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Intended use

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.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

Sandwich principle. Total duration of assay: 18 minutes.

  • 1st incubation: For HIV Ag detection (HIVAG), 30 µL of sample react with biotinylated monoclonal anti‑p24 antibodies and ruthenylated

    FREFTris(2,2'-bipyridyl)ruthenium(II)-complex (Ru(bpy))
    monoclonal anti‑p24 antibodies, to form a sandwich complex. For anti‑HIV detection (AHIV), 30 µL of sample react with biotinylated HIV‑specific recombinant antigens/peptides and ruthenylated
    FREFTris(2,2'-bipyridyl)ruthenium(II)-complex (Ru(bpy))
    HIV‑specific recombinant antigens/peptides, to form a sandwich complex. The incubations are performed in parallel in separate vessels.

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.

  • Results are determined automatically by the software by comparing the electrochemiluminescence signal obtained from the sample with the cutoff value obtained by HIV Ag embedded and anti‑HIV embedded calibrations. The Elecsys HIV Duo result is calculated automatically based on signal to cutoff ratios (cutoff index, COI) from HIV Ag and anti‑HIV.

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "", "Language": "en" }, { "Name": "ExpectedValues", "Value": "", "Language": "en" }, { "Name": "LimitationInterference", "Value": "

Limitations - interference

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.

Endogenous substances

Compound

Concentration tested

Bilirubin

≤ 1129 µmol/L or ≤ 66 mg/dL

Hemoglobin

≤ 0.311 mmol/L or ≤ 500 mg/dL

Intralipid

≤ 2000 mg/dL

Biotin

≤ 4912 nmol/L or ≤ 1200 ng/mL

Human Serum Albumin

≤ 7.0 g/dL

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

LREFGrimsey P, Frey N, Bendig G, et al. Population pharmacokinetics of exogenous biotin and the relationship between biotin serum levels and in vitro immunoassay interference. International Journal of Pharmacokinetics 2017 Sept 14;2(4):247-256.
and up to 1160 ng/mL for subjects after a single dose of 300 mg biotin.
LREFPiketty ML, Prie D, Sedel F, et al. High-dose biotin therapy leading to false biochemical endocrine profiles: validation of a simple method to overcome biotin interference. Clin Chem Lab Med. 2017 May 1;55(6):817-825.

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.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

OrderInformation (Immuno Reagents) + Sum

08836973160

08836973503

300

cobas e 402
cobas e 801

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

Short name

Assay type

To be used for

ACN (application code number)

HIVDUO

cobas e flow

HIV Duo

12016

HIVDUOR

cobas e flow

HIV Duo duplicate repeat

12030

HIVAG

FREFEmbedded application within HIV Duo

HIV Antigen (HIV Ag) embedded application

HIV Duo cobas e flow

11014

AHIV

FREFEmbedded application within HIV Duo

Anti‑HIV embedded application

HIV Duo cobas e flow

11013

", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent handling

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.

", "Language": "en" }, { "Name": "TestDefinition", "Value": "", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

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.

Stability of the cobas e pack:

unopened at 2‑8 °C

up to the stated expiration date

on the cobas e 402 and
cobas e 801 analyzers

16 weeks

Stability of the calibrators:

lyophilized

up to the stated expiration date

reconstituted at 2‑8 °C

3 days

reconstituted at - 20 °C (± 5 °C)

16 weeks (may be frozen 3 times)

on the cobas e 402 and
cobas e 801 analyzers

use only once

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

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

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:

  • after 12 weeks when using the same reagent lot

  • after 28 days when using the same cobas e pack on the analyzer

  • as required: e.g. quality control findings outside the defined limits

", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Specific performance data

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.

", "Language": "en" }, { "Name": "Precision", "Value": "", "Language": "en" }, { "Name": "MethodComparison", "Value": "", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

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.

