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VIDAS® HIV DUO Ultra (HIV5)

VIDAS HIV DUO Ultra is an automated HIV infection screening test for use on the VIDAS family instruments, for the
combined detection of anti-HIV-1 (groups M and O) and anti-HIV-2 total immunoglobulins and HIV-1 p24 antigen in
human serum or plasma (lithium heparin or EDTA) using the ELFA technique (Enzyme Linked Fluorescent Assay).

SUMMARY AND EXPLANATION The upper part of the SPR is coated with monoclonal anti-
Human immunodeficiency viruses (HIV) are RNA p24 antibodies for the detection of p24 antigen. The lower
retroviruses transmitted via sexual contact, parenteral and part of the SPR enables the detection of anti-HIV-1 and
perinatal pathways or the placenta. HIV-1 and HIV-2 were anti-HIV-2 antibodies: it is coated with an HIV-1 gp160
respectively isolated in 1983 and 1985 in patients infected protein, and HIV-1 group O and HIV-2 specific synthetic
by AIDS (Acquired Immunodeficiency Syndrome). Since peptides.
then numerous genetic variants have been characterized. During preliminary incubation, the sample, the biotinylated
These mutations seemed to be without consequence for anti-p24 antibody (rabbit) in the strip are cycled in and out
serological diagnosis until HIV-1 variants of group O of the SPR. Lysis of the virus occurs during incubation
(Outlier) were isolated, since they have only 50% and the released p24 antigen binds to the monoclonal
homology at the env gene level with those of group M anti-p24 antibody coated on the SPR and is recognized by
(Major) (1, 2, 3, 4, 5). the biotinylated anti-p24 antibody. At the same time, the
During 2007, 2.5 million individuals were newly infected anti-HIV-1 and/or anti-HIV-2 antibodies bind to the gp160
by HIV. According to estimates, 33.2 million [30.6 – 36.1 and/or the peptides in the lower part of the SPR.
million] people were living with HIV in 2007 (6). Two washing steps remove unbound components.
Current diagnosis of HIV infection relies on the detection A second incubation with the biotinylated antigen in the
of anti-HIV serum antibodies using an ELISA method. strip (the same used in the solid phase) is only performed
However, there is a mean period of 3 weeks between in the lower part of the SPR. The biotinylated antigen
contamination and the appearance of the first antibodies binds to any anti-HIV antibody coated in the lower part of
(7). During this period p24 antigen is present in most the SPR.
people infected by HIV-1 (8). Thus simultaneous detection Any excess reagent is eliminated by washing.
of p24 antigenemia, anti-HIV-1 and anti-HIV-2 antibodies
enables the time lapse between contamination and A third incubation is performed with alkaline phosphatase-
diagnosis of the infection to be decreased (9, 10). VIDAS labeled streptavidin. During this step, the streptavidin
HIV DUO Ultra is an automated test based on the binds to the biotinylated anti-p24 antibody, if it is present
combined detection of HIV-1 p24 antigen and anti-HIV-1 in the upper part of the SPR, and to the biotinylated
and anti-HIV-2 total immunogloblins, enabling a reduction antigen, if it is present in the lower part of the SPR.
of the seroconversion window. Any excess reagent is eliminated by washing.
Note: The use of VIDAS HIV DUO Ultra does not rule out The substrate (4-Methyl-umbelliferyl phosphate) is firstly
the obligation of using a second technique in countries incubated in the lower part of the SPR and the
where legislation requires the use of two different fluorescence is measured at 450 nm. The intensity of the
screening tests. fluorescence is proportional to the presence of anti-HIV
antibody in the sample.
The substrate is then incubated in the complete SPR and
PRINCIPLE
a second fluorescence measurement is performed. The
The principle of the test combines 2 enzyme instrument calculates the intensity of the fluorescence in
immunoassay reactions with two final fluorescent the upper part of the SPR. This intensity is proportional to
detections (ELFA). the concentration of HIV-1 p24 antigen in the sample.
The Solid Phase Receptacle (SPR), serves as the solid At the end of the assay, results are automatically
phase as well as the pipetting device for the assay. calculated by the instrument in relation to the standard,
Reagents for the assay are ready-to-use and are pre- and then printed out.
dispensed in the sealed reagent strips.
All of the assay steps are performed automatically by the
instrument. The reaction medium is cycled in and out of
the SPR several times.

