Background: West Nile virus (WNV) can be transmitted by transfusion through infected blood components. In Germany, a 28-day deferral for blood donors of therapeutic blood components who had spent at least 2 days in WNV-endemic areas from June 1 to November 30, 2014 was enforced. Otherwise, screening of blood donors for WNV RNA or the application of pathogen reduction techniques are appropriate alternatives. Methods: In the present study, we evaluated NAT screening for the detection of WNV in blood components. A total of 58 minipools consisting of 357 individual blood donors were screened for the presence of WNV RNA employing an automated high-volume extraction method using the RealStar WNV RT-PCR Kit. Additionally, different WNV reference reagents were quantified to prove the status quo of standardization. Four different WNV real-time NAT kits were compared using samples of an external quality assessment panel. Results: The 95% lower detection limit of the WNV MP-NAT was determined to 30.2 copies/ml (95% CI 24.2-45.4 copies/ml). No WNV RNA-positive minipool was detected. Quantification of WNV reference reagents revealed shortcomings in standardization. Comparison of several WNV NAT assays showed considerable differences in assay sensitivities and particularly a missing detection of WNV lineage 2. Implementation of seasonal WNV MP-NAT screening was demonstrated. Conclusion: Actually, WNV infections in Germany are rare events introduced by returning travelers, but surveillance of these emerging infections is important for safety in blood supply. The validation study pointed out the need for standardization of WNV NAT because of current lack of an international standard for WNV RNA.

Keywords:
Blood donation testing, Blood safety, NAT screening, Quality control
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2015
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