LREFBarré-Sinoussi F, Chermann JC, Rey F, et al. Isolation of a T-lymphotrophic Retrovirus from a Patient at Risk for Acquired Immune Deficiency Syndrome (AIDS). Science 1983;220:868-871.
,
LREFPopovic M, Sarngadharan MG, Read E, et al. Detection, Isolation and Continuous Production of Cytopathic Retroviruses (HTLV-III) from Patients with AIDS and Pre-AIDS. Science 1984;224:497-500.
,
LREFGallo RC, Salahuddin SZ, Popovic M, et al. Frequent Detection and Isolation of cytopathic Retroviruses (HTLV-III) from Patients with AIDS and Risk for AIDS. Science 1984;224:500-503.
,
LREFClavel F, Guétard D, Brun-Vézinet F, et al. Isolation of a New Human Retrovirus from West Africa Patients with AIDS. Science 1986;233:343-346.
HIV‑1 can be divided into 4 distantly related groups: group M (for main), group N (for non‑M, non‑O), group O (for outlier) and group P (Plantier).
LREFGuertler LG, Hauser PH, Eberle J, et al. A New Subtype of Human Immunodeficiency Virus Type 1 (MVP-5180) from Cameroon. J Virol 1994;68(3):1581-1585.
,
LREFSimon F, Mauclère P, Roques P, et al. Identification of a new human immunodeficiency virus type 1 distinct from group M and group O. Nature Medicine 1998;4(9):1032-1037.
,
LREFPlantier JC, Leoz M, Dickerson JE, et al. A new human immunodeficiency virus derived from gorillas. Nature Medicine 2009;15(8):871-872.
Based on their genetic relationship, 10 different subtypes (A to D, F to H, J, K and L) as well as several circulating recombinant forms (CRFs) have been identified within HIV‑1 group M.
LREFRobertson DL, Anderson JP, Bradac JA, et al. HIV-1 nomenclature Proposal. Science 2000;288(5463):55-56.
,
LREFYamaguchi J, Vallari A, McArthur C, et al. Brief Report: Complete Genome Sequence of CG-0018a-01 Establishes HIV-1 Subtype L. J Acquir Immune Defic Syndr. 2020 Mar 1;83(3):319-322.
The large majority of HIV‑1 infections are caused by viruses belonging to group M, while geographical distribution of subtypes and CRFs within this group varies strongly.
LREFTaylor BS, Hammer SM. The challenge of HIV-1 subtype diversity. N Engl J Med 2008;358:1590-1602.
Due to differences in the sequence of immunodominant epitopes, especially in the envelope proteins of HIV‑1 group M, HIV‑1 group O and HIV‑2, specific antigens are necessary to avoid failure in the detection of an HIV infection by immunoassays.
LREFGuertler LG. Difficulties and strategies of HIV diagnosis. Lancet 1996;348:176-179.
,
LREFVerdier M, Denis F, Leonard G, et al. Comparison of 10 Enzyme Immunoassays for Detection of Antibody to Human Immunodeficiency Virus Type 2 in West African Sera. J Clin Microbiol 1988;26:1000-1004.

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

LREFFiebig EW, Wright DJ, Rawal BD, et al. Dynamics of HIV viremia and antibody seroconversion in plasma donors: implications for diagnosis and staging of primary HIV infection. AIDS 2003;17(13):1871-1879.
,
LREFBusch MP, Lee LL, Satten GA, et al. Time course of detection of viral and serologic markers preceding human immunodeficiency virus type 1 seroconversion: implications for screening of blood and tissue donors. Transfusion 1995;35:91-97.
Anti‑HIV antibodies are detectable in serum from around 4 weeks post infection.
LREFFiebig EW, Wright DJ, Rawal BD, et al. Dynamics of HIV viremia and antibody seroconversion in plasma donors: implications for diagnosis and staging of primary HIV infection. AIDS 2003;17(13):1871-1879.
,
LREFBusch MP, Satten GA. Time course of viremia and antibody seroconversion following human immunodeficiency virus exposure. Am J Med 1997;102(5B):117-124.
The combined detection of HIV p24 antigen and anti‑HIV antibodies in 4th generation HIV screening assays leads to improved sensitivity and therefore a shorter diagnostic window compared to traditional anti‑HIV assays.
LREFWeber B, Fall EH, Berger A, et al. Reduction of Diagnostic Window by New Fourth-generation Human immunodeficiency Virus Screening Assays. Clin Microbiol 1998;36(8):2235-2239.
,
LREFGuertler L, Mühlbacher A, Michl U, et al. Reduction of the diagnostic window with a new combined p24 antigen and human immunodeficiency virus antibody screening assay. Journal of Virological Methods 1998;75:27-38.