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VIDAS HIV DUO Ultra (HIV5) 09691 I - en - 2015/06

CONTENT OF THE KIT (60 TESTS) – RECONSTITUTION OF REAGENTS:

60 HIV5 strips STR Ready-to-use.
60 HIV5 SPRs SPR Ready-to-use.
(2 x 30) Interior of SPRs coated with gp160 (HIV-1) protein, HIV-1 group O and HIV-2
specific synthetic peptides, and monoclonal anti-p24 antibodies.
HIV5 positive antibody C1 Reconstitute with 2 ml of distilled water. Leave for 5 to 10 minutes and then mix.
control After reconstitution, stable for 2 months at 2-8°C.
(1 x 2.0 ml) Human serum* with anti-HIV-1 antibody + TRIS (0.1 mol/l, pH 7.4) + protein and
(lyophilized) chemical stabilizers + preservatives.
MLE data indicate the confidence interval for the antibody result (Control C1 (+) Test
Value Range).
HIV5 negative control C2 Ready-to-use.
(1 x 1.3 ml) (liquid) Human serum** + TRIS (0.1 mol/l, pH 7.4) + protein and chemical stabilizers +
preservatives.
HIV5 positive antigen C3 Reconstitute with 2 ml of distilled water. Leave for 5 to 10 minutes and then mix.
control After reconstitution, stable for 2 months at 2-8°C.
(1 x 2.0 ml) Human serum** with inactivated HIV-1 viral lysate + TRIS (0.1 mol/l, pH 7.4) +
(lyophilized) protein and chemical stabilizers + preservatives.
MLE data indicate the confidence interval for the antigen result (Control C3 (+) Test
Value Range).
HIV5 antibody standard S1 Reconstitute with 2 ml of distilled water. Leave for 5 to 10 minutes and then mix.
(1 x 2.0 ml) After reconstitution, stable for 2 months at 2-8°C.
(lyophilized) Human serum* with anti-HIV-1 antibody + TRIS (0.1 mol/l, pH 7.4) + protein and
chemical stabilizers + preservatives.
MLE data indicate the confidence interval in "Relative Fluorescence Value (RFV)"
("Standard (S1) RFV Range").
HIV5 p24 antigen S2 Reconstitute with 2 ml of distilled water. Leave for 5 to 10 minutes and then mix.
standard After reconstitution, stable for 2 months at 2-8°C.
1 x 2.0 ml (lyophilized) Human serum** + TRIS (0.1 mol/l, pH 7.4) + protein and chemical stabilizers +
inactivated HIV-1 viral lysate + preservatives.
MLE data indicate the confidence interval in "Relative Fluorescence Value (RFV)"
("Standard (S2) RFV Range").
Specifications for the factory master data required to calibrate the test:
• MLE data (Master Lot Entry) provided in the kit,
or
• MLE bar code printed on the box label.
Clip seal
1 Package insert provided in the kit or downloadable from www.biomerieux.com/techlib
* This product has been tested and shown to be negative for HBs surface antigen and antibodies to HCV. This product has been heat
inactivated (30 minutes at 56°C). However, since no existing test method can totally guarantee their absence, this product must be
treated as potentially infectious. Therefore, usual safety procedures should be observed when handling.
** This product has been tested and shown to be negative for HBs surface antigen, and antibodies to HIV1, HIV2 and HCV. However,
since no existing test method can totally guarantee their absence, this product must be treated as potentially infectious. Therefore,
usual safety procedures should be observed when handling.

