Elecsys HIV Duo is an immunoassay intended for the in vitro simultaneous qualitative detection and differentiation of HIV‑1 p24 antigen and antibodies to HIV, HIV‑1 (groups M and O) and HIV‑2 in human serum and plasma. Elecsys HIV Duo assay is intended to be used as an aid in the diagnosis of HIV‑1 and/or HIV‑2 infection, including acute or primary HIV‑1 infection. The assay may also be used as an aid in the diagnosis of HIV‑1/HIV‑2 infection in subjects greater than 2 years of age and in pregnant women. Elecsys HIV Duo is not intended for the screening of donors of blood and blood products or human cells, tissues, and cellular and tissue‑based products (HCT/Ps).

Elecsys HIV Duo is an electrochemiluminescence immunoassay “ECLIA” intended for use on the cobas e 402 and cobas e 801 immunoassay analyzers.

Sandwich principle. Total duration of assay: 18 minutes.

2nd incubation: After addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin.

The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell II M. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier.

The effect of the following endogenous substances and pharmaceutical compounds on assay performance was tested. Interferences were tested up to the listed concentrations and no impact on results was observed.

Criterion: Correct assignment of negative and positive samples within a recovery of ± 0.15 COI for negative samples and 80‑120 % for positive samples.

This assay has no biotin interference in serum concentrations up to 1200 ng/mL. Pharmacokinetic studies have shown that serum concentrations of biotin can reach up to 355 ng/mL within the first hour after biotin ingestion for subjects consuming supplements of 20 mg biotin per day

No false negative result due to high‑dose hook effect was found with the Elecsys HIV Duo assay.

In rare cases, interference due to extremely high titers of antibodies to analyte‑specific antibodies, streptavidin or ruthenium can occur. These effects are minimized by suitable test design.

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

A negative test result does not completely rule out the possibility of an infection with HIV. Serum or plasma samples from the very early (pre-seroconversion) phase or the late phase of HIV infection can occasionally yield negative findings. Yet unknown HIV variants can also lead to a negative HIV finding. The presence of antibodies to HIV is not a diagnosis of AIDS.

The reagents (M, R1, R2) in the kit are ready-for-use and are supplied in cobas e packs.

Calibrators

Carefully dissolve the contents of one bottle by adding exactly 1.0 mL of distilled or deionized water and allow to stand closed for 15 minutes to reconstitute. Mix carefully, avoiding foam formation.

Transfer the reconstituted calibrators into the supplied empty labeled snap‑cap bottles.

Unless the entire volume is necessary for calibration on the analyzer, transfer aliquots of the freshly reconstituted calibrators into empty snap‑cap bottles (CalSet Vials). Attach the supplied labels to these additional bottles. Store the aliquots at 2‑8 °C or ‑20 °C (± 5 °C) for later use.

Perform only one calibration procedure per aliquot.

All information required for correct operation is available via the cobas link.

Store at 2‑8 °C.

Do not freeze.

Store the cobas e pack upright in order to ensure complete availability of the microparticles during automatic mixing prior to use.

Store calibrators upright in order to prevent the calibrator solution from adhering to the snap‑cap.

Traceability:

HIVAG: This method has been standardized against the WHO International Standard HIV‑1 p24 Antigen, NIBSC (National Institute for Biological Standards and Control) code 90/636.

AHIV: No internationally accepted standard for anti‑HIV‑1 and anti‑HIV‑2 exists.

Calibration frequency: Calibration must be performed once per reagent lot using HIVDUO Cal1, HIVDUO Cal2, HIVDUO Cal3, HIVDUO Cal4 and fresh reagent (i.e. not more than 24 hours since the cobas e pack was registered on the analyzer).

Recalibration is recommended as follows:

Representative performance data on the cobas e 801 analyzer, as a member of the Elecsys instrument family of analyzers, is given below. Results obtained in individual laboratories may differ.

System Equivalency: The system equivalency between the cobas e 402 analyzer and the cobas e 801 analyzer was demonstrated by evaluating the analytical performance and method comparison study.

The human immunodeficiency virus (HIV), the causative agent of Acquired ImmunoDeficiency Syndrome (AIDS), belongs to the family of retroviruses. HIV can be transmitted through sexual contact, contaminated blood and blood products or from an HIV-infected mother to her child before, during and after birth.
Two types of HIV, called HIV‑1 and HIV‑2, have been identified to date.

