07229542500V4.

Elecsys HIV Duo

07229542190 07229542500 300 cobas e 801

English ▪ 1st incubation: For HIV Ag detection (HIVAG), 30 µL of sample react
with biotinylated monoclonal anti‑p24 antibodies and ruthenylateda)
System information monoclonal anti‑p24 antibodies, to form a sandwich complex. For
Short name Assay type To be used for anti‑HIV detection (AHIV), 30 µL of sample react with biotinylated
HIV‑specific recombinant antigens/peptides and ruthenylateda)
HIVDUO cobas e flow HIV Duo HIV‑specific recombinant antigens/peptides, to form a sandwich
HIVDUOR cobas e flow HIV Duo duplicate complex. The incubations are performed in parallel in separate vessels.
repeat ▪ 2nd incubation: After addition of streptavidin-coated microparticles, the
complex becomes bound to the solid phase via interaction of biotin and
HIVAG HIV Antigen (HIV Ag) HIV Duo cobas e flow streptavidin.
embedded application
▪ The reaction mixture is aspirated into the measuring cell where the
AHIV Anti‑HIV embedded HIV Duo cobas e flow microparticles are magnetically captured onto the surface of the
application electrode. Unbound substances are then removed with ProCell II M.
Application of a voltage to the electrode then induces chemiluminescent
Intended use emission which is measured by a photomultiplier.
Immunoassay for the in vitro qualitative determination of HIV‑1 p24 antigen ▪ Results are determined automatically by the software by comparing the
and antibodies to HIV‑1, including group O, and HIV‑2 in human serum and electrochemiluminescence signal obtained from the sample with the
plasma. The subresults (HIV Ag and anti‑HIV) are intended as an aid in the cutoff value obtained by HIV Ag embedded and anti‑HIV embedded
selection of the confirmation algorithm for reactive samples. calibration. The Elecsys HIV Duo result is calculated automatically
The electrochemiluminescence immunoassay “ECLIA” is intended for use based on signal to cutoff ratios (cutoff index, COI) from HIV Ag and
on the cobas e 801 immunoassay analyzer. anti‑HIV.
a) Tris(2,2'-bipyridyl)ruthenium(II)-complex (Ru(bpy) )
Regulatory approval
This assay has been CE marked according to Directive 98/79/EC. Test Reagents - working solutions
performance has been established and certified by a Notified Body The cobas e pack HIV Ag (M, R1, R2) is labeled as HIVAG.
according to the Common Technical Specifications (CTS) for diagnostic use The cobas e pack Anti‑HIV (M, R1, R2) is labeled as AHIV.
and for screening of blood donations and, according to Paul-Ehrlich-Institut
(PEI) recommendation,1 for use of cadaveric blood specimens (specimens HIVAG
collected post-mortem, non-heart-beating).
M Streptavidin-coated microparticles, 1 bottle, 14.1 mL:
Summary Streptavidin-coated microparticles 0.72 mg/mL; preservative.
The human immunodeficiency virus (HIV), the causative agent of Acquired
Immunodeficiency Syndrome (AIDS), belongs to the family of retroviruses. R1 Anti‑HIV p24-Ab~biotin, 1 bottle, 14.8 mL:
HIV can be transmitted through sexual contact, contaminated blood and Biotinylated monoclonal anti‑HIV p24 antibodies (mouse)
blood products or from an HIV-infected mother to her child before, during approximately 0.75 mg/L; MESb) buffer 50 mmol/L, pH 6.5;
and after birth. preservative.
