stratification is observed, repeat until specimens are visibly been completely resuspended.
homogeneous. • If the microparticles do not resuspend, DO NOT USE.
Centrifuge at ≥ 10,000 RCF for 10 minutes to remove particulate Contact your local Abbott representative.
matter and to ensure consistency in the results. • Once the microparticles have been resuspended, remove
• Centrifuged specimens with a lipid layer on the top must be and discard the cap. Wearing clean gloves, remove a
transferred to a sample cup or secondary tube. Care must be septum from the bag. Carefully snap the septum onto the
taken to transfer only the clarified specimen without the lipemic top of the bottle.
material. • Load the reagent kit on the ARCHITECT iSystem.
• Inspect all specimens for bubbles. Remove bubbles with an • Verify that all necessary reagents are present.
applicator stick before analysis. Use a new applicator stick for • Ensure that septums are present on all reagent bottles.
each specimen to prevent cross contamination.

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• Order calibration, if necessary. Quality Control Procedures
• For information on ordering calibrations, refer to the The minimum control requirement for the ARCHITECT Anti-HBe assay
ARCHITECT System Operations Manual, Section 6. is that a single sample of both the controls be tested once every
• Order tests. 24 hours each day of use for each reagent lot. If the quality control
• For information on ordering patient specimens and procedures in your laboratory require more frequent use of controls
controls and for general operating procedures, refer to the to verify test results, follow your laboratory-specific procedures.
ARCHITECT System Operations Manual, Section 5. The ARCHITECT Anti-HBe Control values must be within the
• Minimum sample cup volume is calculated by the system acceptable ranges specified in the control package insert. If a
and printed on the Orderlist report. To minimize the effects of control is out of its specified range, the associated test results
evaporation, verify adequate sample cup volume is present prior are invalid and samples must be retested. Recalibration may be
to running the test. indicated.
Maximum number of replicates sampled from the same sample Verification of Assay Claims
cup: 10 For protocols to verify package insert claims, refer to the ARCHITECT
• Priority: System Operations Manual, Appendix B.
Sample volume for first test: 150 µL The ARCHITECT Anti-HBe assay belongs to method group 5.
Sample volume for each additional test from same sample ll
RESULTS
cup: 100 µL The ARCHITECT iSystem calculates the ARCHITECT Anti-HBe
• ≤ 3 hours on board: Calibrator 1 mean chemiluminescent signal (RLU) from 3 replicates
Sample volume for first test: 150 µL and stores the result.
Sample volume for each additional test from same sample Calculation
cup: 100 µL The ARCHITECT iSystem calculates an ARCHITECT Anti-HBe result
• > 3 hours on board: Additional sample volume required. For based on the ratio of the sample RLU to the cutoff RLU (S/CO) for
information on sample evaporation and volumes, refer to the each specimen and control.
ARCHITECT System Operations Manual, Section 5. • Cutoff RLU = Calibrator 1 mean RLU x 0.5
• If using primary or aliquot tubes, use the sample gauge to • The cutoff RLU is stored for each reagent lot calibration.
ensure sufficient patient specimen is present. • S/CO = Sample RLU/Cutoff RLU
• Prepare ARCHITECT Anti-HBe Calibrator and Controls. Example:
• Mix calibrator(s) and controls by gentle inversion (5-10 times) If the Sample RLU = 15000 and the
before use. Cutoff RLU = 30000, then
• Hold bottles vertically and dispense recommended volumes 15000/30000 = 0.50
into each respective sample cup.
S/CO = 0.50
• Recommended volumes:
The ARCHITECT iSystem calculates the percent inhibition (%Inh) of
for each calibrator: 10 drops the sample RLU relative to the Calibrator 1 mean RLU.
for each control: 4 drops Calibrator 1 Mean RLU - Sample RLU
• Load samples. % Inhibition = x 100
Calibrator 1 Mean RLU
• For information on loading samples, refer to the ARCHITECT
System Operations Manual, Section 5. Example:
• Press RUN. If the Sample RLU = 15000 and the
• For additional information on principles of operation, refer to the Calibrator 1 Mean RLU = 60000, then
ARCHITECT System Operations Manual, Section 3. 60000-15000
x 100 = 75
• For optimal performance, it is important to perform routine 60000
maintenance as described in the ARCHITECT System Operations % Inhibition = 75
Manual, Section 9. Perform maintenance more frequently when
required by laboratory procedures. Interpretation of Results
• Specimens with S/CO values > 1.00 are considered nonreactive
Specimen Dilution Procedures
by the ARCHITECT Anti-HBe assay and need not be tested
Specimens cannot be diluted for the ARCHITECT Anti-HBe assay. further.
