Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus

In September 2016, the Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) published  a new Guidance for Industry "Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)". This document supersedes the draft guidance of the same title dated December 2015.
West Nile virus (WNV) is a mosquito-borne flavivirus that has become endemic in the United States. From 1999-2012, there have been 37088 reported cases of WNV and 1549 deaths, resulting in a 4.2% case-fatality rate. Related to the transmission, the WHO stated that, amongst the classic way from infected mosquitos, it can be transmitted through organ transplant, blood transfusions, Tissues and breast milk. There is one reported case of transplacental (mother-to-child) WNV transmission.

The current guidance provides establishments making donor eligibility (DE) determinations for donors of HCT/Ps with recommendations for testing living donors for West Nile Virus (WNV) using an FDA-licensed donor screening test. Activities in NAT testing of WNV started in 2002 with a workshop entitled “Development of Donor Screening Assays for West Nile Virus”, followed by guidance documents about donor eligibility and a first draft guidance on NAT testing in 2008. In 2013 we reported  about the Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Human Cells, Tissues, and Cellular and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).

In their new guidance document, the FDA stated: "We (FDA) believe that the use of an FDA-licensed nucleic acid test (NAT) will reduce the risk of transmission of WNV from living donors of HCT/Ps and therefore recommend that you use an FDA-licensed NAT to test living donors of HCT/Ps for evidence of infection with WNV as set forth in this guidance."

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

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