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FDA Approves 10-Minute HIV Test

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  • S. Alex Williams
    ***FDA Approves 10-Minute HIV Test*** The Food and Drug Administration (FDA) has approved the Uni-Gold Recombigen HIV test, developed by Trinity Biotech. It is
    Message 1 of 1 , Feb 10, 2004
      FDA Approves 10-Minute HIV Test
      ***FDA Approves 10-Minute HIV Test***


      The Food and Drug Administration (FDA) has approved the Uni-Gold Recombigen HIV test, developed by Trinity Biotech. It is the first rapid HIV test approved for testing blood serum, plasma and whole blood. In trials, the test detected 100 percent of HIV-positive specimens and was 99.7 percent accurate on negative samples. An estimated one-third of those with HIV do not know their HIV status. Use of rapid HIV tests is expected to help outreach programs identify HIV-infected individuals and link them to care for their HIV disease.


      In the U.S., Trinity plans to market the Uni-Gold test to hospitals, physicians and government programs for testing of health care workers and others who may experience occupational exposure to HIV. In addition, the test will be marketed for use with pregnant women to reduce the risk of mother-to-child transmission and to community-based prevention programs. Uni-gold has been approved for use in the World Health Oraganization's HIV testing program in Africa, and is also sold in Asia. The test will sell for $10.


      Source: HAB Information E-mail/Janaury 8


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