OTC Home-Use HIV Kits: ASM Considerations

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OTC Home-Use HIV KitsASM Considerations

• Patricia Charache
• Professor, Pathology, Medicine and Oncology ASM
  Representative

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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.

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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.

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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

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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

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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.