The U.S. Food and Drug Administration (FDA) approved a biologics license application (BLA) on July 9 for Abbott's Alinity s chemiluminescent microparticle immunoassay for detecting antibodies to the hepatitis C virus in human serum and plasma specimens.
The BLA covers the use of hepatitis C virus-encoded antigens for screening individual donors, including volunteer donors, of whole blood and blood components and living donors for the presence of the hepatitis C virus.
The Alinity s is designed to screen blood and plasma more efficiently within a smaller space versus commercially available competitive systems, Abbott noted in a statement on July 11.
