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Bulletin #13-16 October 25, 2013

FDA Issues Draft Guidance on Nucleic Acid Testing (NAT) for

West Nile Virus (WNV)



Yesterday, the Food and Drug Administration (FDA) released a Draft Guidance document that describes Nucleic Acid Testing (NAT) for West Nile Virus (WNV) that's applicable to donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps). The document can be downloaded at the following website:


Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)


This draft guidance document recommends: (1) year-round WNV testing by ID-NAT using a licensed NAT donor screening test; and (2) any donor whose specimen tests positive (or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As noted above, the document is "draft guidance," and the FDA is inviting comments. The methods for submitting comments are included in the Notice published in the Federal Register. Refer to Docket No. FDA-2013-D-1143.


The deadline for filing comments is January 22, 2014. The AATB plans to collect and submit comments from our membership. Send yours to the attention of Scott Brubaker no later than Wednesday, January 8, 2014.







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The American Association of Tissue Banks (AATB) -- a professional, non-profit, scientific and educational organization -- is the only national tissue banking organization in the United States. Founded in 1976, the AATB is dedicated to improving and saving lives by promoting and advancing the safety, quality and availability of donated human tissue. To fullfill that mission, the AATB publishes standards and accredits tissue banks, certifies personnel and operates a tissue network.