Calibration • Specimens with S/CO values ≤ 1.00 are considered reactive by
• Test Calibrator 1 in replicates of three. The calibrator should be the ARCHITECT Anti-HBe assay.
priority loaded. • Specimens with %Inh < 50* are considered nonreactive by the
A single sample of each control level must be tested to evaluate ARCHITECT Anti-HBe assay.
the assay calibration. Ensure that assay control values are within • Specimens with %Inh ≥ 50* are considered reactive by the
the ranges specified in the respective control package insert. ARCHITECT Anti-HBe assay.
• Once an ARCHITECT Anti-HBe calibration is accepted and • Samples with S/CO values > 3.0 or %Inh < -50 may be reactive
stored, all subsequent samples may be tested without further for HBeAg and should be tested for HBeAg.
calibration unless: • All initially reactive specimens should be transferred to a
• A reagent kit with a new lot number is used or centrifuge tube, recentrifuged at ≥ 10,000 RCF for 10 minutes
• Controls are out of range. and retested in duplicate. If both retest values are nonreactive,
• For detailed information on how to perform an assay calibration, the specimen must be considered nonreactive for anti-HBe.
refer to the ARCHITECT System Operations Manual, Section 6. If either of the retest values is reactive, the specimen must
be considered repeat reactive for anti-HBe by the criteria of
ARCHITECT Anti-HBe.
• For details on configuring the ARCHITECT iSystem to use
grayzone interpretations, refer to the ARCHITECT System
Operations Manual, Section 2.

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* NOTE: Due to mathematical rounding a sample result of, for Specificity
example, 49.8%Inh equals 50%Inh and is considered reactive by the The ARCHITECT Anti-HBe assay specificity for random blood donor
ARCHITECT Anti-HBe assay. specimens is ≥ 99.5%.
Flags A study on a total of 1310 random blood (serum and plasma) donor
Some results may contain information in the Flags field. For a specimens was performed at two clinical sites. Six specimens
description of the flags that may appear in this field, refer to the were reactive by ARCHITECT Anti-HBe and were also reactive for
ARCHITECT System Operations Manual, Section 5. anti-HBc. The remaining 1304 specimens were nonreactive by

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LIMITATIONS OF THE PROCEDURE
ARCHITECT Anti-HBe. The data from this study are summarized in
Table 2.
• If the anti-HBe results are inconsistent with clinical evidence, The ARCHITECT Anti-HBe assay specificity for hospitalized patient
additional testing is suggested to confirm the result. specimens is > 99.0%.
• For diagnostic purposes, results should be used in conjunction A study on a total of 498 hospitalized patient specimens was
with patient history and other hepatitis markers for diagnosis of performed at one clinical site. Sixty-three specimens were reactive
acute or chronic infection. by ARCHITECT Anti-HBe and were also reactive for anti-HBc. The
• Specimens that have been frozen and thawed and specimens remaining 435 specimens were nonreactive by ARCHITECT Anti-HBe.
containing red blood cells, clots, or particulate matter must be The data from this study are summarized in Table 2.
centrifuged prior to running the assay. Table 2: ARCHITECT Anti-HBe Specificity Results Using Specimens
• Specimens from patients who have received preparations from Random Blood Donors and Hospitalized Patients*
of mouse monoclonal antibodies for diagnosis or therapy Number of
may contain human anti-mouse antibodies (HAMA). Such Number of Reactives by
specimens may show either falsely elevated or depressed values Specimens Initial Repeat Supplemental
when tested with assay kits that employ mouse monoclonal Population Tested Reactive Reactive Testing**
antibodies.10, 11ARCHITECT Anti-HBe reagents contain a Random Blood Donors 1310 6 6 6
component that reduces the effect of HAMA reactive specimens. Hospitalized Patients 498 64 63 63
Additional clinical or diagnostic information may be required to Total 1808 70 69 69
determine patient status.
