GMHC Supports FDA's Recommendation on Approval of In-Home HIV Test
May 16, 2012 - 2:48:06 PM
(HealthNewsDigest.com) - New York, NY--Today, the U.S. Food and Drug Administration's Blood Products Advisory Committee unanimously recommended approval of the first ever in-home rapid HIV test. The product--the OraQuick In-Home HIV Test--is manufactured by OraSure Technologies, Inc. GMHC's Testing Center has been using the OraQuick Rapid Test, which is the same device, for the past five years. The ease of use and accuracy of the test has been encouraging. In fact, over a 22-month period, GMHC performed 6,199 tests with the OraQuick kits with only .03% (2) false positives.
"No tool is right for every situation. Yet the OraQuick In-Home HIV Test would be another important tool in the HIV prevention arsenal and would increase testing in hard-to-reach groups," said Janet Weinberg, Chief Operating Officer of GMHC, who provided testimony at the FDA hearing.
Access to counseling that utilizes a harm reduction model, prevention education material and information on where to obtain confirmatory tests, should be included with the tests. A toll-free 24 hour/7 day a week telephone number staffed by qualified counselors (available in both English and Spanish, and with translators for additional languages) would also need to be provided, and include referrals to medical and emotional evaluation assistance. The test kits must clearly communicate the importance of reading the informational materials and calling the toll-free number for pre- and post-test counseling before and after conducting the test.
GMHC recognizes that the OraQuick Resource Center was established to provide 24/7/365 support via a toll-free number and was designed by the same organization that developed and manages the CDC referral and information network. It also includes a dynamic and interactive website.
Public health agencies should conduct a public education campaign regarding the basic operation and interpretation of home-use test results. Links to instructional videos and websites would be helpful (with the URL address provided on the test kit packaging - in both English and Spanish). Consideration should be given to using pictorial representations to describe appropriate test-kit use for those with limited reading skills.
Public health agencies will likewise need to address how home-use HIV test will impact HIV case reporting and HIV surveillance data. Consideration should be given to implementing an optional internet-based reporting system, including partner notification mechanisms, in conjunction with the test kits.
"We are confident that the OraQuick In-Home HIV Test is easy for the general public to use and interpret the results, while offering proper information on how to do confirmatory tests for initial positive tests," added Weinberg. "This could be a powerful tool in combating the spread of HIV."
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GMHC is a not-for-profit, volunteer-supported and community-based organization committed to national leadership in the fight against AIDS. We provide prevention and care services to men, women and families that are living with, or affected by, HIV/AIDS in New York City. We advocate for scientific, evidence-based public health solutions for hundreds of thousands worldwide. For more information, please visit www.gmhc.org.
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