FDA Publish Guidance on “lookback” for HepC in Donor Blood

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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. 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.”

This guidance document provides recommendations for complying with 21 CFR 610.47 and
21 CFR 610.481 to (1) blood establishments that collect blood or blood components, including Source Plasma and Source Leukocytes, (2) hospitals, and (3) other consignees. This guidance does not apply to autologous donations, pooled blood components intended solely for further manufacturing into products that are manufactured using validated viral clearance procedures, and blood and blood components that were intended for manufacture into non-injectable products subject to the labeling described in Section VI.

This document supersedes the guidance document of the same title, dated August 2007. The August 2007 document superseded the HCV sections of the Food and Drug Administration (FDA) memorandum of July 19, 1996, entitled “Recommendations for the Quarantine and Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening Tests for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), and Human T-Lymphotropic Virus Type I (HTLV-I).” The August 2007 guidance document also superseded the September 1998 guidance entitled “Guidance for Industry: Current Good Manufacturing Practice for Blood and Blood Components: (1) Quarantine and Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening Tests for Antibody to Hepatitis C Virus (Anti-HCV); (2) Supplemental Testing, and the Notification of Consignees and Blood Recipients of Donor Test Results for Anti-HCV.” Additionally, the August 2007 guidance finalized FDA’s draft guidance dated June 1999 entitled “Guidance for Industry: Current Good Manufacturing Practice for Blood and Blood Components: (1) Quarantine and Disposition of Prior Collections from Donors with Repeatedly Reactive Screening Tests for Hepatitis C Virus (HCV); (2) Supplemental Testing, and the Notification of Consignees and Transfusion Recipients of Donor Test Results for Antibody to HCV (Anti-HCV).”

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