National Center for Immunobiologicals Research and Evaluation

Rome, Italy

National Center for Immunobiologicals Research and Evaluation

Rome, Italy
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Dreier J.,Ruhr University Bochum | Vollmer T.,Ruhr University Bochum | Hinse D.,Ruhr University Bochum | Heuser E.J.,Ruhr University Bochum | And 2 more authors.
Transfusion Medicine and Hemotherapy | Year: 2016

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. © 2015 S. Karger GmbH.


PubMed | National Center for Immunobiologicals Research and Evaluation
Type: Clinical Trial | Journal: Blood transfusion = Trasfusione del sangue | Year: 2012

A second Italian external quality assessment programme was run in 2011 to assess the performance of blood transfusion centres in detecting West Nile virus RNA in plasma.Each participant received two panels containing negative samples and samples positive for West Nile virus lineages 1 and 2, some of which with a viral concentration close to or below the 95% limit of detection of the respective commercial nucleic acid amplification test assay: the PROCLEIX WNV assay or the Cobas TaqScreen West Nile virus test.Eleven laboratories took part in the external quality assessment programme. All of them correctly identified the positive samples with a viral concentration above the 95% limit of detection. No false positive results or pre-/post-analytical errors were observed.The External quality assessment programme run in 2011 allowed participants to assess the performance of the nucleic acid amplification test methods applied in their seasonal routine screening of blood donations. The results confirm the 95% limit of detection reported by the test kits manufacturers for both West Nile virus lineages.


PubMed | National Center for Immunobiologicals Research and Evaluation
Type: Journal Article | Journal: Blood transfusion = Trasfusione del sangue | Year: 2011

An Italian interlaboratory study was run in 2010 to assess the performance of Blood Transfusion Services in detecting the genome of West Nile virus (WNV) in plasma.Each laboratory received a panel of samples containing four samples negative for WNV and six positive samples with a nominal viral concentration close to or below the 95% detection limit of two commercially available nucleic acid amplification tests (NAT) for WNV, the PROCLEIX WNV kit and the Cobas TaqScreen West Nile Virus kit.Ten laboratories took part in the study. All correctly identified the positive samples with a viral concentration above the 95% detection limit. No pre- or post-analytical errors were observed.The interlaboratory study run in 2010 allowed participants to assess the performance of the NAT methods applied in their seasonal routine screening of blood donations.

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