FDA List Serve -FDA Approval of New, 10 Minute Rapid HIV Test
- You are receiving this message as a subscriber to the FDA HIV/AIDS electronic list serve. The purpose of the list serve is to relay important information about HIV/AIDS-related products and issues, including product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings and alerts to proposed regulatory guidances for comment.Please do not respond to this message._______________________________________________FDA approved, on December 23, 2003, the Uni-Gold Recombigen(TM) HIV rapid HIV test, a single use rapid test for the detection of antibodies to HIV-1 in plasma, serum and whole blood (venipuncture). It is the first device to be FDA approved for use with all three sample types. Uni-Gold Recombigen HIV is intended for use in point of care settings as an aid in diagnosis of infection with HIV-1.
Use of Uni-Gold Recombigen HIV is restricted to clinical laboratory professionals in facilities having an adequate quality assurance program. The test is not approved to screen donors of blood, plasma, cells or tissues, or for home use.
Uni-Gold Recombigen HIV provides results in 10 minutes. It was approved by the FDA on the basis of clinical trial results demonstrating test sensitivity of 100% and specificity of over 99.7%.
Test subjects must receive the "Subject Information Leaflet" prior to specimen collection, and appropriate counseling when test results are provided.
Positive test results require confirmation. The test is suitable for use in appropriate multi-test algorithms designed for the statistical validation of rapid HIV test results.
Product labeling will be available in the coming weeks at http://www.fda.gov/cber/products/testkits.htmThe Uni-Gold Recombigen HIV test is made by Trinity Biotech plc of Bray, Ireland, and distributed in the U.S. by Trinity Biotech USA, Jamestown, NY.
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