Sensitivity of five rapid HIV tests on oral fluid or finger-stick whole blood: a real-time comparison in a healthcare setting.

BACKGROUND: Health authorities in several countries recently recommended the expansion of human immunodeficiency virus (HIV) antibody testing, including the use of rapid tests. Several HIV rapid tests are now licensed in Europe but their sensitivity on total blood and/or oral fluid in routine healthcare settings is not known. METHODS AND FINDINGS: 200 adults with documented HIV-1 (n=194) or HIV-2 infection (n=6) were prospectively screened with five HIV rapid tests using either oral fluid (OF) or finger-stick whole blood (FSB). The OraQuick Advance rapid HIV1/2 was first applied to OF and then to FSB, while the other tests were applied to FSB, in the following order: Vikia HIV 1/2, Determine HIV 1-2, Determine HIV-1/2 Ag/Ab Combo and INSTI HIV-1/HIV-2. Tests negative on FSB were repeated on paired serum samples. Twenty randomly selected HIV-seronegative subjects served as controls, and the results were read blindly. Most patients had HIV-1 subtype B infection (63.3%) and most were on antiretroviral therapy (68.5%). Sensitivity was 86.5%, 94.5%, 98.5%, 94.9%, 95.8% and 99% respectively, with OraQuick OF, OraQuick FSB, Vikia, Determine, Determine Ag/Ab Combo and INSTI (p<0.0001). OraQuick was less sensitive on OF than on FSB (p=0.008). Among the six patients with three or more negative tests, two had recent HIV infection and four patients on antiretroviral therapy had undetectable plasma viral load. When patients positive in all the tests were compared with patients who had at least one negative test, only a plasma HIV RNA level<200 cp/ml was significantly associated with a false-negative result (p=0.009). When the 33 rapid tests negative on FSB were repeated on serum, all but six (5 negative with OraQuick, 1 with INSTI) were positive. The sensitivity of OraQuick, Determine and Determine Ag/Ab Combo was significantly better on serum than on FSB (97.5%, p=0.04; 100%, p=0.004; and 100%, p=0.02, respectively). CONCLUSION: When evaluated in a healthcare setting, rapid HIV tests were less sensitive on oral fluid than on finger-stick whole blood and less sensitive on finger-stick whole blood than on serum.

Sensitivity of 8 CE (European Community)-approved rapid disposable tests for anti-HIV antibody detection during and after seroconversion.

UNLABELLED: We evaluated the sensitivity for the anti-HIV antibody detection of the 8 rapid disposable tests (RDTs) EC approved in 2008. METHODS: A panel of 100 native serum samples collected from HIV-1 subtype B or non-B, HIV-1 group O or HIV-2-infected patient and 3 commercial seroconversion panels were tested. 50 sera from HIV-negative patients were included to blind reading and RDT specificity. RESULTS: All native samples HIV-1 subtype B were reactive; an HIV-1 non-B subtype gave false-negative results with 3 of the 8 tests. False-negative results on HIV-1 group O samples were observed with one RDT. All the HIV-2 samples were detected. Seroconversion sample reactivity ranged from 60 to 86.7% according to the tests. CONCLUSION: Despite their lower performances relative to ELISA tests during the HIV seroconversion period, RDT may be of interest in case of chronic infection.