Use of Nucleic Acid Tests

With this guidance, the FDA addresses blood establishments that collect Whole Blood and blood components for transfusion or for further manufacture, including recovered plasma, Source Plasma and Source Leukocytes. Purpose of this guidance is to make recommendations concerning the use of FDA-licensed nucleic acid tests (NAT) to screen blood donors for hepatitis B virus (HBV) deoxyribonucleic acid (DNA). It further comprises recommendations for product testing and disposition, donor management, methods for donor re-qualification and product labelling.

In addition, the authority mentions that they consider the use of an FDA-licensed HBV NAT to be necessary to reduce adequately and appropriately the risk of transmission of HBV. FDA-licensed HBV NAT can detect evidence of infection at an earlier stage than is possible using previously approved hepatitis B surface antigen (HBsAg) and antibody to hepatitis B core antigen (anti-HBc) tests. Therefore, they recommend the use of FDA-licensed HBV NAT, in accordance with the requirements under Title 21 Code of Federal Regulations, 610.40(a) and (b) (21 CFR 610.40(a) and (b)).

To find out more please see the "Guidance for Industry - Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of Whole Blood and Blood Components, including Source Plasma, to Reduce the Risk of Transmission of Hepatitis B Virus".

Go back

GMP Conferences by Topics