* Representative performance data are shown. Results obtained in
• Heterophilic antibodies in human serum can react with reagent individual laboratories and with different populations may vary.
immunoglobulins, interfering with in vitro immunoassays. Patients
** Supplemental testing on anti-HBe repeat reactives was performed
routinely exposed to animals or to animal serum products can
with an anti-HBc assay.
be prone to this interference, and anomalous values may be
A study was performed in which a total of 155 specimens from
observed. Additional information may be required for diagnosis.12
individuals with potentially interfering substances and disease states
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SPECIFIC PERFORMANCE CHARACTERISTICS other than HBV (CMV, EBV, anti-HAV, anti-HCV, anti-HIV-1, HSV,
Precision rubella, HBV vaccine recipients, syphilis, urinary tract infections,
The precision of the ARCHITECT Anti-HBe assay across the control rheumatoid factor, anti-nuclear autoantibodies [ANA], toxoplasmosis,
range (0.21 - 2.70 S/CO) is ≤ 10%. A study was performed using a alcoholic cirrhosis, pregnant females, multiple myeloma, multiparous
panel consisting of one nonreactive member, four diluted anti-HBe females, dialysis patients, human anti-mouse antibodies [HAMA])
reactive members, controls, and the calibrator. Two external sites were tested by ARCHITECT Anti-HBe. Seven specimens were
tested two different lots of the controls and the calibrator across two reactive by ARCHITECT Anti-HBe and were also reactive for anti-
reagent lots (every combination), and an internal site tested three HBc. The data from this study are summarized in Table 3.
different lots of controls and calibrator across three reagent lots A study was performed in which 75 specimens from individuals with
(every combination). All panel members were tested in replicates of high risk of blood transmissible infections (intravenous drug users
three per run. The intra-run and inter-run standard deviations (SD) [IVDU], men who have sex with men [MSM], hemophiliacs) were
and percent coefficient of variation (%CV) were analyzed with a tested by ARCHITECT Anti-HBe. Fifteen specimens were reactive by
variance components analysis13 using a mixed analysis of variance ARCHITECT Anti-HBe and were also reactive for anti-HBc. The data
model14. The data from this study are summarized in Table 1. from this study are summarized in Table 3.
Table 1: ARCHITECT Anti-HBe Precision* Table 3: ARCHITECT Anti-HBe Specificity Results Using Potentially
Interfering Substances and High Risk Specimens*
Panel Intra-run Inter-run**
Number of
member Total n Mean S/CO SD %CV SD %CV
Number of Reactives by
Calibrator 1 516 2.00 0.096 4.79 0.097 4.83 Specimens Initial Repeat Supplemental
Negative 516 1.97 0.086 4.38 0.095 4.80 Population Tested Reactive Reactive Testing**
Control Potentially Interfering 155 7 7 7
Positive 516 0.51 0.027 5.29 0.029 5.68 Substances
Control High Risk of Blood 75 15 15 15
Panel 1 204 0.11 0.006 5.64 0.007 6.55 Transmissible Infections
Panel 2 204 0.23 0.008 3.72 0.010 4.48
* Representative performance data are shown. Results obtained in
Panel 3 204 0.47 0.018 3.76 0.022 4.66
individual laboratories and with different populations may vary.
Panel 4 204 0.93 0.044 4.75 0.047 5.04
** Supplemental testing on anti-HBe repeat reactives was performed
Panel 5 204 1.70 0.080 4.69 0.084 4.93
with an anti-HBc assay.
* Representative performance data are shown. Results obtained in Sensitivity
individual laboratories may vary. The ARCHITECT Anti-HBe assay sensitivity is ≥ 99.5%. A study was
** Inter-run variability contains intra-run variability. performed in which a total of 206 specimens, which were pre-
characterized reactive for anti-HBe and anti-HBc, were all reactive
by ARCHITECT Anti-HBe. The data from this study are summarized
in Table 4.

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 Table 4: ARCHITECT Anti-HBe Sensitivity Results Using Specimens
Pre-characterized Reactive for Anti-HBe*
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Key to Symbols
Consult instructions for use
Number of Specimens
Population Tested Reactive
Pre-characterized 206 206 Manufacturer
Anti-HBe Reactives
Sufficient for
* Representative performance data are shown. Results obtained in
individual laboratories and with different populations may vary.
Temperature limitation
The ARCHITECT Anti-HBe assay sensitivity at the cut-off is ≤ 0.45
PEI U/mL.
