TUPE187 - Poster Exhibition
Development of an oral fluid self-test for HIV infection: evaluation in a population of unknown risk
S. Lee, M. Roehler, T. Miller, K. Kardos, A. Almeidasantos, R. Gregg
OraSure Technologies, Inc., Bethlehem, United States
Background: In March 2006, FDA and its Blood Products Advisory Committee (BPAC) endorsed the general study requirements to gain approval of a self-test for HIV to be sold over-the-counter (OTC). We report here on the development of an OTC HIV test and the results of studies of its utility and performance in the hands of intended users.
Methods: The HIV OTC test was developed based on the oral fluid application of the FDA approved and CLIA-waived OraQuick® ADVANCE Rapid HIV-1/2 test Packaging and labeling was designed in an iterative process to enable intended users to self-select and correctly conduct the test and interpret their self-test results. In addition, a 24/7 call center was developed to assist consumers in running the test and to provide referrals to appropriate medical care. Quantitative label comprehension studies were conducted in intended user populations. The ability of users to correctly self-test was studied in 500 subjects at unknown risk for HIV, where testing could be observed and results compared with professional testing by FDA approved tests.
Results: Rates of correct label comprehension were high across all major categories at 98.8% (95% CIs: 97.4-99.6%) for the intended use of the product and 98.6% (97.1-99.4%) for the concept of the HIV “window” phase. In the observed self testing study, twelve individuals (2.4%) newly identified themselves as HIV positive and 95.6% correctly identified themselves as HIV negative. Overall specificity of the investigational self-test was 99.8% (98.1-100%). Only 1.8% of users failed to obtain a result due to testing error.
Conclusions: These results indicate a suitably designed HIV self-test can be used effectively by untrained consumers. An OTC HIV test can be a critical additional tool in fighting the HIV epidemic and help reduce stigma associated with HIV/AIDS.
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