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Feasibility study of a screening assay that identifies the abnormal prion protein PrP TSE in plasma: initial results with 20,000 samples
Author(s) -
Guntz Philippe,
Walter Christine,
Schosseler Patricia,
Morel Pascal,
Coste Joliette,
Cazenave JeanPierre
Publication year - 2010
Publication title -
transfusion
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.045
H-Index - 132
eISSN - 1537-2995
pISSN - 0041-1132
DOI - 10.1111/j.1537-2995.2009.02569.x
Subject(s) - asymptomatic , medicine , blood donations , blood transfusion , virology , multiplex , false positive paradox , whole blood , prion protein , epidemiology , disease , immunology , biology , bioinformatics , machine learning , computer science
BACKGROUND: It is likely that transmission of variant Creutzfeldt‐Jakob disease (vCJD) occurs by transfusion and that the candidate infectious agent (PrP TSE ) is present in small concentrations in the blood of infected donors in the asymptomatic phase of the disease. A new blood screening assay has been developed to detect PrP TSE in citrated plasma samples. STUDY DESIGN AND METHODS: Three regional Blood Transfusion Establishments (ETS) in France (ETS Alsace, ETS Bourgogne Franche‐Comté, and ETS Pyrénées‐Méditerranée) will screen 60,000 plasma samples (20,000 in each ETS) over a time period of approximately 9 to 12 months. RESULTS: Results provided in this report are those of the first testing site in Strasbourg, Alsace. The preliminary results have demonstrated an initial specificity of 97.60%. Upon repeat testing the specificity rate achieved 99.90% (20 repeat‐positive samples). Based on the known epidemiology of vCJD in France, it is likely that the repeat‐reactive samples are not true‐positives. CONCLUSION: The screening assay was studied in terms of specificity and practicality and was found to be suitable for use in routine testing of blood donations. However, throughput must be enhanced by automation of the assay, and traceability would be improved if automated systems were used to distribute and identify samples.