HIV p24 antigen in blood specimens of recently infected patients can be detected as early as 2‑3 weeks after infection.

With the Elecsys HIV Duo assay, HIV‑1 p24 antigen (HIV Ag), as well as antibodies to HIV‑1 and HIV‑2 (anti‑HIV) can be detected in parallel with two separate determinations. On the basis of these determinations, the Elecsys HIV Duo main result is subsequently calculated automatically by the analyzer. The subresults HIV Ag and anti‑HIV can be used as an aid in the selection of the confirmation algorithm for reactive samples. The Elecsys HIV Duo assay uses monoclonal antibodies to detect the HIV Ag and recombinant antigens derived from the Env- and Pol-region of HIV‑1 (including group O) and HIV‑2 to detect anti‑HIV antibodies. Repeatedly reactive samples must be confirmed according to recommended confirmatory algorithms.

The cobas e pack HIV Ag (M, R1, R2) is labeled as HIVAG.

The cobas e pack Anti‑HIV (M, R1, R2) is labeled as AHIV.

For in vitro diagnostic use. This test is prescription use only by healthcare professionals. Exercise the normal precautions required for handling all laboratory reagents.

Infectious or microbial waste:
Warning: handle waste as potentially biohazardous material. Dispose of waste according to accepted laboratory instructions and procedures.

Environmental hazards:
Apply all relevant local disposal regulations to determine the safe disposal.

Safety data sheet available for professional user on request.

For USA: Caution: Federal law restricts this device to sale by or on the order of a physician.

This kit contains components classified as follows in accordance with the Regulation (EC) No. 1272/2008:

Warning

Prevention:

Response:

Disposal:

Product safety labeling follows EU GHS guidance.

Contact phone: 1-800-428-2336

All human material should be considered potentially infectious.

The negative calibrators (HIVDUO Cal1 and HIVDUO Cal3) as well as the HIV Ag positive calibrator (HIVDUO Cal2) have been prepared exclusively from the blood of donors tested individually and shown to be free from HBsAg and antibodies to HCV and HIV.

The testing methods use assays that have been approved or cleared by the FDA or that are in compliance with the legal rules applicable to placing in vitro diagnostic medical devices for human use on the market in the European Union.

The serum containing anti‑HIV‑1 (HIVDUO Cal4) was inactivated using β‑propiolactone and UV‑radiation.

However, as no inactivation or testing method can rule out the potential risk of infection with absolute certainty, the material should be handled with the same level of care as a patient specimen. In the event of exposure, the directives of the responsible health authorities should be followed.

Avoid foam formation in all reagents and sample types (specimens, calibrators and controls).

For quality control, use PreciControl HIV Gen II and
PreciControl HIV; HIV‑2+GrpO.

Controls for the various concentration ranges should be run individually at least once every 24 hours when the test is in use, once per cobas e pack, and following each calibration.

The control intervals and limits should be adapted to each laboratory’s individual requirements. Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.

If necessary, repeat the measurement of the samples concerned.

Follow the applicable government regulations and local guidelines for quality control.

Only the specimens listed below were tested and found acceptable.

Serum collected using standard sampling tubes or tubes containing separating gel.

Li‑heparin, Na‑heparin, K₂‑EDTA, K₃‑EDTA, ACD, CPD, CP2D, CPDA, potassium oxalate and Na‑citrate plasma.

Li‑heparin plasma tubes containing separating gel can be used.

Criterion: Correct assignment of negative and positive samples within a recovery of ± 0.2 COI for negative and 80‑120 % for positive samples.

Stable for 7 days at 20‑25 °C, 4 weeks at 2‑8 °C, 3  months at ‑20 °C (± 5 °C). The samples may be frozen up to 5 times.

Sampling devices containing liquid anticoagulants have a dilution effect resulting in lower COI values for individual patient specimens. In order to minimize dilution effects it is essential that respective sampling devices are filled completely according to manufacturer’s instructions.

The sample types listed were tested with a selection of sample collection tubes or systems that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube/collection system manufacturer.

Centrifuge samples containing precipitates and thawed samples before performing the assay.

Do not use heat‑inactivated samples.

Do not use samples and controls stabilized with azide.

Ensure the samples and calibrators are at 20‑25 °C prior to measurement.