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The SPR The strip

The interior of the SPR is coated during production with a The strip consists of 10 wells covered with a labeled, foil
gp160 protein and HIV-1 group O and HIV-2 specific seal. The label comprises a bar code which mainly
synthetic peptides in the lower part, and monoclonal anti- indicates the assay code, kit lot number and expiration
p24 antibodies in the upper part. The antigens enable the date. The foil of the first well is perforated to facilitate the
capture of anti-HIV-1 and/or anti-HIV-2 antibodies, and introduction of the sample. The last well of each strip is a
the monoclonal antibodies enable the capture of HIV-1 cuvette in which the fluorometric reading is performed.
p24 antigen. The wells in the center section of the strip contain the
Each SPR is identified by the HIV-5 code. Only remove various reagents required for the assay.
the required number of SPRs from the pouch and
carefully reseal the pouch after opening using the clip
seal provided with the kit.
Description of the VIDAS HIV DUO Ultra strip:
Wells Reagents
1 Sample well.
2 HEPES buffer + biotin-labeled anti-p24 antibody (rabbit) + triton X100 + goat serum
+ protein and chemical stabilizers + 0.2 g/l gentamicin sulfate + 0.9 g/l sodium azide
(300 µl).
3-5-6-8-9 Wash buffer: TRIS + protein and chemical stabilizers + 0.9 g/l sodium azide (600
µl).
4 HEPES buffer + gp160 protein and biotin-labeled synthetic peptides + skimmed milk
+ protein and chemical stabilizers + 0.2 g/l gentamicin sulfate + 0.9 g/l sodium azide
(300 µl).
7 Tracer: alkaline phosphatase-labeled streptavidin + TRIS + skimmed milk + bovine
albumin + triton X100 + protein and chemical stabilizers + 0.2 g/l gentamicin sulfate
+ 0.9 g/l sodium azide (400 µl).
10 Reading cuvette with substrate: 4-Methyl-umbelliferyl phosphate (0.6 mmol/l) +
diethanolamine (DEA*) (0.62 mol/l or 6.6 %, pH 9.2) + 1 g/l sodium
azide (300 µl).

* Signal Word: DANGER

Hazard statement
H318 : Causes serious eye damage.
Precautionary statement
P280 :Wear protective gloves/protective clothing/eye protection/face protection.
P305 + P351 + P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present
and easy to do. Continue rinsing.
For further information, refer to the Material Safety Data Sheet.

MATERIALS AND DISPOSABLES REQUIRED BUT • This kit contains products of animal origin. Certified
NOT PROVIDED knowledge of the origin and/or sanitary state of the
- Pipette with disposable tip to dispense 2 ml and 200 µl. animals does not totally guarantee the absence of
- Powderless, disposable gloves. transmissible pathogenic agents. It is therefore
- For other specific materials and disposables, please recommended that these products be treated as
refer to the Instrument User’s Manual. potentially infectious and handled observing the usual
- VIDAS family instrument. safety precautions (do not ingest or inhale).
• Do not use the SPRs if the pouch is pierced.
WARNINGS AND PRECAUTIONS • Do not use visibly deteriorated STRs (damaged foil or
plastic).
• For in vitro diagnostic use only. • Do not use reagents after the expiration date indicated
• For professional use only. on the box label.
• This kit contains products of human origin. No • Do not mix reagents (or disposables) from different lots.
known analysis method can totally guarantee the • Use powderless gloves, as powder has been reported
absence of transmissible pathogenic agents. It is to cause false results for certain enzyme immunoassay
therefore recommended that these products be tests.
treated as potentially infectious and handled
observing the usual safety precautions (see
Laboratory biosafety manual - WHO - Geneva -
Latest edition).

