Evaluation of a rapid test for the detection of antibodies to human immunodeficiency virus type 1 and 2 in the setting of multiple transmitted viral subtypes.

Rapid HIV testing is an appealing strategy in the approach to HIV diagnosis in developing countries. Concern has been raised about the use of these tests in the setting of multiple transmitted HIV subtypes. We sought to compare the OraQuick(TM) HIV-1/2 Test, a qualitative immunochromatographic test for the detection of antibodies to HIV-1 and HIV-2 using stored sera, with a conventional enzyme immunoassay (EIA)/Western blot (WB) algorithm. The study design used was a blinded retrospective study. Samples were collected on patients attending sexually transmitted disease clinics and tuberculosis clinics in Kinshasa, the Democratic Republic of Congo and included 72 known HIV seropositive and 131 known HIV seronegative subjects. All 72 known HIV seropositive samples were positive by OraQuick and all 131 known HIV seronegative samples were negative by OraQuick resulting in 100% sensitivity and specificity. We conclude that the OraQuick rapid HIV-1/2 test performs well in the setting of diverse HIV viral subtypes.