Two types of HIV, called HIV‑1 and HIV‑2, have been identified to date.2,3,4,5
HIV‑1 can be divided into 4 distantly related groups: group M (for main), R2 Anti‑HIV p24-Ab~Ru(bpy) , 1 bottle, 14.8 mL:
group N (for non‑M, non‑O), group O (for outlier) and group P.6,7,8 Based on Monoclonal anti‑p24 antibodies (mouse) labeled with ruthenium
their genetic relationship, 9 different subtypes (A to D, F to H, J, K) as well complex approximately 0.75 mg/L; MES buffer 50 mmol/L, pH 6.5;
as several circulating recombinant forms (CRFs) have been identified within
HIV‑1 group M.9 The large majority of HIV‑1 infections are caused by preservative.
viruses belonging to group M, while geographical distribution of subtypes b) MES = 2-morpholino-ethane sulfonic acid
and CRFs within this group varies strongly.10 Due to differences in the
sequence of immunodominant epitopes, especially in the envelope proteins HIVDUO Cal1 Negative calibrator (lyophilized), 1 bottle for 1.0 mL:
of HIV‑1 group M, HIV‑1 group O and HIV‑2, specific antigens are Human serum, non-reactive for anti‑HIV‑1 and anti‑HIV‑2.
necessary to avoid failure in the detection of an HIV infection by
immunoassays.11,12 HIVDUO Cal2 Positive calibrator (lyophilized), 1 bottle for 1.0 mL:
HIV p24 antigen (E. coli, rDNA) in human serum, non-
HIV p24 antigen in blood specimen of recently infected patients can be
detected as early as 2‑3 weeks after infection.13,14 Anti‑HIV antibodies are reactive for anti‑HIV‑1 and anti‑HIV‑2.
detectable in serum from around 4 weeks post infection.13,15 The combined
detection of HIV p24 antigen and anti‑HIV antibodies in 4th generation HIV AHIV
screening assays leads to improved sensitivity and therefore a shorter M Streptavidin-coated microparticles, 1 bottle, 14.1 mL:
diagnostic window compared to traditional anti‑HIV assays.16,17
Streptavidin-coated microparticles 0.72 mg/mL; preservative.
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 R1 HIV‑1/2‑specific recombinant antigens (E. coli)~biotin,
two separate determinations. On the basis of these determinations, the HIV‑1/2‑specific synthetic peptides~biotin, 1 bottle, 14.8 mL:
Elecsys HIV Duo main result is subsequently calculated automatically by Biotinylated HIV‑1/2‑specific recombinant antigens (E. coli) and
the analyzer. The subresults HIV Ag and anti‑HIV can be used as an aid in biotinylated HIV‑1/2 specific synthetic peptides approximately
the selection of the confirmation algorithm for reactive samples. The
Elecsys HIV Duo assay uses monoclonal antibodies to detect the HIV Ag 0.63 mg/L; TESc) buffer 40 mmol/L, pH 7.3; preservative.
and recombinant antigens derived from the Env- and Pol-region of HIV‑1 R2 HIV‑1/2‑specific recombinant antigens (E. coli)~Ru(bpy) ,
(including group O) and HIV‑2 to detect anti‑HIV antibodies. Repeatedly
reactive samples must be confirmed according to recommended HIV‑1/2‑specific synthetic peptides~Ru(bpy) , 1 bottle, 14.8 mL:
confirmatory algorithms. HIV‑1/2‑specific recombinant antigens (E. coli) and HIV‑1/2‑specific
synthetic peptides labeled with ruthenium complex approximately
Test principle
1.22 mg/L; TES buffer 40 mmol/L, pH 7.3; preservative.
Sandwich principle. Total duration of assay: 18 minutes.
c) TES = 2-[[1,3-dihydroxy-2-(hydroxymethyl)propane-2-yl]amino]ethanesulfonic acid

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HIVDUO Cal3 Negative calibrator (lyophilized), 1 bottle for 1.0 mL: Unless the entire volume is necessary for calibration on the analyzer,
Human serum, non-reactive for anti‑HIV‑1 and anti‑HIV‑2. transfer aliquots of the freshly reconstituted calibrators into empty snap‑cap
bottles (CalSet Vials). Attach the supplied labels to these additional bottles.
HIVDUO Cal4 Positive calibrator (lyophilized), 1 bottle for 1.0 mL: Store the aliquots at 2‑8 °C or ‑20 °C for later use.
