Product Manual

FINGERSTICK WHOLE BLOOD
A
sensitivity study was performed at eight clinical trial sites using freshly obtained fingerstick whole blood samples from 481
individuals known to be infected with HIV-1 and 40 AIDS patients. Of the 521 specimens that were repeatedly reactive using a licensed
E
IA and positive by Western blot, 519 gave a reactive result on the OraQuick ADVANCE
®
R
apid HIV-1/2 Antibody Test. The results
of this study are shown in Table 3.
A separate study was performed at seven clinical trial sites using 625 freshly obtained fingerstick whole blood samples from
previously unscreened individuals from populations at high risk for HIV-1 infection. The results of this study are also shown in Table 3.
O
f the 625 specimens tested, 20 were repeatedly reactive using a licensed EIA, of which 17 were positive by Western blot. These same
17 specimens gave a reactive result using the OraQuick ADVANCE
®
Rapid HIV-1/2 Antibody Test.
T
ABLE 3
Detection of Antibody to HIV-1 in Fingerstick Whole Blood Samples from Patients with AIDS and
f
rom HIV-1 Seropositive Individuals
OraQuick Licensed EIA
T
otal ADVANCE
®
R
epeatedly
Test Group Samples Reactive Reactive True Positive
1
AIDS 40 40 40 40
Known HIV-1
Positive 481 479 481 481
High-Risk 625 17 20
2
17
TOTAL 1146 536 541 538
1
Confirmation performed by licensed HIV-1 Western blot, with confirmation of indeterminate Western blot
results by RIPA.
2
Two specimens were negative and one was indeterminate on Western blot with a negative 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 high-risk populations, the sensitivity of the OraQuick ADVANCE
®
Rapid HIV-1/2 Antibody Test in these studies was calculated to be 536/538 = 99.6% (95% C.I. = 98.5% - 99.9%).
Reactivity with HIV-1 Specimens From Various Geographic Regions
To assess the sensitivity of the OraQuick ADVANCE
®
Rapid HIV-1/2 Antibody Test for HIV-1 variants from various geographic
regions, 215 confirmed HIV-1 antibody-positive serum/plasma specimens were obtained from various parts of the world. Of these
215 specimens, 214 were reactive using the OraQuick ADVANCE
®
Rapid HIV-1/2 Antibody Test. One confirmed HIV-1 antibody-
positive specimen from China was non-reactive using the OraQuick ADVANCE
®
test. An additional 13 specimens representing
HIV-1 Subtypes A, B, C, D, F, and G, and Group O were tested and reactive on OraQuick ADVANCE
®
.
Reactivity with HIV-1 Seroconversion Panels
Twenty-three (23) HIV-1 seroconversion panels were tested with three (3) lots of OraQuick
®
product and compared to certified
3
r
d
Generation HIV EIA results. Each panel consisted of sequential serum/plasma specimens obtained from a single individual during
seroconversion. The twenty-three (23) seroconversion panels consisted of 202 specimens. The results of this study are shown in
Tables 4 & 5. In this study, the OraQuick ADVANCE
®
Rapid HIV-1/2 Antibody Test was demonstrated to be capable of detecting
seroconversion within 1.48 days of licensed 3rd Generation HIV EIAs.
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