FDA Clearance for CAPTIA™ Herpes Simplex Virus (HSV) IgG Type Specific ELISAs

Trinity Biotech plc have announced it has received clearance from the FDA to market its CAPTIA™ HSV IgG Type Specific ELISAs in the USA.

These products are approved for the detection of IgG antibodies to HSV 1 & 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 accurately differentiate between antibodies to HSV-1 and HSV-2 and considerably decrease or eliminate any potential cross reactivity.

CAPTIA™ HSV type specific ELISAs were cleared by the FDA on the basis of clinical trial results on over 900 patient specimens where the products demonstrated a test sensitivity of 100% and a specificity of 99% in specific patient populations.