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Diagnostics
U.S. FDA clearance given for herpes simplex virus assay
September 5th, 2004
Trinity Biotech plc (TRIB) announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market its Captia HSV IgG Type Specific ELISAs in the United States. These products are approved for the detection of IgG antibodies to HSV 1 and 2 in human serum and are among the first HSV-type-specific ELISAs to be FDA cleared. In the past HSV serological testing has been limited by the inability of assays to distinguish between antibodies to HSV-1 and HSV-2. The Captia HSV type specific ELISAs use recombinant glycoproteins gG-1 and gG-2, which are type specific for HSV-1 and HSV-2 antibodies respectively. These glycoproteins...
Source: Medical Letter on the CDC & FDA (2004-09-05)
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