Alinity s Anti-HCV II assay
STN: 125759
Proper Name: Hepatitis C Virus (E coli, Recombinant) NS3 Helicase Antigens and Synthetic Core Peptide
Tradename: Alinity s Anti-HCV II assay
Manufacturer: Abbott GmbH
Indication:
- The Alinity s Anti-HCV II assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of antibodies to hepatitis C virus (HCV) in human serum and plasma specimens on the Alinity s System.
- The Alinity s Anti-HCV II 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.
- The assay is also intended for use in 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 (non-heart-beating) donors. It is not intended for use on cord blood specimens.
- This test is not intended for use as an aid in diagnosis of infection with HCV.
Product Information
Supporting Documents
- July 15, 2022 Approval Letter - Alinity s Anti-HCV II assay
- July 14, 2022 Summary Basis for Regulatory Action -Alinity s Anti-HCV II assay