Comparison of the performance of rapid HIV tests using samples collected for surveillance in Mozambique.

Mozambique had low HIV prevalence until the mid-1990s, but recent data indicate increasing rates. There is little information on HIV-2. Therefore, HIV seroprevalence was assessed among pregnant women and field-ready HIV diagnostic strategies were evaluated. A total of 6,930 samples collected by three health centers from 2002 to 2005 were tested on site by nurses with two simple/rapid tests, Determine HIV-1/2 (Abbott Laboratories; screening) and Uni-Gold HIV (Trinity Biotech; confirmation), which is the national HIV testing strategy. The prevalence of HIV was 14.0% (2002), 17.8% (2003), 16.5% (2004), and 20.2% (2005). A subset of 888 samples collected 2003 was sent to the Central Microbiology Laboratory, Maputo for evaluation of tests and testing strategies. The assays included for comparison were Capillus HIV-1/HIV-2 (Trinity Biotech), DoubleCheckGold HIV-1&2 (Orgenics) and Enzygnost Anti-HIV-1/2 Plus (Behringwerke, reference ELISA). Confirmation of reactive samples was done by Uni-Gold HIV and ImmunoComb II HIV-1&2 BiSpot (for HIV type differentiation). The Capillus HIV-1/ HIV-2 + ImmunoComb II HIV-1&2 BiSpot combination was the gold standard. The sensitivity of the rapid/simple screening assays (Determine HIV-1/2, DoubleCheckGold HIV-1&2) was 100% (N = 160) and their (initial) specificities were 99.6% and 99.7%, respectively. Repeated testing and combinations of assays increased the specificity. Four suspected cases of recent seroconversion were found. Together with the increasing prevalence rates, this may indicate that Mozambique is a high-incidence area, although further studies are needed to confirm this. Testing strategies for on-site screening and confirmation based on the combination of Determine HIV-1/2, Uni-Gold HIV and DoubleCheckGold HIV-1&2 are well suited for local field use.