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• Kit reagents contain sodium azide which can react with INSTRUCTIONS FOR USE
lead or copper plumbing to form explosive metal azides. For complete instructions, see the User’s Manual.
If any liquid containing sodium azide is disposed of in
the plumbing system, drains should be flushed with Reading Master lot data
water to avoid build-up. Before each new lot of reagents is used, enter the
• The substrate in well 10 contains an irritant agent (6.6% specifications (or factory master data) into the instrument
diethanolamine). Refer to the hazard statements "H" and using the master lot entry (MLE) data.
the precautionary statements "P" above. If this operation is not performed before initiating the
• Spills should be wiped up thoroughly after treatment tests, the instrument will not be able to print results.
with liquid detergent or a solution of household bleach
containing at least 0.5% sodium hypochlorite. See the Note: the master lot data need only be entered once
User’s Manual for cleaning spills on or in the instrument. for each lot.
Do not autoclave solutions containing bleach. It is possible to enter MLE data manually or
• The instrument should be regularly cleaned and automatically depending on the instrument (refer to the
decontaminated (see the User’s Manual). User’s Manual).
Calibration
STORAGE CONDITIONS Calibration, using the standards S1 and S2 provided in
• Store the VIDAS HIV DUO Ultra kit at 2-8°C. the kit, must be performed each time a new lot of reagents
• Do not freeze reagents. is opened, after the master lot data have been entered.
• Store all unused reagents at 2-8°C. Calibration should then be performed every 14 days. This
• After opening the kit, check that the SPR pouch is operation provides instrument-specific calibration curves
correctly sealed and undamaged. If not, do not use the and compensates for possible minor variations in assay
SPRs. signal throughout the shelf-life of the kit.
• To maintain stability of the remaining SPRs, The standards, identified by S1 and S2, must be tested in
carefully reseal the pouch after use with the duplicate (see User’s Manual). The standard value must
desiccant inside using the clip seal provided, and be within the set RFV "Relative Fluorescence Value"
return the complete kit to 2-8°C. range. If this is not the case, recalibrate.
• If stored according to the recommended conditions, all
Procedure
components are stable until the expiration date indicated
on the label. Refer to the kit composition table for 1. Only remove the required reagents from the
special storage conditions. refrigerator and allow them to come to room
temperature for at least 30 minutes.
SPECIMENS 2. Use one "HIV5" strip and one "HIV5" SPR for each
sample, control or standard to be tested. Make sure
Specimen type and collection the storage pouch has been carefully resealed
Human serum or plasma (collected in lithium heparin or with the clip seal after the required SPRs have
EDTA). been removed.
Do not use recalcified plasma. 3. The test is identified by the "HIV5" code on the
It is recommended that each laboratory checks the instrument.. The standards must be identified by "S1"
compatibility of collection tubes used. and “S2”, and tested in duplicate. If the positive
Do not inactivate specimens. controls are to be tested, they should be identified by
None of the following factors have been found to "C1" and “C3”. If the negative control needs to be
significantly influence this assay. tested, it should be identified by “C2”.
- hemolysis (after spiking samples with hemoglobin: 0 to
300 µmol/l (monomer)). 4. If necessary, clarify samples by centrifugation.
- lipemia (after spiking samples with lipids: 0 to 30 mg/ml 5. Mix the standards, controls and samples using a
equivalent in triglycerides) vortex-type mixer (for serum or plasma separated from
- bilirubinemia (after spiking samples with bilirubin: 0 to the pellet) in order to improve result reproducibility.
200 mg/l 6. For this test, the standard, control, and sample
However, it is recommended not to use samples that are test portion is precisely 200 µl. The test portion is
clearly hemolyzed, lipemic or icteric and, if possible, to pipetted into the sample well, which is used as the
collect a new sample. reaction cuvette for this test
Specimen stability 7. Insert the "HIV5" SPRs and "HIV5" strips into the
Samples can be stored at 2-8 °C in stoppered tubes for up instrument. Check to make sure the color labels with
to 2 days. If longer storage is required, freeze the sera or the assay code on the SPRs and the Reagent Strips
plasma at -25 ± 6°C. match.
Avoid successive freezing and thawing. 8. Initiate the assay as directed in the User’s Manual. All
A study performed on samples frozen for 2 months, the assay steps are performed automatically by the
showed that the quality of results is not instrument.
affected.instructions for use
9. Restopper the vials and return them to 2–8°C after
For complete instructions, see the User’s Manual.
pipetting.
10. The assay will be completed within approximately
2 hours. After the assay is completed, remove the
SPRs and strips from the instrument.
11. Dispose of the used SPRs and strips into an
appropriate recipient.

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RESULTS AND INTERPRETATION If these additional tests are negative, it is strongly

