{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2023,10,2]],"date-time":"2023-10-02T05:50:42Z","timestamp":1696225842810},"reference-count":26,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2013,6,16]],"date-time":"2013-06-16T00:00:00Z","timestamp":1371340800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Vox Sanguinis"],"published-print":{"date-parts":[[2013,10]]},"abstract":"<jats:sec><jats:title>Background and Objectives<\/jats:title><jats:p>Evaluation of variant <jats:styled-content style=\"fixed-case\">C<\/jats:styled-content>reutzfeldt\u2013<jats:styled-content style=\"fixed-case\">J<\/jats:styled-content>akob disease (<jats:styled-content style=\"fixed-case\">vCJD<\/jats:styled-content>) diagnostic\/donor screening tests is made complicated by the very limited supply of blood samples from clinically confirmed cases of <jats:styled-content style=\"fixed-case\">vCJD<\/jats:styled-content>. To determine appropriate access for test developers to rare <jats:styled-content style=\"fixed-case\">C<\/jats:styled-content>reutzfeldt\u2013<jats:styled-content style=\"fixed-case\">J<\/jats:styled-content>akob disease (<jats:styled-content style=\"fixed-case\">CJD<\/jats:styled-content>) blood samples, the oversight committee of the <jats:styled-content style=\"fixed-case\">NIBSC CJD<\/jats:styled-content> Resource Centre has developed a process and protocols detailing minimum requirements for both test sensitivity and specificity. This protocol is broadly similar to that outlined in the common technical specification (European Directive 98\/79\/EC).<\/jats:p><\/jats:sec><jats:sec><jats:title>Materials and Methods<\/jats:title><jats:p>Tests are subjected to a stepwise evaluation (step 1). <jats:styled-content style=\"fixed-case\">vCJD<\/jats:styled-content> tissue homogenates spiked into pooled human plasma (step 2). Blood samples from animals known to be incubating (Transmissible spongiform encephalopathy) <jats:styled-content style=\"fixed-case\">TSE<\/jats:styled-content> disease (scrapie\/Bovine Spongiform encephalopathy (BSE)\u2010infected sheep, BSE\u2010infected primates) and appropriate controls (step 3). Fresh or frozen plasma from normal UK blood donors and (step 4). Plasma samples from individuals with confirmed clinical stage variant CJD (transfusion transmission) or sporadic CJD (no evidence of blood transmission).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The assay evaluated performed with good sensitivity with <jats:styled-content style=\"fixed-case\">vCJD<\/jats:styled-content>\u2010spiked tissue homogenates, poor sensitivity for ovine <jats:styled-content style=\"fixed-case\">TSE<\/jats:styled-content>\u2010infected blood samples and failed with plasma from <jats:styled-content style=\"fixed-case\">BSE<\/jats:styled-content>\u2010infected non\u2010human primates and with true <jats:styled-content style=\"fixed-case\">vCJD<\/jats:styled-content> clinical samples.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The test evaluated here is currently unsuitable for use in blood donor screening or diagnosis using blood.<\/jats:p><\/jats:sec>","DOI":"10.1111\/vox.12037","type":"journal-article","created":{"date-parts":[[2013,6,17]],"date-time":"2013-06-17T01:46:54Z","timestamp":1371433614000},"page":"196-204","source":"Crossref","is-referenced-by-count":8,"title":["Evaluation of a test for its suitability in the diagnosis of variant <scp>C<\/scp>reutzfeldt\u2013<scp>J<\/scp>akob disease"],"prefix":"10.1111","volume":"105","author":[{"given":"J. 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