Pilot of non-invasive (oral fluid) testing for HIV within a clinical setting

Abstract

Background: The objectives of the present study were: to determine the sensitivity and specificity of oral fluid testing compared with the performance of standard blood-based HIV enzyme immunoassay; to assess the feasibility of oral fluid specimen collection from clients for the purposes of HIV testing within a clinical setting; and to assess the clinical and laboratory impact regarding staffing, material resources, expertise and funding of oral fluid testing. Methods: A parallel comparative trial of oral fluid and blood testing was conducted among a group of HIV positive clients and a group of unknown HIV serostatus clients where each client was offered both tests. An ambulatory HIV clinic recruited 175 known HIV positive clients and 179 persons were recruited through an inner city sexual health clinic while attending for routine sexual health checks. Client responses to oral fluid collection were assessed. The sensitivity and specificity of oral fluid testing were calculated. Results: Of the 176 confirmed HIV reactive blood test results, the OraSure (OraSure Technologies, Beaverton, OR, USA) assay failed to detect only one of these, demonstrating a sensitivity of 99.4%. Of the 178 blood specimens that were tested as non-reactive by the AxSYM (Abbott Laboratories, Abbott Park, IL, USA) Combo system, OraSure recorded four of the corresponding oral fluid specimens as reactive (assumed to be false-positive), giving a specificity of 97.6%. Although evaluation of patients undergoing the test showed a large proportion (88.6%) preferred the OraSure test to conventional blood testing, a large minority of these (22.6%) made such a preference conditional on the OraSure test being as reliable as current blood testing. Conclusions: This limited clinic based trial of oral fluid testing for HIV antibodies among an outpatient population has demonstrated the potential of oral fluid as a specimen for HIV testing. However, the lower performance of the test compared with current serum-based tests may limit the usefulness of OraSure to epidemiological studies or as an alternative screening tool in outreach settings among higher risk populations.