Once the assay is completed, results are analyzed recommended to test a second sample collected a few
automatically by the computer. Fluorescence is measured days later, particularly in the presence of clinical
twice in each Reagent Strip's reading cuvette for each symptoms and/or risk factors.
sample tested. - If the test value for antigen detection is > 0.25, the
The first reading is a background reading of the substrate additional technique should be based on p24 antigen
cuvette before the SPR is introduced into the substrate. detection and/or the determination of viral load.
The second reading is performed for the detection of anti- Note: country-specific requirements for HIV
HIV antibodies after the substrate has been incubated diagnostics must be taken into account if necessary.
with the enzyme in the lower part of the SPR. Interpretation of test results should be made taking into
The third reading is performed for the detection of HIV-1 consideration the patient history, and the results of any
p24 antigen after the substrate has been incubated with other tests performed.
the enzyme covering the interior of the SPR.
The RFVs appear on the result sheet. QUALITY CONTROL
The test values are calculated for each of the antibody A positive antibody control, a positive antigen control, and
(AB on the result sheet) and antigen (AG on the result a negative control are included in each VIDAS HIV DUO
sheet) results, by the VIDAS system as follows: Ultra kit. These controls must be performed immediately
after opening a new kit to ensure that reagent
Test value = patient RFV of the specific result/ specific performance has not been altered. Each calibration must
standard RFV also be checked using these controls. The instrument will
The interpreted result for each sample (HIV5 on the result only be able to check the control values if they are
sheet) is calculated according to the antigen and antibody identified by C1, C2 and C3.
test value as follows: Whatever the value of the antibody result for the C3
positive antigen control, only the Ag result validates this
Test value Interpreted result control.
< 0.25 (for antigen and antibody Negative Results cannot be validated if the control value deviates
detection) from the expected values.
> 0.25 (for antigen or antibody Positive Note
detection) It is the responsibility of the user to perform Quality
High RFVs obtained for antibody detection may mask the Control in accordance with any local applicable
antigen result, and vice versa. The test value is not regulations.
displayed for the masked result, and the message N.D.
"Not Determinable" appears instead. In this case, LIMITATIONS OF THE METHOD
interpretation is valid. VIDAS HIV DUO Ultra is an HIV infection screening test.
For some negative samples, the antibody test value may It should not be used as a specific test for the
be associated with an antigen test value that is ND “Not detection of HIV-1 p24 antigenemia. VIDAS HIV DUO
Determinable” due to an antigen result that cannot be Ultra must not be used as a supplementary test for
calculated by the VIDAS software but which is VIDAS HIV DUO Quick.
nonetheless below the threshold value. Refer to the - This test has been validated for use with serum or
negative test interpretation. plasma but not with other body fluids such as saliva,
If the message "Invalid" is generated for the sample, the CSF or urine.
result is invalid. In this case, the sample should be - Since the use of recalcified plasma may generate false
retested. positive results, this type of sample must not be used.
Samples with a negative test value are considered to be
negative, within the performance limitations of the - In exceptional cases where the p24 antigen
reagent. In cases of suspected primary infection, values ≅ concentration is very high, the antigen result may be
0.25 must be interpreted with caution. displayed as N.D (Not Determinable) and the signal for
Samples with a positive test value should be retested in the antibody result may be over-evaluated. The final
duplicate: interpretation of the test is positive.
- Non repeatable positive samples (two negative Do not use a mixture of samples.
reactions for three tests) are considered to be negative, Interference may be encountered with certain sera
within the performance limitations of the reagent. containing antibodies directed against reagent
- Repeatable positive samples (at least two positive components. For this reason, assay results should be
reactions for three tests) should be confirmed using interpreted taking into consideration the patient history,
additional techniques. and the results of any other tests performed.
If one of the two results is positive, this facilitates the
choice of an additional technique:
- If the test value for antibody detection is > 0.25, the
additional technique can be Western Blot and/or a
second screening test for detection of anti-HIV
antibodies.

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PERFORMANCE 5. Sensitivity on seroconversion panels