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.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

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.

HIVAG

M

Streptavidin-coated microparticles, 1 bottle, 14.1 mL:
Streptavidin-coated microparticles 0.72 mg/mL; preservative.

R1

Anti‑HIV p24-Ab~biotin, 1 bottle, 14.8 mL:
Biotinylated monoclonal anti‑HIV p24 antibodies (mouse) approximately 0.75 mg/L; MES

FREFMES = 2-morpholino-ethane sulfonic acid
buffer 50 mmol/L, pH 6.5; preservative.

R2

Anti‑HIV p24-Ab~Ru(bpy), 1 bottle, 14.8 mL:
Monoclonal anti‑p24 antibodies (mouse) labeled with ruthenium complex approximately 0.75 mg/L; MES

FREFMES = 2-morpholino-ethane sulfonic acid
buffer 50 mmol/L, pH 6.5; preservative.

HIVDUO Cal1

Negative calibrator (lyophilized), 1 bottle for 1.0 mL:
Human serum, non-reactive for anti‑HIV‑1 and anti‑HIV‑2.

HIVDUO Cal2

Positive calibrator (lyophilized), 1 bottle for 1.0 mL:
HIV p24 antigen (E. coli, rDNA) in human serum, non-reactive for anti‑HIV‑1 and anti‑HIV‑2.

AHIV

M

Streptavidin-coated microparticles, 1 bottle, 14.1 mL:
Streptavidin-coated microparticles 0.72 mg/mL; preservative.

R1

HIV‑1/2‑specific recombinant antigens (E. coli)~biotin, HIV‑1/2‑specific synthetic peptides~biotin, 1 bottle, 14.8 mL:
Biotinylated HIV‑1/2‑specific recombinant antigens (E. coli) and biotinylated HIV‑1/2 specific synthetic peptides approximately 0.63 mg/L; TES

FREFTES = 2-[[1,3-dihydroxy-2-(hydroxymethyl)propane-2-yl]amino]ethanesulfonic acid
buffer 40 mmol/L, pH 7.3; preservative.

R2

HIV‑1/2‑specific recombinant antigens (E. coli)~Ru(bpy), HIV‑1/2‑specific synthetic peptides~Ru(bpy), 1 bottle, 14.8 mL:
HIV‑1/2‑specific recombinant antigens (E. coli) and HIV‑1/2‑specific synthetic peptides labeled with ruthenium complex approximately 1.22 mg/L; TES

FREFTES = 2-[[1,3-dihydroxy-2-(hydroxymethyl)propane-2-yl]amino]ethanesulfonic acid
buffer 40 mmol/L, pH 7.3; preservative.

HIVDUO Cal3

Negative calibrator (lyophilized), 1 bottle for 1.0 mL:
Human serum, non-reactive for anti‑HIV‑1 and anti‑HIV‑2.

HIVDUO Cal4

Positive calibrator (lyophilized), 1 bottle for 1.0 mL:
Anti‑HIV‑1 positive human serum (inactivated) in human serum negative for anti‑HIV‑1 and anti‑HIV‑2.

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

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

H317

May cause an allergic skin reaction.

H412

Harmful to aquatic life with long lasting effects.

Prevention:

P261

Avoid breathing dust.

P273

Avoid release to the environment.

P280

Wear protective gloves.

Response:

P333 + P313

If skin irritation or rash occurs: Get medical advice/attention.

P362 + P364

Take off contaminated clothing and wash it before reuse.

Disposal:

P501

Dispose of contents/container to an approved waste disposal plant.

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.

LREFOccupational Safety and Health Standards: Bloodborne pathogens. (29 CFR Part 1910.1030). Fed. Register.
,
LREFDirective 2000/54/EC of the European Parliament and Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work.

