RapidChek检测食品中单增李斯特菌的方法评价

Evaluation of RapidChek method for detection of Listeria monocytogenes in food

目的评价RapidChek法检测食品中单增李斯特菌的检测效果并验证。方法采用t检验,比较RapidChek方法与GB 4789.30-2016方法的培养基增菌效果。依据ISO 16140:2003《食品和动物饲料微生物学-可替代方法的验证方案》,比较RapidChek检测方法与GB 4789.30-2016检测方法的检测效果,涉及的性能指标有相对准确性、相对特异性和相对灵敏度、包含性和排他性。结果 RapidChek检测方法增菌培养基效果优于GB 4789.30-2016方法增菌培养基LB_1。根据RapidChek检测方法、GB 4789.30-2016培养基+RapidChek试纸条方法、RapidChek培养基+GB 4789.30分离鉴定方法的统计检验得出,3种方法与参照方法在相对准确性、相对特异性和相对灵敏度方面无显著性差异。在包含性和排他性方面,RapidChek检测方法与GB 4789.30-2016检测方法的检测结果均一致。结论在所验证的指标上,RapidChek检测方法(包括与GB4789.30-2016组合的方法)与GB 4789.30-2016方法无差异。

Objective To evaluate and validate the performance of the RapidChek method for detection Listeria monocytogenes in foods. Methods Based on t-test, the effect of enrichment medium between the RapidChek method and the national standard GB 4789.30-2016 was compared. According to ISO 16140：2003/Amd：2011 Microbiology of food and animal feeding stuffs-protocol for the validation of alternative method, the detection effect of the RapidChek test method and the reference method detailed in GB 4789.30-2016 Microbiological examination of food Hygiene-Examination of Listeria monocytogenes was compared, with the performance indicators including relative accuracy, relative specificity, relative sensitivity, inclusivity and exclusivity. Results The effect of culture medium in RapidChek detection method was better than that of GB 4789.30-2016 enrichment medium LB_1. Three methods were studied, including RapidChek method, GB 4789.30-2016 enriching and RapidChek strip method, RapidChek enriching and GB 4789.30-2016 isolation and identification method. Statistical testing proved that there were no significant difference among the relative accuracy, relative specificity and relative sensitivity. As to the inclusivity and exclusivity, the results of the RapidChek method and the GB 4789.30-2016 were congruent. Conclusion For the performance of validation, there are no significant difference between the RapidChek method（including the methods combining with GB 4789.30-2016） and the GB 4789.30-2016.