Archived Actions:

2007

8/24/07
The Food and Drug Administration and Center for Medicare and Medicaid Services releases documents finalizing hepatitis C lookback requirements for hospital transfusion services, blood banks and blood centers.

2006

10/06
FDA approves a qualitative assay to screen for HCV RNA (as well as HIV-1 RNA) in plasma and serum specimens from individual human donors, including donors of whole blood and blood components, source plasma, and other living donors. Procleix Ultrio, manufactured by Gen-Probe, is an in-vitro nucleic acid assay system. Although the test also is designed to detect hepatitis B virus DNA, it is not yet approved by FDA for that purpose.

7/18/06
FDA approves the Abbott PRISM hepatitis B surface antigen (HbsAg) screening and confirmatory tests. These chemiluminescent tests are intended for use in screening individual human donors, including volunteer donors of whole blood and blood components, for the presence of HbsAg. The HbsAg confirmatory assay confirms the presence of HbsAg in human serum and plasma through specific antibody neutralization.