First Direct Test for Early Detection of Hepatitis C

A new in vitro diagnostic assay is the first test to be commercialized for the direct detection of HCV (hepatitis C) core antigen, a marker of early infection. The test, called Antibody to HCV Core Antigen, is an enzyme linked immunosorbent assay (ELISA).

The results of international field studies on the assay have shown a significant improvement over current immunoassay techniques in closing the HCV infectious window by 40-50 days. Data presented at the 1st Scientific Symposium on Technology for the Detection of Hepatitis C Virus Core Antigen, in Paris (France), showed that the new HCV assay detected HCV infection around 49 days earlier than existing HCV antibody assays.

The assay, from Ortho-Clinical Diagnostics, Inc. (Raritan, NJ, USA), is also the only direct detection test system available that provides results in less than three hours, is compatible with existing equipment, and is suited for large-scale screening of individual blood donors, says the company.

We have worked diligently to bring Ortho Antibody to HCV Core Antigen ELISA test system to market because of its potential to improve the safety of the world's blood supply, said Gerard Vaillant, group chairman, Ortho-Clinical Diagnostics. This assay has helped us continue the tradition of delivering breakthrough assays in the field of hepatitis.