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FDA Approves New Rapid 10-Minute HIV Test
  FDA approved, on December 23, 2003, the Uni-Gold Recombigen(TM) HIV rapidHIV test, a single use rapid test for the detection of antibodies to HIV-1in plasma, serum and whole blood (venipuncture). It is the first device tobe FDA approved for use with all three sample types. Uni-Gold Recombigen HIVis intended for use in point of care settings as an aid in diagnosis ofinfection with HIV-1.
Use of Uni-Gold Recombigen HIV is restricted to clinical laboratoryprofessionals in facilities having an adequate quality assurance program.The test is not approved to screen donors of blood, plasma, cells ortissues, or for home use.
Uni-Gold Recombigen HIV provides results in 10 minutes. It was approved bythe FDA on the basis of clinical trial results demonstrating testsensitivity of 100% and specificity of over 99.7%.
Test subjects must receive the "Subject Information Leaflet" prior tospecimen collection, and appropriate counseling when test results areprovided.
Positive test results require confirmation. The test is suitable for use inappropriate multi-test algorithms designed for the statistical validation ofrapid HIV test results.
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.Product labeling will be available in the coming weeks at http://www.fda.gov/cber/products/testkits.htm
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