Performance of the Determine Ag/Ab Combo test.

<p>Group 1: Antigen positive, antibody negative acute HIV infection (Ag+Ab−).</p><p>Group 2: Antigen positive, antibody positive early HIV infection (Ag+Ab+).</p><p>Group 3: Antigen negative, antibody positive chronic HIV infection (Ag−Ab+).</p><p>Group 4: Antigen negative, antibody negative volunteers without HIV infection (Ag−Ab−).</p><p>Group 5: Antigen false positive, antibody negative volunteers without HIV infection (Ag−Ab−).</p><p>Ag: p24 antigen, Ab: HIV antibody, weak pos: the respective assay indicator was fainter than the control indicator. This is considered “positive” in our analyses, as per the package insert.</p

Comparison of the p24 ELISA (Vironostika) and Combo test (antigen component) against serially diluted p24 antigen-positive controls.

*<p>Average OD (Optical Density) of two runs. An OD ≥0.10 is considered a positive result.</p

ELISA p24 Antigen Concentration and Viral Load Summary Statistics.

*<p>Upper limit of detection for the VL assay  = 15,000,000, any observation that exceeded 15,000,000 recorded as 15,000,001.</p><p>Group 1: Antigen positive, antibody negative i.e. acute HIV infection (Ag+ Ab−).</p><p>Group 2: Antigen positive, antibody positive i.e. early HIV infection (Ag+ Ab+).</p