Anti‑HIV‑1 positive human serum (inactivated) in human Perform only one calibration procedure per aliquot.
serum negative for anti‑HIV‑1 and anti‑HIV‑2.
All information required for correct operation is available via the cobas link.
Precautions and warnings Storage and stability
For in vitro diagnostic use. Store at 2‑8 °C.
Exercise the normal precautions required for handling all laboratory
reagents. Do not freeze.
Disposal of all waste material should be in accordance with local guidelines. Store the cobas e pack upright in order to ensure complete availability of
Safety data sheet available for professional user on request. the microparticles during automatic mixing prior to use.
This kit contains components classified as follows in accordance with the
Regulation (EC) No. 1272/2008: 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:

Warning lyophilized up to the stated expiration date
reconstituted at 2‑8 °C 72 hours
H317 May cause an allergic skin reaction.
reconstituted at ‑20 °C 16 weeks (1 freeze/thaw cycle
H412 Harmful to aquatic life with long lasting effects. possible)
Prevention: on the cobas e 801 analyzer at use only once
20‑25 °C
P261 Avoid breathing dust/fume/gas/mist/vapours/spray.
Store calibrators upright in order to prevent the calibrator solution from
P273 Avoid release to the environment. adhering to the snap‑cap.
Specimen collection and preparation
P280 Wear protective gloves.
Specimen collected from living patients, blood donors, or individual organ,
Response: tissue or cell donors may be used, including donor samples obtained while
the donor’s heart is still beating.
P333 + P313 If skin irritation or rash occurs: Get medical Performance for the use of cadaveric blood specimens (specimens
advice/attention. collected post-mortem, non-heart-beating) was established according to
Paul-Ehrlich-Institut recommendation1 with samples obtained within
P362 + P364 Take off contaminated clothing and wash it before reuse. 24 hours after death.20 Qualitative differences of neat (non-reactive) or
spiked (reactive) specimens from cadaveric compared to living donors were
Disposal: not observed.
P501 Dispose of contents/container to an approved waste Criterion: Mean value of cadaveric specimens compared to specimens from
disposal plant. living donors within a recovery of 75‑125 %.
Only the specimens listed below were tested and found acceptable.
Product safety labeling follows EU GHS guidance.
Serum collected using standard sampling tubes or tubes containing
Contact phone: all countries: +49-621-7590 separating gel.
All human material should be considered potentially infectious. Li‑heparin, Na‑heparin, K2‑EDTA, K3‑EDTA, ACD, CPD, CP2D, CPDA and
The negative calibrators (HIVDUO Cal1 and HIVDUO Cal3) as well as the Na‑citrate plasma.
HIV Ag positive calibrator (HIVDUO Cal2) have been prepared exclusively Li‑heparin, K2‑EDTA and K3‑EDTA plasma tubes containing separating gel
from the blood of donors tested individually and shown to be free from can be used.
HBsAg and antibodies to HCV and HIV.
Criterion: Correct assignment of negative and positive samples within a
The testing methods used assays approved by the FDA or cleared in recovery of ± 0.2 COI for negative and 80‑120 % for positive samples.
compliance with the European Directive 98/79/EC, Annex II, List A.
Stability:
The serum containing anti‑HIV‑1 (HIVDUO Cal4) was inactivated using For living patients and donor specimens obtained while the donor’s heart is
β‑propiolactone and UV‑radiation. still beating: Stable for 7 days at 20‑25 °C, 4 weeks at 2‑8 °C, 3 months at
However, as no inactivation or testing method can rule out the potential risk ‑20 °C (± 5 °C). The samples may be frozen 5 times.
of infection with absolute certainty, the material should be handled with the For cadaveric specimens: Stable for 3 days at 20‑25 °C, 7 days at 2‑8 °C.
same level of care as a patient specimen. In the event of exposure, the The samples may be frozen 3 times.
directives of the responsible health authorities should be followed.18,19 Sampling devices containing liquid anticoagulants have a dilution effect
Avoid foam formation in all reagents and sample types (specimens, resulting in lower COI values for individual patient specimens. In order to
calibrators and controls). minimize dilution effects it is essential that respective sampling devices are
filled completely according to manufacturer’s instructions.
