Abstract

BackgroundCurrent 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.MethodsWe 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.FindingsThe antibody-RNA algorithm identified 58 acute and 703 established HIV infection cases. 1st-generation (Vironostika) and 3rd-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 4th-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 4th generation antigen-antibody combo rapid test (Determine) detected about 54 percent of such acute cases.ConclusionsOur 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 4th-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.

Highlights

  • A substantial number of individuals seek HIV screening at HIV testing sites during the earliest, acute phase of HIV infection, when HIV antibody responses are evolving [1,2,3,4,5,6]

  • 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 4th-generation combo tests can detect the majority of acute infections detectable by HIV RNA but with rapid results

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Summary

Introduction

A substantial number of individuals seek (or are referred for) HIV screening at HIV testing sites during the earliest, acute phase of HIV infection, when HIV antibody responses are evolving [1,2,3,4,5,6]. Traditional HIV antibody test screening misses between 1 and 13 percent of cases of HIV infection that are potentially detectable through HIV testing programs ([1,2,3,4,5,6]; reviewed in [7]). Identifying such individuals as HIVinfected is an important public health concern because the potential for sexual transmission is very high [8,9,10], and very early treatment might confer clinical benefits [11]. We investigated how HIV test choice could impact case finding by testing programs

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