American Society for Microbiology Position on Home Use HIV-1 Testing

1. American Society for MicrobiologyPosition on Home Use HIV-1 Testing Patricia Charache, MD Johns Hopkins Medical Institutions Professor of Pathology, Medicine & Oncology

2. ASM Position OverviewHome Use HIV-1 Antibody Testing • Home use HIV-1 antibody testing removes the responsibility for assay performance, result interpretation and counseling from trained professionals. • Erroneous test performance presents a significant risk not only to subjects, but to society as at large. • Such consequences cannot be justified in the name of increased access to testing.

3. Requirements For Waived Tests Per CLIA law, waived tests must • Employ methodologies so simple and accurate that erroneous results are negligible, and b. Pose no reasonable risk of harm to the patient if the test is performed incorrectly

4. Risk of Error with a Home Test Kit • The risk of error in performing the test varies with the nature of the population(s) that purchase and try to use the kit. • With home test kits, the purchasing population cannot be controlled

5. Risks of Errors of HIV Test Performance • Ability of purchaser to read directions • Ability of purchaser to follow directions • Ability to monitor time and other test requirements • Appropriate conditions at the site of testing • Other

6. Oraquick Fluid Test: Current Harm Prevention Strategies • The manufacturer will sell the product only to laboratories that have CLIA certification that permits them to do waived tests. • CDC has established requirements that must be followed by all investigators funded by CDC for validation or other studies. These are requirements that are in addition to those that apply for other waived tests. • Some states have also added expanded requirements

7. Rates of Errors in Waived Testing Studies[From the CMS Study of Waived Testing Usage] • [CMS study in 8 states] corroborated findings of the Colorado/Ohio pilots, OIG, CDC & New York studies • 48% of waived laboratories had quality testing problems • Doctors and nurses were not following the manufacturer’s instructions/CDC QC requirements

8. Requirements For Waived Tests Per CLIA law, waived tests must • Employ methodologies so simple and accurate that erroneous results are negligible, and b. Pose no reasonable risk of harm to the patient if the test is performed incorrectly

9. Risk of Harm • The likelihood of pre-test counseling is low. • The user may not read, understand, and/or follow the directions listed in a subject brochure that describes the test, its interpretations and its follow-up needs. • Risk of failure to obtain confirmatory testing is enhanced in the absence of guidance.

10. Risk of Harm 2 • The risk of harm will vary with the likelihood that the purchaser is from a high risk population, vs. a member of the worried well, (high vs. low positive predictive value.) • The demographics of the purchaser can never be predicted. • A subject from a low risk population has a high likelihood of a false positive screening test. • False positive screening tests lead to substantial personal harm.

11. Risk of Harm 3 • Of highest concern to the American Society for Microbiology is the fact that HIV is a contagious disease. • A test error can harm not only the subject, but society as well • HIV is a spreading epidemic. ASM believes that our best current defense is accurate testing performed in association with secure counseling, and opportunity for appropriate post-test guidance and care

12. Summary • Home use HIV-1 antibody testing removes the responsibility for assay performance, result interpretation and counseling from trained professionals • Erroneous test performance presents a significant risk not only to subjects, but to society as at large. • Such consequences cannot be justified in the name of increased access to testing.