19 December 2014 6 238 Report

Can it be that the most authors and researchers have neglected and still do not follow the demands of the following ISO norms (with year of coming into effect): 15193 (2002); 15194 (2002); 15195 (2003); 17511 (2003); 18153 (2003) and especially: ISO/PDTS 25680.8: Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures? This European Standard was approved by CEN on 2 March 2004 as EN 14136. Why do most published papers in this area not perform the minimum performance test by taking part in an inter-laboratory trial with real samples and not with pure aqueous solutions without a possibly interfering matrix (e.g., in bio-sensing: enzyme-poisoning, denaturing reagents, proteases, drug-metabolites, etc.)?

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