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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.htm.
The 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.
Richard Klein
Office of Special Health Issues
Food and Drug Administration
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