Hepatitis is inflammation of the liver that can be caused by different toxins, immunologic processes or infectious agents, including viruses. According to the CDC, the most common types of the disease are hepatitis A, hepatitis B and hepatitis C, each caused by a virus of the same name. While viral hepatitis can be spread in different ways, all forms have the potential to be transmitted through blood transfusions. Implementation of improved tests and stringent screening criteria for donors has helped dramatically reduce the risk of transfusion or transplantation transmission of the virus in the United States.
On behalf of the transfusion medicine and cellular therapies community, AABB works with the FDA and other government agencies, either directly or through government advisory committees, as part of ongoing, collaborative efforts to protect against the transmission of hepatitis through blood and human cells, tissue, and cellular- and tissue-based products. In addition, AABB provides guidance to establishments while working with public health officials to monitor infection outbreaks.
AABB, America’s Blood Centers and the American Red Cross submitted
joint comments to FDA in response to the agency’s September 2018 draft guidance, “Further Testing of Donations that are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus.”
The FDA has published a new guidance entitled “Requalification of Donors Previously Deferred for a History of Viral Hepatitis after the 11th Birthday”. Donor Centers may follow the approved algorithm to requalify donors with a history of Hepatitis A, Cytomegalovirus and Epstein-Barr virus.
The FDA has announced the availability of the October 2012 "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" in a Nov. 15 "Federal Register"
notice. The guidance provides recommendations for the use of FDA-licensed NATs to screen blood donors for HBV DNA and for product testing and disposition, donor management, methods for donor requalification, and product labeling. The recommendations contained in the guidance document should be implemented within six months of the Nov. 15 publication.
FDA releases a guidance that provides recommendations to blood and plasma establishments, manufacturers, and testing laboratories for testing individual or pooled samples from donations of blood and blood components for HIV-1 RNA and HCV RNA.
FDA releases a guidance that provides recommendations to establishments that collect whole blood or blood components intended for transfusion for requalifying or re-entering deferred donors into the donor pool based on a determination that previous tests that were repeatedly reactive for antibodies to hepatitis B core antigen were falsely positive and that there is no evidence of infection with HBV.