Due to possible evaporation effects, samples and calibrators on the analyzers should be analyzed/measured within 2 hours.

Sample stability claims were established by experimental data by the manufacturer or based on reference literature and only for the temperatures/time frames as stated in the method sheet. It is the responsibility of the individual laboratory to use all available references and/or its own studies to determine specific stability criteria for its laboratory.

The performance of the Elecsys HIV Duo assay has not been established with body fluids other than serum and plasma.

Elecsys HIV Duo is an immunoassay intended for the in vitro simultaneous qualitative detection and differentiation of HIV‑1 p24 antigen and antibodies to HIV, HIV‑1 (groups M and O) and HIV‑2 in human serum and plasma. Elecsys HIV Duo assay is intended to be used as an aid in the diagnosis of HIV‑1 and/or HIV‑2 infection, including acute or primary HIV‑1 infection. The assay may also be used as an aid in the diagnosis of HIV‑1/HIV‑2 infection in subjects greater than 2 years of age and in pregnant women. Elecsys HIV duo is not intended for the screening of blood and plasma donors.

Elecsys HIV Duo is an electrochemiluminescence immunoassay “ECLIA” intended for use on the cobas e 801 immunoassay analyzer.

Sandwich principle. Total duration of assay: 18 minutes.

2nd incubation: After addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin.

The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell II M. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier.

The effect of the following endogenous substances and pharmaceutical compounds on assay performance was tested. Interferences were tested up to the listed concentrations and no impact on results was observed.

Criterion: Correct assignment of negative and positive samples within a recovery of ± 0.15 COI for negative samples and 80‑120 % for positive samples.

This assay has no biotin interference in serum concentrations up to 1200 ng/mL. Pharmacokinetic studies have shown that serum concentrations of biotin can reach up to 355 ng/mL within the first hour after biotin ingestion for subjects consuming supplements of 20 mg biotin per day

No false negative result due to high‑dose hook effect was found with the Elecsys HIV Duo assay.

In rare cases, interference due to extremely high titers of antibodies to analyte‑specific antibodies, streptavidin or ruthenium can occur. These effects are minimized by suitable test design.

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

A negative test result does not completely rule out the possibility of an infection with HIV. Serum or plasma samples from the very early (pre-seroconversion) phase or the late phase of HIV infection can occasionally yield negative findings. Yet unknown HIV variants can also lead to a negative HIV finding. The presence of antibodies to HIV is not a diagnosis of AIDS.

The reagents (M, R1, R2) in the kit are ready-for-use and are supplied in cobas e packs.

Calibrators

Carefully dissolve the contents of one bottle by adding exactly 1.0 mL of distilled or deionized water and allow to stand closed for 15 minutes to reconstitute. Mix carefully, avoiding foam formation.

Transfer the reconstituted calibrators into the supplied empty labeled snap‑cap bottles.

Unless the entire volume is necessary for calibration on the analyzer, transfer aliquots of the freshly reconstituted calibrators into empty snap‑cap bottles (CalSet Vials). Attach the supplied labels to these additional bottles. Store the aliquots at 2‑8 °C or ‑20 °C (± 5 °C) for later use.

Perform only one calibration procedure per aliquot.

All information required for correct operation is available via the cobas link.

Store at 2‑8 °C.

Do not freeze.

Store the cobas e pack upright in order to ensure complete availability of the microparticles during automatic mixing prior to use.

Store calibrators upright in order to prevent the calibrator solution from adhering to the snap‑cap.

Traceability:

HIVAG: This method has been standardized against the WHO International Standard HIV‑1 p24 Antigen, NIBSC (National Institute for Biological Standards and Control) code 90/636.

AHIV: No internationally accepted standard for anti‑HIV‑1 and anti‑HIV‑2 exists.

Calibration frequency: Calibration must be performed once per reagent lot using HIVDUO Cal1, HIVDUO Cal2, HIVDUO Cal3, HIVDUO Cal4 and fresh reagent (i.e. not more than 24 hours since the cobas e pack was registered on the analyzer).

Recalibration is recommended as follows:

Representative performance data on the analyzer is given below. Results obtained in individual laboratories may differ.