Reagent handling
The reagents (M, R1, R2) in the kit are ready-for-use and are supplied in The sample types listed were tested with a selection of sample collection
cobas e packs. 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
Calibrators systems from various manufacturers may contain differing materials which
Carefully dissolve the contents of one bottle by adding exactly 1.0 mL of could affect the test results in some cases. When processing samples in
distilled or deionized water and allow to stand closed for 15 minutes to primary tubes (sample collection systems), follow the instructions of the
reconstitute. Mix carefully, avoiding foam formation. tube manufacturer.
Transfer the reconstituted calibrators into the supplied empty labeled Centrifuge samples containing precipitates and thawed samples before
snap‑cap bottles. performing the assay.

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Do not use heat‑inactivated samples. Renewed calibration is recommended as follows:
Do not use samples and controls stabilized with azide. ▪ after 12 weeks when using the same reagent lot
Ensure the samples and calibrators are at 20‑25 °C prior to measurement. ▪ after 28 days when using the same cobas e pack on the analyzer
Due to possible evaporation effects, samples and calibrators on the ▪ as required: e.g. quality control findings outside the defined limits
analyzers should be analyzed/measured within 2 hours.
Range for the electrochemiluminescence signals (counts) for the
The performance of the Elecsys HIV Duo assay has not been established calibrators:
with body fluids other than serum and plasma. HIVAG negative calibrator (HIVDUO Cal1): 450‑1800
Materials provided HIVAG positive calibrator (HIVDUO Cal2): 10000‑40000
See “Reagents – working solutions” section for reagents. AHIV negative calibrator (HIVDUO Cal3): 450‑1800
AHIV positive calibrator (HIVDUO Cal4): 10000‑40000
▪ 4 bottle labels
Quality control
▪ 4 empty labeled snap-cap bottles For quality control, use PreciControl HIV Gen II.
Materials required (but not provided) In addition, PreciControl HIV; HIV‑2+GrpO can be used (optional). Note that
all HIV results are sufficiently controlled if only PreciControl HIV Gen II is
▪  06924107190, PreciControl HIV Gen II, for 6 x 2.0 mL used.
▪  06924115190, PreciControl HIV; HIV‑2+GrpO, for 4 x 2.0 mL Controls for the various concentration ranges should be run individually at
(optional use) least once every 24 hours when the test is in use, once per cobas e pack,
▪  11776576322, CalSet Vials, 2 x 56 empty snap-cap bottles and following each calibration.
▪ General laboratory equipment The control intervals and limits should be adapted to each laboratory’s
individual requirements. Values obtained should fall within the defined
▪ cobas e 801 analyzer limits. Each laboratory should establish corrective measures to be taken if
▪ Distilled or deionized water values fall outside the defined limits.
Additional materials for the cobas e 801 analyzer: If necessary, repeat the measurement of the samples concerned.
▪  06908799190, ProCell II M, 2 x 2 L system solution Follow the applicable government regulations and local guidelines for
quality control.
▪  04880293190, CleanCell M, 2 x 2 L measuring cell cleaning
solution Calculation
▪  07485409001, Reservoir Cup, 8 cups to supply ProCell II M and The analyzer automatically calculates the cutoff based on the measurement
CleanCell M of HIVDUO Cal1 and HIVDUO Cal2, HIVDUO Cal3 and HIVDUO Cal4.
▪  06908853190, PreClean II M, 2 x 2 L wash solution The result of a sample is given either as reactive or non-reactive as well as
in the form of a cutoff index (signal sample/cutoff).
