【摘要】 通过实验室内确认和实验室间协同实验对商品化单增李斯特氏菌LAMP试剂盒进行适用性评价,选择具有代表性的5大类15个细类食品基质,对剂盒方法包括灵敏度、特异性、假阴性率、假阳性率、相对准确度、检出限、耐变性以及批间变异8项定性方法性能指标进行实验室内评估。并对10家实验室的协同实验结果进行评价。试剂盒检测结果与基准方法 GB 4789.30-2010《食品安全国家标准食品微生物学检验单核细胞增生李斯特氏菌检验》检测结果上无显著差异,能基本满足食品样品的检测要求,但蔬菜制品类的商品化核酸试剂盒法灵敏度仅为5%、假阴性率高达95%、相对准确率为68%,且与基准法检测阳性确证比在5%的置信区间内存在统计学差异,因此不适用于蔬菜制品的检测。10家实验室对3个接种水平样本的检测,特异性、灵敏度以及相对准确度均为100%,因此LAMP试剂盒检测法结果稳定可靠。更多还原

【Abstract】 Based on indoor technical parameters by validation and collaboration test. Choose five categories and 15 sub-types for Typical food matrix,indoor technical parameters include sensitivity,specificity,false negative rate and false positive rate relative accuracy,limit of detection(LOD),resistance to denaturation and batch variation. Synergy of 10 laboratory to evaluate the results of the experiment. Results showed that the kit was not significantly different from the national standard method in general,and could meet the requirements of food sample testing. However,the sensitivity just 5 %,false negative rate is as high as 95 %,the relative accuracy is 68 %,and there is statistical differences within the 5 % confidence interval for positive confirm ratio compared with reference methods.Thus the commercial kit was not suitable for detection in vegetable products. Specificity,sensitivity and the relative accuracy is all 100 % for Three level of sample detection of 10 laboratory. So the LAMP kit method is stable and reliable.更多还原