Product Manual

FINGERSTICK WHOLE BLOOD
A
specificity study was performed at eight clinical trial sites using freshly obtained fingerstick whole blood samples from
1250 previously unscreened individuals at low risk for HIV-1 infection. In the course of this study, two specimens were confirmed to
h
ave antibodies to HIV-1 and were removed from the specificity calculation. All of the remaining specimens gave non-reactive results
using the OraQuick ADVANCE
®
Rapid HIV-1/2 Antibody Test. In addition, all of the 608 HIV-1 antibody-negative specimens from
t
he 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 13.
TABLE 13
P
erformance of the OraQuick ADVANCE
®
R
apid HIV-1/2 Antibody Test on Fingerstick Whole Blood Specimens
from Individuals Presumed to be Negative for HIV Infection
O
raQuick
®
O
raQuick
Total ADVANCE
®
Licensed EIA True
T
est Group Samples Non-Reactive Non-Reactive Negative
3
L
ow-Risk 1250
1
1
248 1247
2
1
248
High-Risk 625 608 605 608
TOTAL 1875 1856 1852 1856
1
Two specimens in the low-risk study that gave reactive results using the OraQuick ADVANCE
®
test,
r
epeatedly reactive results using a licensed EIA, and positive results using a licensed Western blot were
removed from the calculation of specificity.
2
One specimen was EIA repeatedly reactive, Western blot negative.
3
True negative status based on negative or indeterminate test results using a licensed 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 1856/1856 = 100% (95% C.I. =
99.7% - 100%).
INTERFERING SUBSTANCES AND UNRELATED MEDICAL CONDITIONS
To assess the impact of unrelated medical conditions or interfering substances on the specificity of the OraQuick ADVANCE
®
Rapid HIV-1/2 Antibody Test, 321 serum/plasma specimens from a variety of medical conditions unrelated to HIV infection and
119 specimens with interfering substances were analyzed. The results of this study are shown in Table 10. One specimen from
subjects known to be positive for EBV, for HBV, or for rheumatoid factor, one from a multiparous woman, and three specimens from
known HIV infected subjects gave false positive results.
In addition, a study was performed to assess the potential effect of anticoagulants on assay specificity. Venipuncture whole blood was
collected from 24 HIV negative subjects, in each of 3 tubes containing one of the following anticoagulants: EDTA, sodium heparin,
and sodium citrate. The samples were then aliquoted and stored either refrigerated (2º-8ºC), at room temperature (18ºC) or at elevated
temperatures (30-33ºC) and tested over a 7-day period. There was no anticoagulant-specific effect observed on assay performance
with samples held up to 5 days at 2-30˚C (refer to Table 14).
17
3001-1215 0316B OQA PI US_ENG_Layout 4/14/16 2:10 PM Page 19