Product Manual

SPECIFICITY
ORAL FLUID
A specificity study was performed at four clinical trial sites using freshly obtained oral fluid specimens collected from 605 previously
u
nscreened individuals at low risk for HIV-1 infection. All of the 605 specimens were correctly non-reactive using the OraQuick ADVANCE
®
Rapid HIV-1/2 Antibody Test. Of the 3077 HIV antibody-negative specimens from the four study sites that examined populations at high
risk for HIV-1 infection, the OraQuick ADVANCE
®
test was non-reactive for 3069. The results are summarized in Table 11.
TABLE 11
P
erformance of the OraQuick ADVANCE
®
R
apid HIV-1/2 Antibody Test on Oral Fluid Specimens
from Individuals Presumed to be Negative for HIV Infection
OraQuick
T
otal ADVANCE
®
L
icensed EIA True
Test Group Samples Non-Reactive Non-Reactive Negative
1
L
ow-Risk 605 605 599
2
6
05
H
igh-Risk 3150 3069
3
3
076
4
3
077
TOTAL 3755 3674 3675 3682
1
Confirmation performed by licensed HIV-1 Western blot, with confirmation of indeterminate Western blot
results by RIPA or IFA.
2
Six specimens were EIA false positive, five with a negative Western blot and one with an indeterminate blot
which was confirmed negative by IFA.
3
One additional specimen was OraQuick ADVANCE
®
false negative (see Table 1).
4
One specimen was EIA false positive with a negative Western blot.
Combining the number of OraQuick ADVANCE
®
non-reactive results obtained from the study of the low-risk populations with
the number of OraQuick ADVANCE
®
non-reactive results obtained from the study of the high-risk populations, the specificity of
the OraQuick ADVANCE
®
Rapid HIV-1/2 Antibody Test in these studies was calculated to be 3674/3682 = 99.8% (95% C.I. = 99.6%
- 99.9%).
PLASMA
A specificity study was performed at seven clinical trial sites using EDTA-plasma specimens collected from 1102 previously
unscreened individuals at low risk for HIV infection. All of the specimens, except for one, gave non-reactive results using the OraQuick
ADVANCE
®
Rapid HIV-1/2 Antibody Test. In addition, 519 of the 520 HIV antibody-negative specimens from study sites that
examined populations at high risk for HIV-1 infection also gave non-reactive results using the OraQuick ADVANCE
®
test. The results
of this study are shown in Table 12.
TABLE 12
Performance of the OraQuick ADVANCE
®
Rapid HIV-1/2 Antibody Test on Plasma Specimens
from Individuals Presumed to be Negative for HIV Infection
OraQuick
Total ADVANCE
®
Licensed EIA True
Test Group Samples Non-Reactive Non-Reactive Negative
1
Low-Risk 1102 1101 1096
2
1102
High-Risk 534 519 516
3
520
TOTAL 1636 1620 1612 1622
1
Confirmation performed by licensed HIV-1 Western blot, with confirmation of indeterminate Western blot
results by RIPA or IFA.
2
Six specimens were EIA false positive, five with a negative Western blot and one with an indeterminate blot
which was confirmed negative by IFA
3
Four specimens were EIA false positive, with 1 negative and 3 indeterminate by Western blot, that confirmed
negative by IFA.
Combining the number of OraQuick ADVANCE
®
non-reactive results obtained from the study of the low-risk populations with
the number of OraQuick ADVANCE
®
non-reactive results obtained from the study of the high-risk populations, the specificity
of the OraQuick ADVANCE
®
Rapid HIV-1/2 Antibody Test in these studies was calculated to be 1620/1622 = 99.9% (95% C.I. =
99.6% - 99.9%).
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