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More notes on Ultra-sensitive viral load testing

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  • claudine intexas
    http://www.natap.org/2001/aasld2/day10.htm AASLD ( American Association for the Study of Liver Diseases) November 9-13, 2001, Dallas HCV Viral Load
    Message 1 of 1 , Apr 29 9:18 PM
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      http://www.natap.org/2001/aasld2/day10.htm

      AASLD ( American Association for the Study of Liver
      Diseases)
      November 9-13, 2001, Dallas

      HCV Viral Load Ultrasensitive Testing

      Reported by Jules Levin

      After I sent out the report on the TMA ultrasensitive
      viral load test reported on here at AASLD, I received
      this note from LabCorp. I thought you would like to
      see it.

      The information (the TMA study I reported to you
      that was presented here at AASLD) compared a highly
      sensitive TMA qualitative test to LabCorp/NGI's highly
      sensitive quantitative test (apples/oranges) Our HCV
      quantitative test (HCV SuperQuant) has a sensitivity
      of 100 copies / 39 IU's w/ a dynamic range to 5
      million copies / 2 million IUs. Our HCV qualitative
      RNA test (HCV UltraQual) has a sensitivity of 5-8
      copies / 2 IU's. The UltraQual test is the most
      sensitive qualitative test commercially available in
      the world. I'm surprised this test was not compared to
      TMA since it to is an ultra sensitive qualitative
      test.

      In fact, on September 21st LabCorp's National Genetics
      Institute announced the FDA approval of the HCV and
      HIV UltraQual tests for use in the screening of source
      plasma. This is the same HCV UltraQual test that we
      offer diagnostically. Because this was FDA approved in
      the screening market it has been scrutinized heavily
      by the FDA and its claims and purpose have been
      upheld/endorsed.

      LabCorp purchased NGI last fall and we have been
      making these exquisite tests available to all
      clinicians. NGI has completed the clinical trial work
      for all HCV drugs w/ the exception of one using these
      highly sensitive qualitative and quantitative RNA
      tests. We also announced yesterday the availability of
      the most sensitive HCV RNA quantitative test (HCV
      QuantaSure) w/ a sensitivity of 5-8 copies / 2 IU's to
      5 million copies / 2 million IUs.


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