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As part of the oral fluid clinical studies, information was collected from the participants regarding concurrent diseases or medical

onditions, oral pathologies, non-HIV viral infections, and other factors (e.g., use of tobacco products, mouthwash within 24 hours

of testing, concomitant medications, dental fixtures, and food or drink immediately prior to testing). None of these disease states,

edical conditions or other factors interfered with test sensitivity. In a separate study of 40 individuals, consumption of alcohol,

brushing of teeth, use of mouthwash or smoking tobacco 5 minutes prior to testing, were shown to have no effect on test sensitivity.

onetheless, it is recommended that subject observes a wait period prior to oral fluid collection, according to the Oral Fluid Collection

Procedure of this package insert.

DETECTION OF ANTIBODIES TO HIV-2 IN SPECIMENS FROM INDIVIDUALS INFECTED WITH HIV-2

total of 324 serum/plasma specimens reported to be HIV-2 antibody positive were obtained from various repository sources.

Specimens were tested by licensed anti-HIV-1/2 EIA, licensed anti-HIV-2 EIA, licensed HIV-1 Western blot, an HIV-2 Western blot

and HIV-2 specific PCR. A total of 6 specimens were not demonstrated to be positive for antibodies to HIV-1 or HIV-2, all of which

ere OraQuick ADVANCE

on-reactive. Two of the 6 negative specimens were repeatedly reactive by licensed anti-HIV-1/2 EIA,

negative by licensed anti-HIV-2 EIA, and indeterminate by licensed HIV-1 Western blot and by an HIV-2 Western blot.

Of the remaining 318 specimens, 151 were positive on an HIV-2 Western blot and 50 were positive using an HIV-2 specific PCR. One

undred and twenty-two specimens gave confirmatory results consistent with HIV-1 infection and were excluded from the analysis.

One specimen was categorized as a dual infection based on additional testing by co-culture, and was not included in the sensitivity

analysis. One specimen, while indeterminate on HIV-1 and HIV-2 Western blots, gave a positive result on an HIV-2 radioimmuno-

precipitation assay (RIPA) and is also considered to be positive for antibodies to HIV-2. OraQuick ADVANCE

detected 201/201

(100%) of the specimens from individuals confirmed as positive for HIV-2 antibodies (see Table 10).

In a separate study, a total of 499 plasma specimens collected from an HIV-2 endemic area (Ivory Coast) were prepared as contrived

whole blood and tested by OraQuick ADVANCE

, licensed anti-HIV-1/2 EIA, licensed anti-HIV-2 EIA, licensed HIV-1 Western blot,

and an HIV-2 Western blot. Table 9 shows a summary of the results. OraQuick ADVANCE

was reactive with all of the 27 specimens

that were repeatedly reactive by licensed anti-HIV-1/2 EIA, licensed anti-HIV-2 EIA and positive on licensed HIV-1 Western blot, and

with all three specimens that were confirmed as positive for HIV-2 only by an HIV-2 Western blot. Two specimens were OraQuick

ADVANCE

false positive.

TABLE 10

Detection of Antibody to HIV-2 in Samples from HIV-2 Seropositive Individuals and

Individuals at High Risk of HIV-2 Infection

Licensed anti-

HIV-2 EIA

OraQuick Repeatedly

Total ADVANCE

Reactive or HIV-2 True HIV-2

Test Group Samples Reactive PCR Positive Positive

Known HIV-2

Positive 324

201 201

201

High-Risk 499 32 33 3

TOTAL 823 233 234 204

Confirmation performed by HIV-2 Western blot, with RIPA confirmation of Indeterminate Western blot results.

One hundred and twenty-two specimens gave confirmatory results consistent with HIV-1 infection and were

excluded from the analysis. In addition, one specimen was categorized as a dual infection based on additional

testing by co-culture, and was not included in the sensitivity analysis.

151 specimens were tested with an anti-HIV-2 EIA alone. HIV-2 DNA or RNA PCR was performed on the

remaining 50 specimens instead of EIA. All results were positive.

One specimen was confirmed to be HIV-2 positive based on the positive results of an HIV-2 specific RIPA.

Combining the number of OraQuick ADVANCE

reactive results obtained from the study of confirmed positives with the

number of

OraQuick ADVANCE

reactive results obtained from the study of the high risk population, the sensitivity of the

OraQuick ADVANCE

Rapid HIV-1/2 Antibody Test for the detection of antibodies to HIV-2 in these studies was calculated to be

204/204 = 100% (95% C.I. = 98.2% - 100%).

In addition, 3 HIV-2 infected individuals located in the USA were tested by fingerstick whole blood and oral fluid OraQuick

ADVANCE

tests. Fingerstick whole blood and oral fluid samples from all three subjects were reactive on the OraQuick ADVANCE

test.

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