▪  05694302001, Assay Tip/Assay Cup tray, 6 magazines The following formula is used to calculate the main Elecsys HIV Duo result
x 6 magazine stacks x 105 assay tips and 105 assay cups, 3 wasteliners based on the HIVAG and AHIV subresults:
▪  07485425001, Liquid Flow Cleaning Cup, 2 adaptor cups to supply
ISE Cleaning Solution/Elecsys SysClean for Liquid Flow Cleaning
Detection Unit HIVDUO (COI) = (HIVAG [COI])² + (AHIV [COI])²
▪  07485433001, PreWash Liquid Flow Cleaning Cup, 1 adaptor cup
to supply ISE Cleaning Solution/Elecsys SysClean for Liquid Flow Interpretation of the results
Cleaning PreWash Unit
Main result HIVDUO
▪  11298500316, ISE Cleaning Solution/Elecsys SysClean,
5 x 100 mL system cleaning solution Numeric result Result message Interpretation/
Assay further steps
For optimum performance of the assay follow the directions given in this COI < 1.00 Non-reactive Negative for HIV‑1 Ag and
document for the analyzer concerned. Refer to the appropriate operator’s negative for anti‑HIV‑1/2
manual for analyzer‑specific assay instructions. antibodies.
Resuspension of the microparticles takes place automatically prior to use. No further testing needed.
Place the cooled (stored at 2‑8 °C) cobas e pack on the reagent manager.
Avoid foam formation. The system automatically regulates the temperature COI ≥ 1.00 Reactive Reactive in the
of the reagents and the opening/closing of the cobas e pack. Elecsys HIV Duo assay. All
Calibrators: initially reactive samples
should be redetermined in
Place the reconstituted calibrators in the sample zone.
duplicate with the
Perform only one calibration procedure per aliquot.
Elecsys HIV Duo assay.
Calibration Redetermination of samples
Traceability: with an initial COI ≥ 1.00
HIVAG: can be performed
This method has been standardized against the WHO International automatically (see section
Standard HIV‑1‑p24 Antigen, NIBSC (National Institute for Biological cobas e flows).
Standards and Control) code 90/636.
AHIV: Main result HIVDUOR
No internationally accepted standard for anti‑HIV‑1 and anti‑HIV‑2 exists.
Calibration frequency: Calibration must be performed once per reagent lot Numeric result Result message Interpretation/
using HIVDUO Cal1, HIVDUO Cal2, HIVDUO Cal3, HIVDUO Cal4 and further steps
fresh reagent (i.e. not more than 24 hours since the cobas e pack was Both of the duplicate Non-reactive Negative for HIV‑1 Ag and
registered on the analyzer). retests have a COI negative for anti‑HIV‑1/2
Calibration interval may be extended based on acceptable verification of < 1.00 antibodies.
calibration by the laboratory.
No further testing needed.

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Numeric result Result message Interpretation/ Occurrence of high-dose hook effect cannot be completely excluded.
further steps Pharmaceutical substances
One or both of the Repeatedly reactive Repeatedly reactive In vitro tests were performed on 16 commonly used pharmaceuticals. No
interference with the assay was found.
duplicate retests samples must be confirmed
have a COI ≥ 1.00 according to recommended In rare cases, interference due to extremely high titers of antibodies to
analyte‑specific antibodies, streptavidin or ruthenium can occur. These
confirmatory algorithms. effects are minimized by suitable test design.
Confirmatory tests include For diagnostic purposes, the results should always be assessed in
Western Blot and HIV RNA conjunction with the patient’s medical history, clinical examination and other
tests. For the right choice of findings.
method the module‑specific A negative test result does not completely rule out the possibility of an
subresult for HIVAG and infection with HIV. Serum or plasma samples from the very early (pre-
AHIV can be used. seroconversion) phase or the late phase of HIV infection can occasionally
yield negative findings. Yet unknown HIV variants can also lead to a
Subresult HIVAG negative HIV finding. The presence of antibodies to HIV is not a diagnosis
of AIDS.
