Figure 1. HIV-Testing Algorithm and Exclusion criteria Survey 1.
In Survey 1 we tested 1,889 whole blood specimen and 14,448 plasma specimen with the Determine HIV1/2 RDT. The confirmation algorithm included two different ELISAs and one Western Blot. If both ELISAs were in agreement their result was used as the reference standard result. Samples with discordant ELISA results were retested by Western Blot and the Western Blot result used. Samples with indeterminate Western Blot results were excluded from analysis. Negative RDT results were not directly confirmed, but regarded as true negative if the result of the following survey was also negative. Whole blood results where confirmation by ELISA testing was impossible due to lack of plasma, were regarded as true positive if the result in the next survey was confirmed positive and as false positive if a negative test result in the next survey was confirmed using the above reference algorithm. Results where the true HIV status could not be verified according to the reference algorithm were excluded from this analysis.