单增李斯特氏菌SureTect实时PCR检测方法的 比较研究

Comparison study on SureTect real-time PCR test methods for Listeria monocytogenes

中文关键词:  单增李斯特氏菌  Sure Tect实时PCR检测方法  方法验证  方法比较研究

英文关键词:Listeria monocytogenes  SureTect real-time PCR analysis  validation of methods  methods comparison study

中文摘要:

      目的 评估食品中单增李斯特氏菌SureTect实时PCR检测方法的性能。方法 按照ISO 16140:2003/ Amd 1:2011《食品和动物饲料微生物学-可替代方法的验证方案》的要求对该方法进行了实验室内的方法比较研究(即实验室内的验证)。结果 对于不同的食品类别, 该方法的相对准确性在77%~85%之间, 相对特异性在72%~83%之间, 相对灵敏度在72%~91%之间, 相对检测限在0.02~0.06 CFU/g。统计检验表明, 该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, 两种方法的相对检测限也无显著性差异。使用50株目标菌株和30株非目标菌株进行方法选择性实验, 两种方法检测结果均一致。结论 单增李斯特氏菌SureTect实时PCR检测方法是一种快速、准确和灵敏的检测方法。

英文摘要:

      Objective In order to validate the SureTect real-time PCR test for Listeria monocytogenes in food. Methods Comparison study was conducted between the method and the reference method detailed in National Standard GB 4789.30 Microbiological examination of food Hygiene-Examination of Listeria monocytogenes according to ISO 16140:2003/Amd:2011 Microbiology of food and animal feeding stuffs-protocol for the validation of alternative method. Results For different food categories, the relative accuracy of the method was between 77% and 85%, the relative specificity was between 72% and 83%, and the relative sensitivity was between 72% and 91%. The relative detection level was between 0.02 CFU/g and 0.06 CFU/g. Statistical tests proved that there were no significant difference between the relative accuracy of two methods for relative specificity, relative sensitivity and relative detection level. As to the selectivity, fifty target strains and thirty non-target strains were tested by the two methods. The results of the strains were congruent by the SureTect real-time PCR test. Conclusion Results proved that the SureTect Listeria monocytogenes assay is a rapid, accurate, and sensitive detection method.