Product Manual

PERFORMANCE CHARACTERISTICS
SENSITIVITY
DETECTION OF ANTIBODIES TO HIV-1 IN SPECIMENS FROM INDIVIDUALS INFECTED WITH HIV-1
O
RAL FLUID
A sensitivity study was performed at eight clinical trial sites using freshly obtained oral fluid specimens collected from 767 individuals
r
eported to be infected with HIV-1. Of the 767 specimens that were identified as seropositive using licensed confirmatory testing, 762
gave a reactive result on the OraQuick ADVANCE
®
Rapid HIV-1/2 Antibody Test. The results of this study are shown in Table 1.
A separate study was performed at four clinical trial sites using freshly obtained oral fluid specimens collected from 3150 previously
unscreened individuals from populations at high risk for HIV-1 infection. The results of this study are also shown in Table 1. Of the
7
3 specimens that were identified as seropositive using licensed confirmatory testing, 72 were reactive using the OraQuick
ADVANCE
®
Rapid HIV-1/2 Antibody Test.
TABLE 1
D
etection of Antibody to HIV-1 in Oral Fluid Specimens from HIV-1 Seropositive Individuals
OraQuick Licensed EIA
Total ADVANCE
®
Repeatedly
Test Group Samples Reactive Reactive True Positive
1
Known HIV-1
Positive 767 762 764 767
High-Risk 3150 72
2
74
3
73
TOTAL 3917 834 838 840
1
Confirmation performed by licensed HIV-1 Western blot, with confirmation of indeterminate Western blot results
by licensed immunofluorescence assay (IFA).
2
Eight additional specimens were OraQuick ADVANCE
®
false positive (see Table 7).
3
One specimen was EIA false positive, with a negative Western blot.
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 high-risk populations, the sensitivity of the OraQuick
ADVANCE
®
Rapid HIV-1/2 Antibody Test in these studies was calculated to be 834/840 = 99.3% (95% C.I. = 98.4% - 99.7%).
PLASMA
A sensitivity study was performed at eleven clinical trial sites using EDTA-plasma specimens collected from 891 individuals reported
to be infected with HIV-1. Of the 891 specimens that were identified as seropositive using licensed confirmatory testing, 887 gave a
reactive result on the OraQuick ADVANCE
®
Rapid HIV-1/2 Antibody Test. The results of this study are shown in Table 2.
A separate study was performed at six clinical trial sites using EDTA-plasma specimens collected from 533 previously unscreened
individuals from populations at high risk for HIV-1 infection. The results of this study are also shown in Table 2. All of the 14
specimens that were identified as seropositive using licensed confirmatory testing, were reactive using the OraQuick ADVANCE
®
Rapid HIV-1/2 Antibody Test.
TABLE 2
Detection of Antibody to HIV-1 in Plasma Specimens from HIV-1 Seropositive Individuals
OraQuick Licensed EIA
Total ADVANCE
®
Repeatedly
Test Group Samples Reactive Reactive True Positive
1
Known HIV-1
Positive 891 887 891 891
High-Risk 533 14
2
14 14
TOTAL 1424 901 905 905
1
Confirmation performed by licensed HIV-1 Western blot, confirmation of indeterminate Western blot results
by radioimmunoprecipitation assay (RIPA) or licensed IFA.
2
One additional specimen was OraQuick ADVANCE
®
false positive (see Table 8).
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 high-risk populations, the sensitivity of the OraQuick
ADVANCE
®
Rapid HIV-1/2 Antibody Test in these studies was calculated to be 901/905 = 99.6% (95% C.I. = 98.9% - 99.8%).
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