HIV point-of-care diagnostics: meeting the special needs of sub-Saharan Africa.
BACKGROUND Since 2002, the US Food and Drug Administration has approved 6 rapid human immunodeficiency virus (HIV) tests for use in the United States. To date, there has been no direct comparison of the performance of all 6 tests. METHODS Persons known to be HIV-infected and persons who sought HIV testing at 2 clinical sites in Los Angeles, California, were recruited for evaluation of 6 rapid HIV tests with whole blood, oral fluid, serum, and plasma specimens. Sensitivity and specificity of the rapid tests were compared with viral lysate and immunoglobulin (Ig) M-sensitive peptide HIV enzyme immunoassays (EIAs). RESULTS A total of 6282 specimens were tested. Sensitivity was >95% and specificity was >99% for all rapid tests. Compared with the IgM-sensitive EIA, rapid tests gave false-negative results with an additional 2-5 specimens. All rapid tests had statistically equivalent performance characteristics, based on overlapping confidence intervals for sensitivity and specificity, compared with either conventional EIA. CONCLUSIONS All 6 rapid tests have high sensitivity and specificity, compared with that of conventional EIAs. Because performance was similar for all tests and specimen types, other characteristics, such as convenience, time to result, shelf life, and cost will likely be determining factors for selection of a rapid HIV screening test for a specific application.