Guidance for Industry Requalification Method for Reentry of Donors Who Test Hepatitis B Surface Antigen (HBsAg) Positive Following a Recent Vaccination against Hepatitis B Virus Infection.

摘要

This guidance document is intended for blood establishments that manufacture Whole Blood and blood components for transfusion or for further manufacture, including Source Plasma and Source Leucocytes. This guidance provides recommendations for a requalification method or process for the reentry of deferred donors who test repeatedly reactive for hepatitis B surface antigen (HBsAg), confirmed positive by neutralization, following a recent vaccination against hepatitis B virus (HBV) infection, and who are not infected by HBV.