Guidance for Industry: Lookback for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV, August 2007 and update December 2010

摘要

Multiple layers of safeguards, including donor screening and testing, are used to reduce the risk of transmitting infection through blood transfusion. However, a person may donate blood early in infection, during the period when the viral marker is not detectable by a screening test, but the infectious agent is present in the donors blood (the window period). For example, if an individual donates blood on a number of occasions and each donation tests nonreactive for antibody to HCV, but the donor returns and tests repeatedly reactive for antibody to HCV at a later date, prior collections from such a donor could be at increased risk for transmitting HCV. In addition, a recipient of a transfusion of blood or blood components collected during the window period from a donor who is now repeatedly reactive would not know that he or she might be at increased risk of infection with HCV through the transfusion, unless he or she is notified. Furthermore, untested collections from donors who later were found to be repeatedly reactive when tested for antibodies to HCV since 1990 (when antibody tests for HCV became available) might have been at increased risk for transmitting HCV due to a chronic infection in the donor. Chronic hepatitis due to HCV is a major health problem in the U.S. The infection is usually clinically silent until the liver is seriously damaged. As a result, infected people usually are unaware of their disease. Although transfusion-transmitted infections account for only a very small proportion of HCV infections, it is possible to identify and lookback at prior donations that might have been collected during the window period.