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

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Quality control

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.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

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.

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Intended use

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.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

Sandwich principle. Total duration of assay: 18 minutes.

  • 1st incubation: For HIV Ag detection (HIVAG), 30 µL of sample react with biotinylated monoclonal anti‑p24 antibodies and ruthenylated

    FREFTris(2,2'-bipyridyl)ruthenium(II)-complex (Ru(bpy))
    monoclonal anti‑p24 antibodies, to form a sandwich complex. For anti‑HIV detection (AHIV), 30 µL of sample react with biotinylated HIV‑specific recombinant antigens/peptides and ruthenylated
    FREFTris(2,2'-bipyridyl)ruthenium(II)-complex (Ru(bpy))
    HIV‑specific recombinant antigens/peptides, to form a sandwich complex. The incubations are performed in parallel in separate vessels.

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.

  • Results are determined automatically by the software by comparing the electrochemiluminescence signal obtained from the sample with the cutoff value obtained by HIV Ag embedded and anti‑HIV embedded calibrations. The Elecsys HIV Duo result is calculated automatically based on signal to cutoff ratios (cutoff index, COI) from HIV Ag and anti‑HIV.

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "", "Language": "en" }, { "Name": "ExpectedValues", "Value": "", "Language": "en" }, { "Name": "LimitationInterference", "Value": "

Limitations - interference

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.

Endogenous substances

Compound

Concentration tested

Bilirubin

≤ 1129 µmol/L or ≤ 66 mg/dL

Hemoglobin

≤ 0.311 mmol/L or ≤ 500 mg/dL

Intralipid

≤ 2000 mg/dL

Biotin

≤ 4912 nmol/L or ≤ 1200 ng/mL

Human Serum Albumin

≤ 7.0 g/dL

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

LREFGrimsey P, Frey N, Bendig G, et al. Population pharmacokinetics of exogenous biotin and the relationship between biotin serum levels and in vitro immunoassay interference. International Journal of Pharmacokinetics 2017 Sept 14;2(4):247-256.
and up to 1160 ng/mL for subjects after a single dose of 300 mg biotin
LREFPiketty ML, Prie D, Sedel F, et al. High-dose biotin therapy leading to false biochemical endocrine profiles: validation of a simple method to overcome biotin interference. Clin Chem Lab Med. 2017 May 1;55(6):817-825.
.

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.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

OrderInformation (Immuno Reagents) + Sum

08836973190

08836973501

300

cobas e 801

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

Short name

Assay type

To be used for

ACN (application code number)

HIVDUO

cobas e flow

HIV Duo

12016

HIVDUOR

cobas e flow

HIV Duo duplicate repeat

12030

HIVAG

FREFEmbedded application within HIV Duo

HIV Antigen (HIV Ag) embedded application

HIV Duo cobas e flow

11014

AHIV

FREFEmbedded application within HIV Duo

Anti‑HIV embedded application

HIV Duo cobas e flow

11013

", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent handling

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.

", "Language": "en" }, { "Name": "TestDefinition", "Value": "", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

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.

Stability of the cobas e pack:

unopened at 2‑8 °C

up to the stated expiration date

on the cobas e 801 analyzer

16 weeks

Stability of the calibrators:

lyophilized

up to the stated expiration date

reconstituted at 2‑8 °C

3 days

reconstituted at - 20 °C (± 5 °C)

16 weeks (may be frozen 3 times)

on the cobas e 801 analyzer at 20‑25 °C

use only once

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

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

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:

  • after 12 weeks when using the same reagent lot

  • after 28 days when using the same cobas e pack on the analyzer

  • as required: e.g. quality control findings outside the defined limits

", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Specific performance data

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

", "Language": "en" }, { "Name": "Precision", "Value": "", "Language": "en" }, { "Name": "MethodComparison", "Value": "", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

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.