A study was performed in which a total of 93 specimens from Use by/Expiration date
individuals clinically or serologically classified with different stages of
HBV infection were tested by ARCHITECT Anti-HBe. Seventeen out of
Conjugate
36 acute specimens were reactive and 19 were nonreactive. Out of
57 chronic specimens, 36 were reactive and 21 were nonreactive. Control Number
Assay Comparison In Vitro Diagnostic Medical
A total of 2605 specimens (random blood donors, hospitalized Device
patients, potentially interfering substances, high risk of blood Lot Number
transmissible infections, acute HBV infection, chronic HBV infection, Microparticles
other HBV positives, and seroconversion panels) were tested by
ARCHITECT Anti-HBe and AxSYM Anti-HBe 2.0. The agreement Neutralizing Reagent
between the two methods was 99.19% (2584/2605). Pre-Trigger Solution
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BIBLIOGRAPHY Product of Germany
1. Magnius LO, Lindholm A, Lundin P, et al. A new antigen-antibody Reaction Vessels
system. Clinical significance in long-term carriers of hepatitis B
surface antigen. JAMA 1975;231(4):356-359. Reagent Lot
2. Koff RS. Viral Hepatitis. In: Schiff L, Schiff ER, editors. Diseases of List Number
the Liver. 7th ed. Philadelphia: JB Lippincott, 1993:492-577.
3. Ling C-M, Mushahwar IK, Overby LR, et al. Hepatitis B e-antigen and Replacement Caps
its correlation with other serological markers in chimpanzees. Infect
Immun 1979;24(2):352-356. Sample Cups
4. Bonino F, Rosina F, Rizzetto M, et al. Chronic hepatitis in HBsAg Septum
carriers with serum HBV-DNA and anti-HBe. Gastroenterology
1986;90:1268-1273. Serial number
5. Thomas HC, Hoare JM, Forbes SJ. Chronic hepatitis B: current views Trigger Solution
on the pathogenesis of chronic infection and therapies. In: Margolis
HS, Alter MJ, Liang TJ, Dienstag JL, editors.Viral Hepatitis and Liver Warning: May cause an allergic
Disease. London, UK: International Medical Press; 2002:139-142. reaction.
6. US Department of Labor, Occupational Safety and Health Wash Buffer
Administration, 29 CFR Part 1910.1030, Bloodborne pathogens.
7. US Department of Health and Human Services. Biosafety in The following US Patents are relevant to the ARCHITECT iSystem
Microbiological and Biomedical Laboratories. 5th ed. Washington, DC:
or its components. There are other such patents and patent
US Government Printing Office; December 2009.
8. World Health Organization. Laboratory Biosafety Manual. 3rd ed. applications in the United States and worldwide.
Geneva: World Health Organization; 2004. 5 468 646 5 543 524 5 545 739
9. Clinical and Laboratory Standards Institute (CLSI). Protection 5 565 570 5 669 819 5 783 699
of Laboratory Workers From Occupationally Acquired Infections;
Approved Guideline—Fourth Edition. CLSI Document M29-A4. Wayne, ARCHITECT, AxSYM, and Chemiflex are trademarks of Abbott
PA: CLSI; 2014. Laboratories in various jurisdictions. All other trademarks are property
10. Primus FJ, Kelley EA, Hansen HJ, et al. “Sandwich”-type of their respective owners.
immunoassay of carcinoembryonic antigen in patients receiving
murine monoclonal antibodies for diagnosis and therapy. Clin Chem Abbott GmbH & Co. KG
1988;34(2):261-264. Max-Planck-Ring 2
11. Schroff RW, Foon KA, Beatty SM, et al. Human anti-murine 65205 Wiesbaden
immunoglobulin responses in patients receiving monoclonal antibody Germany 0088
therapy. Cancer Res 1985;45(2):879-885. +49-6122-580
12. Boscato LM, Stuart MC. Heterophilic antibodies: a problem for all
immunoassays. Clin Chem 1988;34(1):27-33.
13. Box GEP, Hunter WG, Hunter JS. Statistics for experimenters; an Customer Service: Contact your local representative
introduction to design, data analysis, and model building. New York, or find country-specific contact information on
NY: John Wiley & Sons, Inc, 1978:510-539, 571–583. www.abbottdiagnostics.com
14. SAS Institute, Inc. SAS Technical Report P-229, SAS/STAT Software:
Changes and enhancements, Release 6.07. Cary, NC: SAS Institute Revised February 2016.
Inc, 1992:289–366. ©2003, 2016 Abbott Laboratories