FDA Approves New Anti-HCV Donor Screening Assay

July 19, 2022

The Food and Drug Administration approved a new anti-hepatitis C virus (HCV) donor screening assay on Friday. The Hepatitis C Virus (E coli, Recombinant) NS3 Helicase Antigens and Synthetic Core Peptide (Abbott Laboratories) is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of antibodies to HCV in human serum and plasma specimens on the Alinity s System.

The assay is intended to screen individual human donors, including volunteer donors of whole blood and blood components, and other living donors for the presence of anti-HCV. It is also intended for testing serum and plasma specimens to screen organ donors when specimens are obtained while the donor's heart is still beating, and in testing serum and EDTA plasma specimens to screen cadaveric donors. It is not intended for use on cord blood specimens.