LREFBarré-Sinoussi F, Chermann JC, Rey F, et al. Isolation of a T-lymphotrophic Retrovirus from a Patient at Risk for Acquired Immune Deficiency Syndrome (AIDS). Science 1983;220:868-871.
,
LREFPopovic M, Sarngadharan MG, Read E, et al. Detection, Isolation and Continuous Production of Cytopathic Retroviruses (HTLV-III) from Patients with AIDS and Pre-AIDS. Science 1984;224:497-500.
,
LREFGallo RC, Salahuddin SZ, Popovic M, et al. Frequent Detection and Isolation of cytopathic Retroviruses (HTLV-III) from Patients with AIDS and RISk for AIDS. Science 1984;224:500-503.
,
LREFClavel F, Guétard D, Brun-Vézinet F, et al. Isolation of a New Human Retrovirus from West Africa Patients with AIDS. Science 1986;233:343-346.
HIV‑1 can be divided into 4 distantly related groups: group M (for main), group N (for non‑M, non‑O), group O (for outlier) and group P (Plantier).
LREFGuertler LG, Hauser PH, Eberle J, et al. A New Subtype of Human Immunodeficiency Virus Type 1 (MVP-5180) from Cameroon. J Virol 1994;68(3):1581-1585.
,
LREFSimon F, Mauclère P, Roques P, et al. Identification of a new human immunodeficiency virus type 1 distinct from group M and group O. Nature Medicine 1998;4(9):1032-1037.
,
LREFPlantier JC, Leoz M, Dickerson JE, et al. A new human immunodeficiency virus derived from gorillas. Nature Medicine 2009;15(8):871-872.
Based on their genetic relationship, 10 different subtypes (A to D, F to H, J, K and L) as well as several circulating recombinant forms (CRFs) have been identified within HIV‑1 group M.
LREFRobertson DL, Anderson JP, Bradac JA, et al. HIV-1 nomenclature Proposal. Science 2000;288(5463):55-56.
,
LREFYamaguchi J, Vallari A, McArthur C, et al. Brief Report: Complete Genome Sequence of CG-0018a-01 Establishes HIV-1 Subtype L. J Acquir Immune Defic Syndr. 2020 Mar 1;83(3):319-322.
The large majority of HIV‑1 infections are caused by viruses belonging to group M, while geographical distribution of subtypes and CRFs within this group varies strongly.
LREFTaylor BS, Hammer SM. The challenge of HIV-1 subtype diversity. N Engl J Med 2008;358:1590-1602.
Due to differences in the sequence of immunodominant epitopes, especially in the envelope proteins of HIV‑1 group M, HIV‑1 group O and HIV‑2, specific antigens are necessary to avoid failure in the detection of an HIV infection by immunoassays.
LREFGuertler LG. Difficulties and strategies of HIV diagnosis. Lancet 1996;348:176-179.
,
LREFVerdier M, Denis F, Leonard G, et al. Comparison of 10 Enzyme Immunoassays for Detection of Antibody to Human Immunodeficiency Virus Type 2 in West African Sera. J Clin Microbiol 1988;26:1000-1004.

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

LREFFiebig EW, Wright DJ, Rawal BD, et al. Dynamics of HIV viremia and antibody seroconversion in plasma donors: implications for diagnosis and staging of primary HIV infection. AIDS 2003;17(13):1871-1879.
,
LREFBusch MP, Lee LL, Satten GA, et al. Time course of detection of viral and serologic markers preceding human immunodeficiency virus type 1 seroconversion: implications for screening of blood and tissue donors. Transfusion 1995;35:91-97.
Anti‑HIV antibodies are detectable in serum from around 4 weeks post infection.
LREFFiebig EW, Wright DJ, Rawal BD, et al. Dynamics of HIV viremia and antibody seroconversion in plasma donors: implications for diagnosis and staging of primary HIV infection. AIDS 2003;17(13):1871-1879.
,
LREFBusch MP, Satten GA. Time course of viremia and antibody seroconversion following human immunodeficiency virus exposure. Am J Med 1997;102(5B):117-124.
The combined detection of HIV p24 antigen and anti‑HIV antibodies in 4th generation HIV screening assays leads to improved sensitivity and therefore a shorter diagnostic window compared to traditional anti‑HIV assays.
LREFWeber B, Fall EH, Berger A, et al. Reduction of Diagnostic Window by New Fourth-generation Human immunodeficiency Virus Screening Assays. Clin Microbiol 1998;36(8):2235-2239.
,
LREFGuertler L, Mühlbacher A, Michl U, et al. Reduction of the diagnostic window with a new combined p24 antigen and human immunodeficiency virus antibody screening assay. Journal of Virological Methods 1998;75:27-38.

