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TABLE 8

erformance of the OraQuick ADVANCE

apid HIV-1/2 Antibody Test

ith Anti-HIV 2 Performance Panel

OQ ADVANCE

Abbott HIV 1/2 Genetic Systems Bio-Rad HIV-1/

Test LN 15070PL01 LN 6650009 LN 6650592 EIA HIV 1/2 EIA HIV-2 Plus O EIA

Panel Member Result Result Result s/co s/co s/co

RRR>8.9

2R R R >8.9

3R R R >8.9

4R R R >8.9

5R R R >8.9

6R R R >8.9

7R R R >8.9

8R R R >8.9

9R R R >8.9

10 RRR>8.9

11 NR NR NR 0.3

NR = Non-Reactive; R = Reactive

TABLE 9

Performance of the OraQuick ADVANCE

Rapid HIV-1/2 Antibody Test

with Anti-HIV 1/2 Performance Panel

OQ ADVANCE

Abbott HIV 1/2 Genetic Systems Bio-Rad HIV-1/

Test LN 15070PL01 LN 6650009 LN 6650592 EIA HIV 1/2 EIA HIV-2 Plus O EIA

Panel Member Result Result Result s/co s/co s/co

1R R R >11.0

2R R R >11.0

3R R R >11.0

4R R R >11.0

5R R R >11.0

6R R R >11.0

7R R R >11.0

8R R R >11.0

9R R R >11.0

10 RRR >11.0

11 RRR >11.0

12 RRR >11.0

13 RRR >11.0

14 RRR >11.0

15 NR NR NR 0.1

NR = Non-Reactive; R = Reactive

Interfering Substances and Unrelated Medical Conditions

To assess the impact of unrelated medical conditions or interfering substances on the sensitivity of the OraQuick ADVANCE

Rapid

HIV-1/2 Antibody Test, 200 serum/plasma specimens from a variety of medical conditions unrelated to HIV-1 infection and

125 specimens with interfering substances were spiked with an HIV-1 positive specimen to give a level of reactivity in the low positive

range (see list of medical conditions and interfering substances in Table 10 below). All spiked specimens gave reactive results.

In addition, a study was performed to assess the potential effect of anticoagulants on assay sensitivity. Venipuncture whole blood

collected from 24 subjects, in each of 3 tubes containing one of three anticoagulants (EDTA, sodium heparin, and sodium citrate was

spiked with an HIV-1 positive specimen or an HIV-2 positive specimen to give a level of reactivity in the low positive range. The

HIV-1 positive samples and the HIV-2 positive samples were then aliquoted and stored 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 7 days at 2º-30ºC.

PRF

PRZ

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