Wednesday, May 11, 2016: 11:15 AM
Kokkali Room (Megaron Athens International Conference Center)
Reinhard Zeleny, European Commission, Joint Research Centre, Institute for Reference Materials and Measurements, B-2440 Geel, Belgium
Hĺkan Emteborg, European Commission, Joint Research Centre, Institute for Reference Materials and Measurements, B-2440 Geel, Belgium
Jean Charoud-Got, European Commission, Joint Research Centre, Institute for Reference Materials and Measurements, B-2440 Geel, Belgium
Heinz Schimmel, European Commission, Joint Research Centre, Institute for Reference Materials and Measurements, B-2440 Geel, Belgium
Isabelle Mutel, Université Paris-Est, ANSES, Laboratory for Food Safety, F-94700 Maisons-Alfort, France
Yacine Nia, Université Paris-Est, ANSES, Laboratory for Food Safety, F-94700 Maisons-Alfort, France
Frédéric Auvray, Université Paris-Est, ANSES, Laboratory for Food Safety, F-94700 Maisons-Alfort, France
Jacques-Antoine Hennekinne, Université Paris-Est, ANSES, Laboratory for Food Safety, F-94700 Maisons-Alfort, France
Introduction: Staphylococcal enterotoxins (SEs) released into food are causing a large number of food-borne illnesses in the EU and elsewhere (n=393; 2014). European legislation (Commission Regulation (EC) No 1441/2007) stipulates that, if the food is to be considered safe for human consumption, SEs must not be detected with the so-called European Screening method (ESM) in each of the five portions to be taken from a food sample. To enable laboratories to provide reliable and accurate results, certified reference materials (CRMs) are pivotal and should be used for method validation and method performance qualification purposes.
Purpose: To certify a set of three reference materials (blank, and two spiked materials with SEA at sub-ng/g cheese) to support laboratories in applying the ESM as regards to presence/absence testing of staphylococcal enterotoxins in cheese.
Methods: A laboratory intercomparison with 15 laboratories was conducted using the ESM with either the commercial VIDAS® SET2 or the RIDASCREEN® SET Total detection assay. For each material, each laboratory performed 9 independent analyses over 3 measurement days. The obtained data were technically and statistically scrutinized, and certified values were expressed as specificity (blank material) and sensitivity (SE-containing materials) as defined in ISO 16140.
Results: All accepted individual results were correct, i.e. no false positives and no false negative results were reported by the laboratories. The probability of correct classification of these materials was therefore 100%, and one-sided lower confidence limits were estimated assuming a Poisson distribution. In addition, the average value and the intervals of the obtained test values (VIDAS) and absorbance units (Ridascreen) are reported on the certificate.
Significance: The CRMs will support laboratories for the validation of the ESM and serve as QC samples to verify that the method is working correctly. In that respect, they support legislation and improve consumer protection.
