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 more than 900 patient specimens where the products demonstrated a test sensitivity of 100 percent and a specificity of 99 percent in specific patient populations. HSV is a chronic disease that infects more than 1 billion people worldwide. HSV-1 is commonly associated with oral herpes and HSV-2 with genital herpes, although both have been shown to affect either area. According to the Centers for Disease Control and Prevention (CDC), 45 million people in the
Trinity Biotech believes that their HSV Type Specific ELISAs, allowing the differentiation between HSV-1 and 2, are an important diagnostic tool and will provide physicians with the information necessary to establish treatment options and initiate appropriate patient counseling. It is hoped that these tests will form part of the public health armory against the continually increasing HSV epidemic in the
Commenting on the FDA clearance, Ronan O'Caoimh, CEO said: "We are very pleased with the FDA's decision to clear our CAPTIATM HSV type specific ELISAs. This further strengthens our position in the
Trinity Biotech develops, acquires, manufactures and markets more than 500 diagnostic products for the point-of-care and clinical laboratory segments of the diagnostic market. The broad line of test kits are used to detect infectious diseases, sexually transmitted diseases, blood coagulation disorders, and autoimmune diseases.
Source: Trinity Biotech