Numeric result Result message Interpretation/
Limits and ranges
further steps
Antigen detection (HIVAG/HIVDUO)
COI < 1.00 Non-reactive Negative for HIV‑1 p24 ≤ 1.0 IU/mL
antigen. Antigen sensitivity was determined based on serial dilutions of the WHO
International Standard HIV‑1 p24 antigen, NIBSC (National Institute for
COI ≥ 1.00 Reactive Reactive in the HIV Ag Biological Standards and Control) code 90/636, in human HIV negative
module. serum.
Antibody detection (AHIV/HIVDUO)
Subresult AHIV No internationally accepted standard for HIV‑specific antibody detection
Numeric result Result message Interpretation/ exists.
further steps Specific performance data
COI < 1.00 Non-reactive Negative for anti‑HIV‑1/2 Representative performance data on the analyzer is given below. Results
obtained in individual laboratories may differ.
antibodies.
Precision
COI ≥ 1.00 Reactive Reactive in the anti‑HIV
Precision was determined using Elecsys reagents, samples and controls in
module. a protocol (EP05‑A3) of the CLSI (Clinical and Laboratory Standards
Please note: In case the HIVAG and AHIV results are both in the range of Institute): 2 runs per day in duplicate each for 21 days (n = 84). The
COI 0.708‑0.999, the combined Elecsys HIV Duo main result will have a following results were obtained:
COI ≥ 1.00 and will be reported as reactive.
cobas e 801 analyzer
cobas e flows
cobas e flows are procedures programmed into the system to enable a fully Repeatability Intermediate
automated sequence of measurements and the calculation of assay precision
combinations to perform decision algorithms.
The HIVDUO cobas e flow is required to enable simultaneous separate Sample Mean SD CV SD CV
measurement of HIVAG and AHIV with subsequent calculation of the main COI COI % COI %
result. HSPd), negative 0.160 0.007 4.5 0.009 5.9
A second HIV cobas e flow is available to perform a repetition of
measurements in duplicate automatically for samples with an initial cutoff HSP, positive for 2.12 0.045 2.1 0.048 2.2
index ≥ 1.00 (short name HIVDUOR). Both subresults and the overall result HIV‑1 p24 antigen
message will be reported.
HSP, positive for 2.12 0.033 1.6 0.043 2.0
Limitations - interference anti‑HIV‑1
The effect of the following endogenous substances and pharmaceutical
compounds on assay performance was tested. Interferences were tested HSP, positive for 53.0 0.793 1.5 1.01 1.9
up to the listed concentrations and no impact on results was observed. anti‑HIV‑1
Endogenous substances HSP, positive for 1.97 0.024 1.2 0.029 1.5
anti‑HIV‑2
Compound Concentration tested
HSP, positive for 1.99 0.030 1.5 0.034 1.7
Bilirubin ≤ 1129 µmol/L or ≤ 66 mg/dL anti‑HIV GrpO
Hemoglobin ≤ 0.311 mmol/L or ≤ 500 mg/dL PCe) HIV1 0.200 0.008 4.1 0.010 5.1
Intralipid ≤ 2000 mg/dL PC HIV2 3.64 0.053 1.5 0.060 1.7
Biotin ≤ 196 nmol/L or ≤ 48 ng/mL PC HIV3 12.6 0.150 1.2 0.208 1.6
Rheumatoid factors ≤ 1200 IU/mL PC HIV4 4.51 0.081 1.8 0.092 2.0
Criterion: Correct assignment of negative and positive samples within a PC HIV5 5.10 0.090 1.8 0.101 2.0
recovery of ± 0.15 COI for negative samples and 80‑120 % for positive
samples. d) HSP = human specimen (serum/plasma)
Samples should not be taken from patients receiving therapy with high e) PC = PreciControl
biotin doses (i.e. > 5 mg/day) until at least 8 hours following the last biotin Analytical specificity
administration. 196 samples containing potentially interfering substances were tested with
No false negative result due to high‑dose hook effect was found with the the Elecsys HIV Duo assay comprising specimens:
Elecsys HIV Duo assay.