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.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

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.

HIVAG

M

Streptavidin-coated microparticles, 1 bottle, 14.1 mL:
Streptavidin-coated microparticles 0.72 mg/mL; preservative.

R1

Anti‑HIV p24-Ab~biotin, 1 bottle, 14.8 mL:
Biotinylated monoclonal anti‑HIV p24 antibodies (mouse) approximately 0.75 mg/L; MES

FREFMES = 2-morpholino-ethane sulfonic acid
buffer 50 mmol/L, pH 6.5; preservative.

R2

Anti‑HIV p24-Ab~Ru(bpy), 1 bottle, 14.8 mL:
Monoclonal anti‑p24 antibodies (mouse) labeled with ruthenium complex approximately 0.75 mg/L; MES

FREFMES = 2-morpholino-ethane sulfonic acid
buffer 50 mmol/L, pH 6.5; preservative.

HIVDUO Cal1

Negative calibrator (lyophilized), 1 bottle for 1.0 mL:
Human serum, non-reactive for anti‑HIV‑1 and anti‑HIV‑2.

HIVDUO Cal2

Positive calibrator (lyophilized), 1 bottle for 1.0 mL:
HIV p24 antigen (E. coli, rDNA) in human serum, non-reactive for anti‑HIV‑1 and anti‑HIV‑2.

AHIV

M

Streptavidin-coated microparticles, 1 bottle, 14.1 mL:
Streptavidin-coated microparticles 0.72 mg/mL; preservative.

R1

HIV‑1/2‑specific recombinant antigens (E. coli)~biotin, HIV‑1/2‑specific synthetic peptides~biotin, 1 bottle, 14.8 mL:
Biotinylated HIV‑1/2‑specific recombinant antigens (E. coli) and biotinylated HIV‑1/2 specific synthetic peptides approximately 0.63 mg/L; TES

FREFTES = 2-[[1,3-dihydroxy-2-(hydroxymethyl)propane-2-yl]amino]ethanesulfonic acid
buffer 40 mmol/L, pH 7.3; preservative.

R2

HIV‑1/2‑specific recombinant antigens (E. coli)~Ru(bpy), HIV‑1/2‑specific synthetic peptides~Ru(bpy), 1 bottle, 14.8 mL:
HIV‑1/2‑specific recombinant antigens (E. coli) and HIV‑1/2‑specific synthetic peptides labeled with ruthenium complex approximately 1.22 mg/L; TES

FREFTES = 2-[[1,3-dihydroxy-2-(hydroxymethyl)propane-2-yl]amino]ethanesulfonic acid
buffer 40 mmol/L, pH 7.3; preservative.

HIVDUO Cal3

Negative calibrator (lyophilized), 1 bottle for 1.0 mL:
Human serum, non-reactive for anti‑HIV‑1 and anti‑HIV‑2.

HIVDUO Cal4

Positive calibrator (lyophilized), 1 bottle for 1.0 mL:
Anti‑HIV‑1 positive human serum (inactivated) in human serum negative for anti‑HIV‑1 and anti‑HIV‑2.

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

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

EUH 208

May produce an allergic reaction.

Warning

H317

May cause an allergic skin reaction.

H412

Harmful to aquatic life with long lasting effects.

Prevention:

P261

Avoid breathing dust/fume/gas/mist/vapours/spray.

P273

Avoid release to the environment.

P280

Wear protective gloves.

Response:

P333 + P313

If skin irritation or rash occurs: Get medical advice/attention.

P362 + P364

Take off contaminated clothing and wash it before reuse.

Disposal:

P501

Dispose of contents/container to an approved waste disposal plant.