Studies performed using VIDAS HIV DUO ultra gave the During different studies, 45 seroconversion panels were
following results tested, demonstrating the early detection capabilities of
1. Specificity on a blood donor population: VIDAS HIV DUO Ultra.
The dilutions of the 3 HIV-1 samples and the 2 HIV-2
5008 blood donor samples from 3 blood banks were samples of the EFS 96 panel were found to be positive.
tested. The sensitivity of VIDAS HIV DUO Ultra, determined on
Final interpretation the Ag HIV SFTS panel (subtype B), was estimated at
11.5 pg/ml of HIV-1 antigen. The sensitivity of VIDAS HIV
VIDAS HIV DUO Ultra Positive Negative DUO Ultra, determined using the international standard
Positive 0 6 NIBSC 90/636 was estimated at 0.5 IU/ml of HIV-1
Negative 0 5002 antigen.
At least 40 early HIV seroconversion samples were
Specificity of the VIDAS HIV DUO Ultra reagent on this tested. The results are conform with the state of the art.
population: 99.88%
(95% confidence interval: 99.73% - 99.95%.) 6. Precision
2. Specificity on hospitalized patients: Intra-assay and inter-assay reproducibility, determined at
two different sites, were calculated according to the
No false positive results were found for the 200 samples recommendations of NCCLS document EP5-T2, volume
tested. 12-4.
Specificity of the VIDAS HIV DUO Ultra reagent on this
population: 100.00%. Site 1
(95% confidence interval: 98.04% - 100.00%) Mean Intra-assay Inter-assay
3. Specificity on high-risk behavior patients: Sample n index reproducibility reproducibility
No false positive results were found for the 100 samples % %
tested. Low
Specificity of the VIDAS HIV DUO Ultra reagent on this positive 40 3.19 2.28 2.54
population: 100.00%. antigen
(95% confidence interval: 96.38% - 100.00%)
Low
4. Diagnostic sensitivity: positive 40 4.54 4.13 5.71
antibody
A study was performed using 440 samples presumed to
be HIV-1 positive and 122 HIV-2 positive. All of the Site 2
samples were found to be positive.
Sensitivity of the VIDAS HIV DUO Ultra reagent on this Mean Intra-assay Inter-assay
population: 100.00% (95% confidence interval: 99.29% - Sample n index reproducibility reproducibility
100.00%). % %
In order to check the sensitivity of VIDAS HIV DUO Ultra Low
on non-B subtypes, 40 group M samples (4A, 14B, 3C, positive 40 3.08 2.95 4.92
3D, 3F, 3G, 3H, 3CRF01-AE and 4 CRF02-AG) and 10 antigen
group O samples were tested. All were found to be
Low
positive.
positive 40 4.18 6.97 8.33
31 fresh samples with a positive status (collection
antibody
< 24 hours) were tested and found to be positive with
VIDAS HIV DUO Ultra. 31 fresh samples with a negative Global analysis
status (collection < 24 hours) were tested and found to be
negative with VIDAS HIV DUO Ultra. Mean Inter-assay reproducibility
In order to check the sensitivity of VIDAS HIV DUO Ultra Sample n
index %
on p24 antigen, at least 50 culture supernatants including
Low
different HIV-1 and HIV-2 subtypes and at least 50 p24
positive 80 3.13 4.51
antigen-positive samples were tested. All were found to
antigen
be positive.
Low
positive 80 4.37 9.03
antibody
In this analysis, the reproducibility takes into account
within-run variability, and between-run and between-site
dispersion.

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7. Cross-reactivity 7. S.Kleinman, M.P.Busch, J.J.Korelitz et al. The

Incidence/Window Period Model and its Use to Assess the
134 HIV negative samples from patients whose Risk of Transfusion-Transmitted Human Immunodeficiency
physiological status may interfere with the VIDAS HIV Virus and Hepatitis C Virus Infection. Transfusion Medecine
DUO Ultra assay, were tested. The following results were Reviews. July 1997. Vol 11, N°3 p.155-172.
obtained: 8. M.Von Sydow, H.Gaines, A.Sönnerborg et al. Antigen
detection in primary HIV infection. British Medical Journal
Positive VIDAS HIV vol.296. 23 January 1988. p.238-240.
DUO Ultra results 9. A.Galetto-Lacour, S.Kinloch-de Loës, b.Hirschel et al. Primo-
anti-HAV + antibody 0/10 infection VIH: un diagnostic souvent évoqué mais posé
tardivement. Schwerz.Med Wochenschr 1995: 125 n°8.
anti-HCV + antibody 0/10 p.341-346.
anti-HBV + antibody 0/10 10. T.Meier, E.Knoll, M.Henkes et al. Evidence for a diagnostic
window in fourth generation assays for HIV. Journal of
anti-Gag + antibody 1/13 Clinical Virology vol.23, 2001, p.113-116.
anti-EBV + antibody 0/10
INDEX OF SYMBOLS
anti-HSV + antibody 0/10
Symbol Meaning
anti-CMV + antibody 0/10
anti-nuclear + antibody 0/10 Catalog number
anti-Toxoplasma gondii + antibody 0/6 In Vitro Diagnostic Medical Device
anti-Treponema pallidum + antibody 0/5
Vaccinated against influenza 0/10 Manufacturer

