欧洲标准局 参考物质 应用说明 IRMM Application Note 352_english.pdfVIP

Application Note November 2008 IRMM-352 Author: Liesbet de Baets European Commission - Joint Research Centre Institute for Reference Materials and Measurements (IRMM) Retieseweg 111, 2440 Geel, Belgium Email: jrc-irmm-info@ec.europa.eu 1. Presence / absence test For application in presence/absence tests, analyse at least two vials of the CRM. Plate and incubate material spheres as explained on the certificate under instructions for use. Count colony forming units (cfu) per plate and evaluate results based on individual cfu values per analysed vial. The test has been passed if, for each material sphere, the result is within the 95% confidence interval specified for the CRM (5 +- 2 on nutrient agar and 4 ± 2 on XLD agar). The test failed if the obtained cfu values are not within these limits. 2. Method validation If this CRM is used for method validation or testing of media, a similar approach as for certification of the batch should be applied. This requires the measurement of an appropriate number of CRM vials, minimum 15 in agreement with the number o