Performance of rapid point-of-care and laboratory tests for acute and established HIV infection in San Francisco

Abstract

Background: Current laboratory and point-of-care tests for HIV detect different analytes and use different sample types. Some have fast turnaround times (<1 hour). We investigated how HIV test choice could impact case finding by testing programs.

Methods: We analyzed 21,234 consecutive HIV tests with venous blood obtained by San Francisco HIV testing programs from 2003 to 2008. For a subset, oral fluid (n = 6446) or fingerstick blood (n = 8127) samples were also obtained for rapid testing. In all cases, HIV status was determined using an HIV antibody-plus-RNA test algorithm. We assessed how the screening antibody tests performed individually versus the gold standard of the full algorithm. We then evaluated the potential ability of other tests (including new tests) to detect more cases, by re-testing all specimens that had negative/discrepant antibody results on initial screening.

Findings: The antibody-RNA algorithm identified 58 acute and 703 established HIV infection cases. 1(st)-generation (Vironostika) and 3(rd)-generation (Genetic Systems) immunoassays had 92 and 96 percent sensitivity, respectively. The Oraquick rapid test had clinical sensitivity of only 86 percent on oral fluid samples, but 92 percent on finger-stick blood. Newer 4(th)-generation, antigen-antibody combo rapid immunoassay (ARCHITECT) detected HIV in 87 percent of all the acute cases that had been missed by one of the previous screening assays. A point-of-care 4(th) generation antigen-antibody combo rapid test (Determine) detected about 54 percent of such acute cases.

Conclusions: Our study suggests that some rapid antibody blood tests will give similar case detection to laboratory antibody tests, but that oral fluid testing greatly reduces ability to detect HIV. New 4(th)-generation combo tests can detect the majority of acute infections detectable by HIV RNA but with rapid results. Using these tests as a primary screening assay in high-risk HIV testing programs could reduce or eliminate the need for HIV RNA testing.

Figure 1. Clinical Testing Algorithm, San Francisco Targeted Testing Programs 2003–2008 (adapted from [6]).

Figure 2. Estimated Impact of Test Performance on Detection of Acute (black) and Established (grey) HIV Infection Cases in San Francisco Targeted Testing Programs.

For all blood assays, figures shown represent results shown in Table 3. For the Oraquick Advance assay, oral fluid results (Table 2) are not shown.