Vaccinated against hepatitis B 0/10

Rheumatoid factor + 0/10 Temperature limit

Children under 15 years of age 0/10

Spiking of HIV positive and HIV negative samples with Use by date
increasing concentrations of biotin (0 to 2 mg/l) did not
affect the VIDAS HIV DUO Ultra result. Batch code

WASTE DISPOSAL Consult Instructions for Use

Dispose of used or unused reagents as well as any other
contaminated disposable materials following procedures Contains sufficient for <n> tests
for infectious or potentially infectious products.
It is the responsibility of each laboratory to handle waste
and effluents produced according to their type and degree Date of manufacture
of hazardousness and to treat and dispose of them (or
have them treated and disposed of) in accordance with
any applicable regulations. WARRANTY
bioMérieux disclaims all warranties, express or implied,
LITERATURE REFERENCES including any implied warranties of MERCHANTABILITY
1. F.Barré-Sinoussi, J.C. Chermann, F.Rey et al. Isolation of T-
AND FITNESS FOR A PARTICULAR USE. BioMérieux
Lymphotropic Retrovirus from a Patient at Risk for acquired shall not be liable for any incidental or consequential
Immune Deficiency Syndrome (AIDS). 20 May 1983. damages. IN NO EVENT SHALL BIOMERIEUX’S
Science.Vol.220. page 868-871. LIABILITY TO CUSTOMER UNDER ANY CLAIM
2. F.Clavel, D.Guétard, F.Brun-Vézinet et al. Isolation of a New EXCEED A REFUND OF THE AMOUNT PAID TO
human Retrovirus from West African Patients with AIDS. 18 BIOMERIEUX FOR THE PRODUCT OR SERVICE
July 1986. SCIENCE Vol 233 page 343-346. WHICH IS THE SUBJECT OF THE CLAIM.
3. R.de Leys, B.Vanderborght, M Vanden Haesevelde and al.
Isolation and Partial Characterization of an Unusual Human
Immunodeficiency Retrovirus from Two Persons of West-
Central African Origin. Journal of Virology. Mar.1990.p1207-
1216.
4. M.Guyader, M.Emerman, P.Sonigo et al. Genome
organization and transactivation of the human
immunodeficiency virus type 2. Nature. 16 april 1987. Vol 326
p.662-669.
5. M.Popovic, M.G.Sarngadharan, E. Read et al. Detection,
Isolation, and Continuous Production of Cytopathic
Retroviruses (HTLV-III) from Patients with AIDS and Pre-
AIDS. Science. 4 May 1984. Vol.224. p 497-500.
6. World Health Organization, AIDS epidemic update.
December 2007. p 1-60.

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REVISION HISTORY
Change type categories :
N/A Not applicable (First publication)
Correction Correction of documentation anomalies
Technical change Addition, revision and/or removal of information related to the product
Administrative Implementation of non-technical changes noticeable to the user
Note: Minor typographical, grammar, and formatting changes are not included in the
revision history.
Release
Part Number Change Type Change Summary
date
INDEX OF SYMBOLS
Administrative REVISION HISTORY
2015/01 09691H CONTENT OF THE KIT (60 TESTS) – RECONSTITUTION OF
Technical REAGENTS
WARNINGS AND PRECAUTIONS
CONTENT OF THE KIT (60 TESTS) – RECONSTITUTION OF
2015/06 09691I Technical REAGENTS
INSTRUCTIONS FOR USE

BIOMERIEUX, the blue logo, SPR and VIDAS are used, pending, and/or registered trademarks belonging to bioMérieux or one of its
subsidiaries or one of its companies.
Any other name or trademark is the property of its respective owner.

673 620 399 RCS LYON

bioMérieux SA Tél. 33 (0)4 78 87 20 00
376 Chemin de l'Orme Fax 33 (0)4 78 87 20 90 0459
69280 Marcy-l'Etoile - France www.biomerieux.com