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# HCT/P Donor Eligibility Test Guidance
- URL: https://www.fdaweb.com/hct-p-donor-eligibility-test-guidance/
- Published: 2017-05-03T12:00:00.000Z
- Updated: 2026-09-14T22:21:24.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5138610

FDA has issued a guidance, *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)*, to provide agency recommendations for testing living donors for West Nile Virus using an FDA-licensed donor screening test. The [document](https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/UCM372084.pdf?ref=fdaweb.com) says the agency believes that using an FDA-licensed nucleic acid test will reduce the risk of transmission of West Nile Virus from living donors of HCT/Ps and thus recommends that those making donor eligibility determinations use such a test.

The guidance finalizes a 12/2015 draft and supplements donor screening recommendations in portions of an 8/2007 guidance.