The human immunodeficiency virus (HIV), the causative agent of Acquired ImmunoDeficiency Syndrome (AIDS), belongs to the family of retroviruses. HIV can be transmitted through sexual contact, contaminated blood and blood products or from an HIV-infected mother to her child before, during and after birth.
Two types of HIV, called HIV‑1 and HIV‑2, have been identified to date.

HIV p24 antigen in blood specimens of recently infected patients can be detected as early as 2‑3 weeks after infection.

With the Elecsys HIV Duo assay, HIV‑1 p24 antigen (HIV Ag), as well as antibodies to HIV‑1 and HIV‑2 (anti‑HIV) can be detected in parallel with two separate determinations. On the basis of these determinations, the Elecsys HIV Duo main result is subsequently calculated automatically by the analyzer. The subresults HIV Ag and anti‑HIV can be used as an aid in the selection of the confirmation algorithm for reactive samples. The Elecsys HIV Duo assay uses monoclonal antibodies to detect the HIV Ag and recombinant antigens derived from the Env- and Pol-region of HIV‑1 (including group O) and HIV‑2 to detect anti‑HIV antibodies. Repeatedly reactive samples must be confirmed according to recommended confirmatory algorithms.

The cobas e pack HIV Ag (M, R1, R2) is labeled as HIVAG.

The cobas e pack Anti‑HIV (M, R1, R2) is labeled as AHIV.

For in vitro diagnostic use.
Exercise the normal precautions required for handling all laboratory reagents.
Disposal of all waste material should be in accordance with local guidelines.
Safety data sheet available for professional user on request.

For USA: Caution: Federal law restricts this device to sale by or on the order of a physician.

This kit contains components classified as follows in accordance with the Regulation (EC) No. 1272/2008:

2-methyl-2H-isothiazol-3-one hydrochloride

Warning

Prevention:

Response:

Disposal:

Product safety labeling follows EU GHS guidance.

Contact phone: 1-800-428-2336

All human material should be considered potentially infectious.

The serum containing anti‑HIV‑1 (HIVDUO Cal4) was inactivated using β‑propiolactone and UV‑radiation.

However, as no inactivation or testing method can rule out the potential risk of infection with absolute certainty, the material should be handled with the same level of care as a patient specimen. In the event of exposure, the directives of the responsible health authorities should be followed.

Avoid foam formation in all reagents and sample types (specimens, calibrators and controls).

For quality control, use PreciControl HIV Gen II and
PreciControl HIV; HIV‑2+GrpO.

Controls for the various concentration ranges should be run individually at least once every 24 hours when the test is in use, once per cobas e pack, and following each calibration.

The control intervals and limits should be adapted to each laboratory’s individual requirements. Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.

If necessary, repeat the measurement of the samples concerned.

Follow the applicable government regulations and local guidelines for quality control.

Only the specimens listed below were tested and found acceptable.

Serum collected using standard sampling tubes or tubes containing separating gel.

Li‑heparin, Na‑heparin, K₂‑EDTA, K₃‑EDTA, ACD, CPD, CP2D, CPDA, potassium oxalate and Na‑citrate plasma.

Li‑heparin plasma tubes containing separating gel can be used.

Criterion: Correct assignment of negative and positive samples within a recovery of ± 0.2 COI for negative and 80‑120 % for positive samples.

Stability: Stable for 7 days at 20‑25 °C, 4 weeks at 2‑8 °C, 3  months at ‑20 °C (± 5 °C). The samples may be frozen up to 5 times.

Sampling devices containing liquid anticoagulants have a dilution effect resulting in lower COI values for individual patient specimens. In order to minimize dilution effects it is essential that respective sampling devices are filled completely according to manufacturer’s instructions.

The sample types listed were tested with a selection of sample collection tubes or systems that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube/collection system manufacturer.

Centrifuge samples containing precipitates and thawed samples before performing the assay.

Do not use heat‑inactivated samples.

Do not use samples and controls stabilized with azide.

Ensure the samples and calibrators are at 20‑25 °C prior to measurement.

Due to possible evaporation effects, samples and calibrators on the analyzers should be analyzed/measured within 2 hours.

Sample stability claims were established by experimental data by the manufacturer or based on reference literature and only for the temperatures/time frames as stated in the method sheet. It is the responsibility of the individual laboratory to use all available references and/or its own studies to determine specific stability criteria for its laboratory.

The performance of the Elecsys HIV Duo assay has not been established with body fluids other than serum and plasma.