“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: Guidance for Industry

Issue Date: December 1, 2010
Issued by: Center for Biologics Evaluation and Research
Topic(s): Blood Products
Status: Final

“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: Guidance for Industry

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 donor’s 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.

Download the Guidance Document