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June 4, 2004 AABB PulsePoints ASSOCIATION BULLETIN #04-4
The West Nile virus (WNV) Task Force, which includes representatives from the national blood organizations, and liaison representative from the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), has continued to meet periodically to review issues relating to human WNV infection in the United States. Although the magnitude and geographic scope of WNV infection outbreaks in 2004 cannot be predicted with certainty, the CDC believes that it is reasonable to anticipate expansion of the virus into the Western states. In addition, the reappearance of WNV in previously affected areas remains a possibility, with human WNV activity peaking from July to September. Experience with individual donation nucleic acid amplification testing (ID-NAT) suggests that ID-NAT may identify infected units, not detectable through minipool nucleic acid amplification (MP-NAT). In 2003, six cases of WNV transmission not detected through MP-NAT were reported to CDC. On the basis of this information and projections about the course of the infection, most blood centers have developed triggers for the implementation of ID-NAT and plan to implement ID-NAT during limited periods of the epidemic season. It is difficult, if not impossible, to recommend a single trigger applicable in each location. In previous communications, the WNV Task Force has provided guidance on the development of statistically meaningful “triggers” for the initiation of ID-NAT in specific locations. The WNV Task Force has recommended that such triggers take into consideration both the frequency of positive MPs that contain individually reactive donations and the absolute number of WNV-reactive donations identified from MP testing within a predetermined geographic area. The WNV Task Force has also recommended that there be a well-defined, data-based process for cessation of ID-NAT. In recent weeks, a few organizations have indicated that they are contemplating or have decided to forego MP-NAT and implement ID-NAT without indicators that an outbreak is anticipated. The implementation of ID-NAT testing requires additional critical resources, including equipment, reagents and trained technologists, all of which will be in short supply or not available in every location in a timely manner if widespread implementation of ID-NAT is launched in many areas with little or no WNV activity. The WNV Task Force believes that immediate, full-scale implementation of ID-NAT in areas of the country without substantial human WNV could result in a lack of timely ID-NAT capability in areas with critical need due to epidemic activity. For this reason, the blood organization members of the WNV Task Force, AABB, America’s Blood Centers and the American Red Cross, recommend that blood establishments considering the implementation or further expansion of ID-NAT do so in conformance with pre-defined statistically meaningful triggers so that the finite resources for ID-NAT can be targeted in the blood community first in those areas with extensive outbreaks.
-- End of AABB PulsePoints -- |
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Posted June 4, 2004
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