Product Manual
TABLE 5
S
ummary of the Delay in Days of Detection of Seroconversion Specimens with the
O
raQuick ADVANCE
®
R
apid HIV-1/2 Antibody Test in Comparison to 3
r
d
G
eneration anti-HIV EIA Tests
Number Number
Number of Detected Detected Average Average Delay Days
Number Concordant Earlier by Earlier by Days Days (OraQuick
o
f Panels Results OraQuick EIA OraQuick EIA - EIA)
1.48
23 7313 36.46 34.99 (95% CI: -0.1
t
o 3.1 days)
Reactivity with HIV-1 Low Titer Panels
T
hree (3) low titer HIV-1 antibody panels were tested in comparison with licensed anti-HIV EIA tests. The low titer HIV-1 antibody
panels consisted of 50 serum/plasma specimens. The results of this study are shown in Table 6. An anti HIV mixed titer panel containing
25 specimens was tested with results provided in Table 7. An anti HIV-2 performance panel was tested containing 11 specimens, with results
p
rovided in Table 8. Additionally an anti-HIV 1/2 performance panel was tested containing 15 specimens with results provided in Table 9. In
these studies, three (3) lots of OraQuick ADVANCE
®
Rapid HIV-1/2 Antibody Tests demonstrated capability of detecting antibodies to HIV-1
similar to currently available FDA licensed EIAs.
TABLE 6
Performance of the OraQuick ADVANCE
®
Rapid HIV-1/2 Antibody Test
with Anti-HIV 1 Low Titer Performance Panel
OQ ADVANCE
®
OQ ADVANCE
®
OQ ADVANCE
®
Abbott HIV 1/2 Genetic Systems Bio-Rad HIV-1/
T
est LN 15070PL01 LN 6650009 LN 6650592 EIA HIV 1/2 EIA HIV-2 Plus O EIA
P
anel Member Result Result Result s/co s/co s/co
1R NR NR 6.6 0.4
2R R R 3.7 1.0
3 NR NR NR 4.5 0.3
4R R R 9.7 1.0
5 NR NR NR 0.1 0.1
6R R R 7.3 2.4
7R R R 1.0 0.3
8R R R 7.1 1.8
9R R R 2.4 0.3
10 RRR3.5 2.5
11 RRR3.3 7.0
12 NR NR NR 5.0 0.1
13 RRR3.3 0.4
14 RRR14.3 7.0
15 RRR2.7 6.4
1R R R 10.4 3.9
2 NR NR NR 0.2 0.2
3R R R 9.3 3.2
4R R R 15.7 8.1
5R R R 4.8 6.2
6R R R 6.4 4.4
7R R R 7.3 2.2
8R R R 11.0 5.0
9R R R 11.8 2.1
10 RRR9.6 0.5
11 RRR10.1 8.2
12 NR NR NR 2.8 0.1
13 RRR13.1 0.3
14 R NR NR 9.6 0.3
15 RRR16.2 7.7
NR = Non-Reactive; R = Reactive
12
PRB
107
PRB
108
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