Comments for NAT testing for West Nile Virus Guidance Document due to AATB by Jan. 8

10/30/2013

The FDA released a draft guidance document that describes nucleic acid testing for West Nile virus that's applicable to donors of human cells, tissues and cellular and tissue-based products (HCT/Ps). The document can be downloaded. This draft guidance document recommends: (1) year-round WNV testing by ID-NAT using a licensed NAT donor screening test; and (2) any donor whose specimen tests positive (or reactive) be considered ineligible. As noted above, the document is a draft, and the FDA is inviting comments. The AATB will collect and submit comments from membership. To be included in the AATB response, send comments to Scott Brubaker by Wednesday, Jan. 8.

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