NAT Testing of West Nile Virus from Human Cells and Tissues

On 24 October, the FDA published a Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Human Cells, Tissues, and Cellular and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In April 2008 the FDA published a draft guidance entitled “Guidance for Industry:  Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion and Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)” (April 28, 2008, 73 FR 22958) The following year, the authority finalized the recommendations for donations of Whole Blood and blood components in the guidance entitled “Guidance for Industry:  Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion”.  In the notice of availability announcing the finalized guidance, the FDA stated that they "were continuing to review public comments submitted on our recommendations for testing HCT/P donor specimens for WNV.  In the notice, we also expressed our intention to seek additional public input and to issue guidance for testing HCT/P donor specimens for WNV in the future".

With that draft the FDA now provides establishments making donor eligibility determinations for donors of HCT/Ps with recommendations for donor testing for West Nile Virus (WNV) using an FDA-licensed donor screening test. It is supposed to give information and recommendations regarding NAT testing of HCT/P donors for WNV.  It replaces the draft guidance entitled “Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion and Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)”. The testing recommendations in this guidance, when finalized, will supplement the donor screening recommendations for WNV (which will remain in place) that were made in the guidance entitled “Guidance for Industry:  Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)” in section IV.E. recommendations 15 and 16, section IV. F. recommendation 5, and Appendix 6 (and supersede the discussion of testing in Appendix 6).

The complete draft can be found here.