Product safety labeling follows EU GHS guidance.

Contact phone: 1-800-428-2336

All human material should be considered potentially infectious.

PCW-IM2

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 used assays approved by the FDA or cleared in compliance with the European Directive 98/79/EC, Annex II, List A.

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.

LREFOccupational Safety and Health Standards: Bloodborne pathogens. (29 CFR Part 1910.1030). Fed. Register.
,
LREFDirective 2000/54/EC of the European Parliament and Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work.

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

", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

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.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

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.

", "Language": "en" } ] } } ] }

Elecsys® HIV Duo

IVD For in vitro diagnostic use.
Elecsys<sup>®</sup> HIV Duo
Immunoassay for the qualitative determination of HIV p24 antigen and antibodies to HIV

The human immunodeficiency virus (HIV) is the causative agent of acquired immunodeficiency syndrome (AIDS) and has been a major global burden for over three decades.1,2 HIV is transmitted through sexual contact, contaminated blood and blood products or from an HIV-infected mother to her child before, during and after birth.3 Diagnosis of an HIV infection can be made as early as 2 - 3 weeks after infection, based on the detection of HIV p24 antigen in the blood.4,5 Anti-HIV antibodies are detectable in serum from around 4 weeks post-infection.4,6 

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 calculated automatically by the analyzer. The subresults for HIV Ag and anti-HIV can be used as an aid in the selection of the confirmation algorithm for reactive samples.7

Elecsys® HIV Duo

  • Systems

    cobas e 801 module

  • Testing Time

    18 minutes

  • Test principle

    Double antibody or antigen sandwich immunoassay for the detection of HIV antigen and anti-HIV antibodies, respectively.

  • Calibration

    Individual 2-point calibration for HIV antigen and anti-HIV antibodies

  • Interpretation

    <1.0 = non-reactive 
    ≥1.0 = reactive

  • Sample material

    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 as well as Li-heparin has plasma tubes containing separating gel

  • Sample volume

    60 μL (2 x 30 μL)

  • Onboard stability

    16 weeks

  • Intermediate precision in positive samples

    HIV Ag- 1.5-2.2 CV%
    Anti-HIV- 1.2-1.8 CV%

  • Clinical sensitivity

    100 % (total n = 1549, HIV‑1 confirmed positive pediatric subjects, n=51, HIV‑1 confirmed positive pregnant women subjects, n=59, HIV‑1 group M subtype specimens, n=90, HIV‑1 group O specimens , n=50, and HIV‑1 p24 antigen

  • Clinical specificity

    99.90% (n = 6894 low risk population)

  • Analytical sensitivity

    0.392 IU/mL

References

  1. Maartens, G., Celum, C., Lewin, S.R. (2014). HIV infection: epidemiology, pathogenesis, treatment, and prevention. Lancet 384, 258-71.
  2. Killian, M.S., Levy, J.A. (2011). HIV/AIDS: 30 years of progress and future challenges. Eur J Immunol 41, 3401-11.
  3. Shaw, G.M., Hunter, E. (2012). HIV transmission. Cold Spring Harb Perspect Med. 2:a006965.
  4. Fiebig, E.W., Wright, D.J., Rawal, B.D. et al. (2003). Dynamics of HIV viremia and antibody seroconversion in plasma donors: implications for diagnosis and staging of primary HIV infection. AIDS 17, 1871-9.
  5. Busch, M.P., Lee, L.L., Satten, G.A. et al. (1995). Time course of detection of viral and serologic markers preceding human immunodeficiency virus type 1 seroconversion: implications for screening of blood and tissue donors. Transfusion 35, 91-7.
  6. Guertler, L., Muehlbacher, A., Michl, U. et al. (1998). Reduction of the diagnostic window with a new combined p24 antigen and human immunodeficiency virus antibody screening assay. Journal of Virological Methods 75, 27-38.
  7. HIV Duo Package Insert- 2020-05 V1.0.

Would you like to know more about Elecsys® HIV Duo?

Please submit your information in the following form to be contacted by a Roche representative with more details about Elecsys® HIV Duo.

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