Nucleic acid testing guidance
This article was originally published in The Gray Sheet
Executive Summary
Blood banks should implement recommendations from FDA 1guidance on NAT in whole blood and blood components (including source plasma and source leukocytes) within six months of Oct. 28 publication in the Federal Register, the agency advises. Pertaining to nucleic acid tests for HIV-1 and hepatitis C virus, the document updates an April 2002 draft guidance, combining it with a December 2001 guidance on NAT testing in plasma. The consolidated guidance features recommendations for donor screening and reporting requirements for licensed blood and plasma establishments. The new document also addresses product labeling and disposition...