GB 4789.40-2016和ISO 22964:2017方法检测婴幼儿配方奶粉中克罗诺杆菌属的实验室适用性研究

克罗诺杆菌属（原阪崎肠杆菌）可在婴幼儿配方粉（Powdered Infant Formula,PIF）中长期存活。随着食品贸易的全球化，人们对婴幼儿配方粉（PIF）中克罗诺杆菌的污染尤为关注。本文参照ISO 16140-2 2016中方法比对的原则要求，对检测PIF中克罗诺杆菌的中国标准方法 GB 4789.40-2016（参考方法）和欧盟标准方法 EN ISO 22964:2017（替代方法）进行了方法比较研究。共有12个外部实验室参与检测3个不同污染水平（0 MPN/10 g,1.299 MPN/10 g和2.210 PMN/10 g）下添加了测试菌株的576份盲样的测试。结果表明，在低污染水平和高污染水平下，GB 4789.40-2016的灵敏度分别为80.00%和81.16%，而ISO 22964:2017对应的灵敏度分别为90.00%和97.10%。无论污染程度如何，相对检测水平（RLODs）都低于接受限（AL=2.5）。同时，采用AOAC指南中提出的检测概率（POD）模型对统计数据进行了分析，结果显示替代方法和参考方法之间没有统计学上的显著差异。据此得出用于检测PIF中阪崎...

An Interlaboratory Method Applicability Study of GB 4789.40-2016 and ISO 22964:2017 for the Detection of Cronobacter spp. in Powdered Infant Formula

It is documented that Cronobacter spp. (formely Enterobacter sakazakii) can survive in powdered infant formula (PIF) for a long period, and special concerns have been raised about the safety of powdered infant formula (PIF) contaminated by Cronobacter spp. with the globalization of the food supply. This study compared the methods for detecting Cronobacter spp. in PIF of the Chinese standard method GB 4789.40-2016 (reference method) and the European standard method EN ISO 22964:2017 (alternative method) according to the principle requirements of method comparison in ISO 16140-2 2016. A total of 576 blind-coded test portions of the product spiked with the test strain at three different contamination levels (0 MPN/ 10 g, 1.299 MPN/10 g and 2.210 PMN/10 g) were analyzed by 12 participating laboratories. The results showed that the sensitivity of GB 4789.40-2016 was 80.00% at the low contamination level and 81.16% at the high level, while those of ISO 22964:2017 were 90.00% and 97.10%, respectively. The relative levels of detection (RLODs) were below the acceptance limit (AL=2.5) regardless of the contamination level, and the probability of detection (POD) model proposed in the AOAC guidelines was analyzed. Results revealed no statistically significant difference between the alternative and reference methods. It was concluded that the GB 4789.40-2016 method for the detection of C. sakazakii in PIF was equivalent to the ISO 22964:2017 method.