American Society for American Society for MicrobiologyMicrobiology

Position on Home Use HIV-1 TestingPosition on Home Use HIV-1 Testing

Patricia Charache, MDJohns Hopkins Medical Institutions

Professor of Pathology, Medicine & Oncology

ASM Position OverviewASM Position Overview Home Use HIV-1 Antibody Testing Home 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.

Requirements For Waived TestsRequirements For Waived Tests

Per CLIA law, waived tests must

a. 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

Risk of Error with a Home Test KitRisk 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

Risks of Errors of HIV Test Risks of Errors of HIV Test PerformancePerformance

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

Oraquick Fluid Test: Oraquick Fluid Test: Current Harm Prevention StrategiesCurrent 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

Rates of Errors in Waived Testing StudiesRates 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

Requirements For Waived TestsRequirements For Waived Tests

Per CLIA law, waived tests must

a. 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

Risk of HarmRisk 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.

Risk of Harm 2Risk 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.

Risk of Harm 3Risk 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

SummarySummary

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.