Call for Development of Blood Donor Screening and Supplemental Tests for Infections with West Nile Virus (WNV) 10/3/2002 Investigations of the ongoing U.S. epidemic of human infections with WNV have strongly suggested that WNV can be transmitted through blood transfusions, although the level of risk remains under study. Since about 80 percent of infected persons remain asymptomatic even when they are transiently viremic, screening of blood and plasma donors with laboratory tests for WNV likely will be necessary to protect blood safety if the epidemic persists. Currently there are no FDA approved tests available for donor screening or clinical diagnosis for WNV. The Food and Drug Administration, Center for Biologic Evaluation and Research, Office of Blood Research and Review, is interested in facilitating the development of commercial tests for detection of acute infection with WNV in blood and plasma donors and potentially for tissue and organ donors, including the development of supplemental tests. Towards that end, FDA encourages all interested parties, including candidate test kit manufacturers to contact FDA to discuss the potential for development of suitable tests for WNV nucleic acids, antigens, or antibodies. Additionally, FDA, in cooperation with other Public Health Service Agencies, plans to sponsor a public scientific meeting on November 4-5, 2002 in Bethesda, MD, to further discuss development of donor screening tests for WNV. The potential for use of pathogen removal or inactivation methods to reduce the risk of WNV from blood transfusions also will be discussed. For more information, please contact Sayah Nedjar, Ph.D., Branch Chief, Regulatory Project Management Branch, Division of Blood Applications, at 301-827-3524. In the interim FDA has posted information about WNV and blood safety provisions at http:/www.fda.gov/cber/safety/westnile.htm. Back to West Nile Virus Last Updated: 10/3/2002