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▪ containing antibodies against HAV, HBV, HCV, HTLV, CMV, EBV, HSV, References
Rubella, Treponema pallidum 1 Proposal for the Validation of Anti-HIV-1/2 or HIV Ag/Ab Combination
▪ containing autoantibodies and elevated titers of rheumatoid factor Assays, anti-HCV-Assays, HBsAg and Anti-HBc assays for Use with
Cadaveric Samples; PEI 08/05/2014.
▪ positive for Candida, E. coli, Plasmodium falciparum/vivax,
Mycobacterium tuberculosis 2 Barré-Sinoussi F, Chermann JC, Rey F, et al. Isolation of a T-
lymphotrophic Retrovirus from a Patient at Risk for Acquired Immune
▪ after vaccination against HAV, HBV and influenza Deficiency Syndrome (AIDS). Science 1983;220:868-871.
▪ from patients with monoclonal gammopathy and multiple 3 Popovic M, Sarngadharan MG, Read E, et al. Detection, Isolation and
myeloma/lymphoma Continuous Production of Cytopathic Retroviruses (HTLV-III) from
N Elecsys HIV Duo WB** WB negative, Analytical specificity Patients with AIDS and Pre-AIDS. Science 1984;224:497-500.
assay, RR* HIV Ag negative (95 % lower confidence 4 Gallo RC, Salahuddin SZ, Popovic M, et al. Frequent Detection and
limit) Isolation of cytopathic Retroviruses (HTLV-III) from Patients with AIDS
and RISk for AIDS. Science 1984;224:500-503.
Specimens containing 196 0 0 0 100 %
potentially interfering (98.14 %)
5 Clavel F, Guétard D, Brun-Vézinet F, et al. Isolation of a New Human
Retrovirus from West Africa Patients with AIDS. Science
substances
1986;233:343-346.
* RR = repeatedly reactive 6 Guertler LG, Hauser PH, Eberle J, et al. A New Subtype of Human
** Western Blot (WB) confirmed positive/indeterminate Immunodeficiency Virus Type 1 (MVP-5180) from Cameroon. J Virol
Clinical sensitivity 1994;68(3):1581-1585.
Of 356 samples from early HIV seroconversion phase (according to CTS 7 Simon F, Mauclère P, Roques P, et al. Identification of a new human
definition), 350 were found positive with the Elecsys HIV Duo assay. Of immunodeficiency virus type 1 distinct from group M and group O.
1699 samples from HIV infected patients in different stages of the disease Nature Medicine 1998;4(9):1032-1037.
and infected with HIV‑1 group M, O and HIV‑2, 1699 were found to be 8 Plantier JC, Leoz M, Dickerson JE, et al. A new human
repeatedly reactive with the Elecsys HIV Duo assay. The sensitivity of the immunodeficiency virus derived from gorillas. Nature Medicine
Elecsys HIV Duo assay in this study was 100 %. The 95 % lower 2009;15(8):871-872.
confidence limit was 99.78 %.
9 Robertson DL, Anderson JP, Bradac JA, et al. HIV-1 nomenclature
Group N Reactive Proposal. Science 2000;288(5463):55-56.
Infection with HIV‑1 group M 1395 1395 10 Taylor BS, Hammer SM. The challenge of HIV-1 subtype diversity. N
Engl J Med 2008;358:1590-1602.
(subtypes A‑K)
11 Guertler LG. Difficulties and strategies of HIV diagnosis. Lancet
Infection with HIV‑1 group O 52 52 1996;348:176-179.
Infection with HIV‑2 202 202 12 Verdier M, Denis F, Leonard G, et al. Comparison of 10 Enzyme
Positive for HIV Ag 50 50 Immunoassays for Detection of Antibody to Human Immunodeficiency
Virus Type 2 in West African Sera. J Clin Microbiol 1988;26:1000-1004.
