Diagnostic challenges for rapid human immunodeficiency virus assays. Performance using HIV-1 group O, HIV-1 group M, and HIV-2 samples

Abstract

Objective: We sought to determine the ability of seven rapid assays for human immunodeficiency virus (HIV) to detect antibodies in a panel of sera from individuals infected with different types and groups of HIV.

Study design/methods: Sixty-eight well-characterized samples, including HIV-1 group O (24), several HIV-1 group M clades (21), HIV-1/2 (10), HIV-2 (10), and samples with indeterminate results (3), were tested by the following rapid HIV assays: HIV-Spot, HIVCHEK System 3, A/Q Rapid HIV, Genie II HIV-1/HIV-2, Quix HIV-1-2-O, ImmunoComb II HIV-1+2 BiSpot, and the Serodia HIV-1+2.

Results: All tests successfully detected the HIV-1 group M clades and the HIV-1/2-positive samples. Of the HIV-2 stand-alone samples, four tests missed the same sample, and three tests missed another sample. Of the HIV-1 group O samples, four samples were missed by at least one test, and another sample was missed by three tests. The sensitivity of the seven rapid assays in detecting each group of sera was between 83% and 100%, with only one test having a sensitivity of 100% for all groups of sera. Three samples proved to be problematic because they were misclassified by more than one assay.

Conclusions: The performance of rapid HIV assays is variable when testing sera from individuals infected with HIV-1 group O and HIV-2.