HCV supplemental testing
This article was originally published in The Gray Sheet
Executive Summary
Chiron Corp. asks FDA to amend its guidelines for blood donor screening for the hepatitis C virus to state that only licensed supplemental tests should be used. The April 23 guidelines state that donors should be tested with supplemental assays, and specifically cite Chiron's RIBA HCV 2.0 and Abbott's Matrix HCV tests. FDA currently has licensed only the Chiron test, the company says.