55 different virus lysates of cell culture supernatants including different 13 Fiebig EW, Wright DJ, Rawal BD, et al. Dynamics of HIV viremia and
HIV‑1 group M subtypes (A‑H), HIV‑1 group O, and HIV‑2 were tested and antibody seroconversion in plasma donors: implications for diagnosis
found reactive in the Elecsys HIV Duo assay. and staging of primary HIV infection. AIDS 2003;17(13):1871-1879.
Clinical specificity 14 Busch MP, Lee LL, Satten GA, et al. Time course of detection of viral
In a group of 13330 randomly selected blood donors from Europe and Asia and serologic markers preceding human immunodeficiency virus type 1
the specificity of the Elecsys HIV Duo assay was found 99.87 % (IR and seroconversion: implications for screening of blood and tissue donors.
RR). The 95 % lower confidence limit was 99.80 %. Transfusion 1995;35:91-97.
In a group of 2368 samples from unselected daily routine, dialysis patients 15 Busch MP, Satten GA. Time course of viremia and antibody
and pregnant women the specificity of the Elecsys HIV Duo assay was seroconversion following human immunodeficiency virus exposure. Am
found 99.92 % (IR and RR). The 95 % lower confidence limit was 99.70 %. J Med 1997;102(5B):117-124.
N Elecsys HIV Duo assay WB** Clinical specificity 16 Weber B, Fall EH, Berger A, et al. Reduction of Diagnostic Window by
IR* RR
(95 % lower confidence New Fourth-generation Human immunodeficiency Virus Screening
limit) Assays. Clin Microbiol 1998;36(8):2235-2239.
COI ≥ 1 COI ≥ 1
17 Guertler L, Mühlbacher A, Michl U, et al. Reduction of the diagnostic
Blood donors 13330 17 17 0 99.87 % window with a new combined p24 antigen and human
(99.80 %) immunodeficiency virus antibody screening assay. Journal of
Unselected samples 1000 0 0 0 100 %
Virological Methods 1998;75:27-38.
from daily routine (99.63 %) 18 Occupational Safety and Health Standards: Bloodborne pathogens.
(29 CFR Part 1910.1030). Fed. Register.
Dialysis patients 280 1 1 0/1 100 %
(98.69 %)
19 Directive 2000/54/EC of the European Parliament and Council of
18 September 2000 on the protection of workers from risks related to
Pregnant women 1090 3 3 1/0 99.82 % exposure to biological agents at work.
(99.34 %) 20 Commission Directive 2006/17/EC of 8 February 2006 implementing
* IR = initially reactive Directive 2004/23/EC of the European Parliament and of the Council as
** Western Blot confirmed positive/indeterminate. Samples with indeterminate WB were excluded from the calcu­ regards certain technical requirements for the donation, procurement
lation.
and testing of human tissues and cells.
For further information, please refer to the appropriate operator’s manual for
Seroconversion panels the analyzer concerned, the respective application sheets, the product
Seroconversion sensitivity of the Elecsys HIV Duo assay has been shown information and the Method Sheets of all necessary components (if
by testing 139 commercial seroconversion panels in comparison to other available in your country).
registered HIV combination assays or anti‑HIV assays and/or HIV Ag A point (period/stop) is always used in this Method Sheet as the decimal
assays. separator to mark the border between the integral and the fractional parts of
a decimal numeral. Separators for thousands are not used.

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Elecsys HIV Duo

Symbols
Roche Diagnostics uses the following symbols and signs in addition to
those listed in the ISO 15223‑1 standard (for USA: see dialog.roche.com for
definition of symbols used):
Contents of kit
Analyzers/Instruments on which reagents can be used
Reagent
Calibrator
Volume after reconstitution or mixing
GTIN Global Trade Item Number

COBAS, COBAS E, ELECSYS and PRECICONTROL are trademarks of Roche. INTRALIPID is a trademark of
Fresenius Kabi AB.
All other product names and trademarks are the property of their respective owners.
Additions, deletions or changes are indicated by a change bar in the margin.
© 2020, Roche Diagnostics

Roche Diagnostics GmbH, Sandhofer Strasse 116, D-68305 Mannheim

www.roche.com

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