OTC Home-Use HIV Kits: ASM Considerations

1. OTC Home-Use HIV Kits:ASM Considerations Patricia Charache Professor, Pathology, Medicine and Oncology ASM Representative

2. Issues of Concern for OTC Use • Ability of users to correctly perform the test • CMS evidence shows in general use, waived tests give inaccurate results (33-50% in MD offices) • Impact of loss of direct counseling on subsequent clinical and epidemiologic follow-up and support • Documentation of risk of harm data when test is performed by the untrained and unobserved public with loss of current testing and support controls.

3. Accuracy Considerations • Home testing can be expected to yield both false negatives and positives, (specimen collection, 20 min. incubation, etc). • Consider low risk, as well as high risk populations, e.g. the worried well, a large population for whom the significance of harm due to false positives must not be undervalued. • An oral test study showed a 50% false positive predictive value rate; this should be further assessed; predictive values should be considered given unpredictable usage.

4. Safety Considerations • Direct pre-and post test counseling would not be available to OTC users • Documentation is required to show that users would take advantage of telephone or web-based support services. The use by anonymous mail in participants appear to have been low, (e.g. mail in HIV and HCV tests). • It may be reasonable to learn how introduction of such tests impact upon confirmatory testing and follow-up care without pre-test or post-test counseling

5. Risk of Equating Waived Test Studiesand OTC Usage • Rates of % patients who return for follow-up: Waived test studies were primarily performed in settings in which subjects received pre-test and/or post-test counseling. • CDC funded studies, as well as states require added safety controls to the use of waived tests. Per Dr. Branson, is there information available on the impact of over-riding such controls

6. Assessment of Effect of False Positive as well as False Negative Tests • Patient harm associated with false negatives is clear, however the significance patient harm due to false positive results should not be undervalued. • The fact that an oral test study showed a 50% false positive predictive value rates should be further assessed. • The criteria to be used by the FDA should be understood in the context of study findings prior to final decision making.