TestingSourcePlasmaforHepatitisBVirusbyNucleicAcid.pptVIP

Presentation Outline Issue Background Potential Benefits Product Safety Public Health Questions for the Committee BPAC Issue April 2011 FDA seeks advice from the Committee on whether scientific data support the concept that testing Source Plasma for hepatitis B virus (HBV) DNA by nucleic acid testing (NAT) increases the margin of safety of plasma derivatives and whether such testing in donors adds to public health. BPAC Issue April 2009 FDA sought advice from the Committee on issues related to Whole Blood donor screening for HBV DNA by HBV NAT to prevent transfusion transmission of HBV. The