Issue Date: December 2, 1987
Issued by: Center for Biologics Evaluation and Research
Topic(s): Blood, Blood Products
Status: Final
Recommendations for the Management of Donor and Units that are Initially Reactive for Hepatitis B Surface Antigen (HBsAg)
These recommendations set forth a series of procedures by which an initially HBsAg reactive donor may be reevaluated by a blood establishment, providing that all other donor suitability requirements are met. The decision of whether an initially reactive donor is to be reevaluated is left to the blood establishment. Furthermore, a blood establishment may adopt more stringent procedures, provided they are. consistent with these recommendations. At each step in this procedure, the predominance of each test and the interpretation of results should be as specified, in the package insert for that kit.
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