Does the FDA Guidance issued November 2011 allow for reenty of a donor who tested positive for HBsAg confirmed by neutralization in 2008, prior to implementation of the HBV-NAT? This donor gives documented evendence of receipt of the Hepatitis Vaccination 4 days prior to donation. All other testing was negative or non-reactive. On a sample drawn for reentry puposes the donor tests nonreactive for HBsAg, HBcAb and HBV RNA by NAT(<= 2IU Sensitivity). The Guidance document does not specifically address donors prior to implementation of HBV NAT. Would this donor qualify for reentry?
