Industry News (Diagnostics)

U.S. FDA Approval Granted for HCV Test

Published in Blood Weekly, March 1st, 1999

Ortho-Clinical Diagnostics, Inc., Raritan, New Jersey, and Chiron Corp., Emeryville, California, announced that the U.S. Food and Drug Administration (FDA) has licensed their confirmatory test to detect the presence of hepatitis C virus (HCV) antibodies in human blood.

The Chiron Riba 3.0 Strip Immunoblot Assay (SIA), is intended as a supplemental test for human serum or plasma specimens found to be repeatedly reactive in HCV antibody screening procedures. It assists blood organizations in counseling donors whose blood specimen reacts positive to HCV antibody screening tests. Chiron Riba HCV 3.0 SIA also helps physicians confirm the initial diagnosis of hepatitis C...

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