Mapping Pathways is a multi-national project to develop and nurture a research-driven, community-led global understanding of the emerging evidence base around the adoption of antiretroviral-based prevention strategies to end the HIV/AIDS epidemic. The evidence base is more than results from clinical trials - it must include stakeholder and community perspectives as well.

13 June 2012

Advisory Committee Recommends FDA Approval of In-Home HIV Test

via, by Cassandra Willyard

Last month, patient advocates hailed the unanimous vote by an advisory committee to the US Food and Drug Administration that recommended that the agency approve the OraQuick In-Home HIV test, an over-the-counter diagnostic that can be taken without medical supervision. If approved, the OraQuick test would be the first home test approved for an infectious disease. But concerns remain about whether the price will render it out of reach of those who need it most and what the test will mean for the handful of individuals participating in HIV vaccine trials.

The OraQuick test, from Pennsylvania-based OraSure Technologies, is a home version of a rapid HIV test already used in many medical centers. The kit includes an instructional booklet and a test stick, which the user swipes along his or her upper and lower gums and contains molecules that react against HIV-specific antibodies produced by the body. Results are ready just 20 minutes later. Two lines on the dipstick signify a positive result, which must be confirmed by a more sensitive test at a clinical laboratory. The company plans to provide a 24-hour hotline so that customers can ask questions or receive counseling, but the phone call is optional.

FDA approval of OraQuick would probably pave the way for other in-home HIV tests. Chembio Diagnostic Systems, based just outside New York City, already plans to seek approval for a home version of its rapid 'Sure Check HIV' test, which requires a drop of blood. Although over-the-counter tests for HIV and hepatitis C are already available from Illinois-based Home Access Health Corporation, both require the consumer to send a blood specimen to a laboratory for analysis and results.

No test is perfect, however, and one major concern is that people who test negative using the OraQuick kit might actually have HIV. In a recent phase 3 trial, OraSure gave the prototype to 5,662 individuals to use in their homes. The results, made public by the company in filing for approval, indicate that only 93% of the 114 individuals infected with HIV received a positive test result. In the clinical setting, the same test is 99% accurate. Why the home test missed so many infections isn't clear. Because the OraQuick test detects HIV-specific antibodies, recently infected individuals may test negative. False positives seemed to be less of a problem; only one uninfected study participant tested positive.

Read the rest.

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position. Please look for us on Facebook here and you can follow us on Twitter @mappingpathways as well.]

No comments:

Post a Comment