多厂家商品化黄曲霉毒素M1检测试剂盒质量评价与分析

目的对市场上11个厂家商品化黄曲霉毒素M_1快速检测试剂盒进行质量评价。方法定性检测试剂盒验证其灵敏度、特异性、假阳性率、假阴性率、符合率;定量试剂盒验证其范围和线性、准确度、精密度,并与实验室参考方法比较,分别对定性、定量试剂盒进行质量评价。结果 9个厂家定性试剂盒灵敏度、特异性及符合率均为100%,假阳性率及假阴性率均为0;厂家编号10的定量试剂盒准确度和精密度较差,厂家编号11的定量试剂盒线性、准确度及精密度较好,可以满足检测需求。结论黄曲霉毒素M_1快速检测试剂盒在定性检测方面较成熟,能够参与市场监督;定量试剂盒产品不够成熟,使用前应严格验证其指标。

Evaluation and analysis of factories commercial aflatoxin M1 rapid detection kits

Objective To evaluate the quality of 11 factories commercial aflatoxin M1 rapid detection kits on the market. Methods The qualitative detection kits were validated by sensitivity, specificity, false positive rate, false negative rate and compliance rate, and the quantitative detection kits were validated by range, linearity, accuracy and precision. Comparing the detection method with the laboratory reference method, the qualitive detection kits and the qualitative detection kits were evaluated respectively. Results The sensitivities, specificities and coincidence rates of 9 factories qualitative detection kits were all 100%, meanwhile the false positive rates and the false egative rates were 0. The accuracy and precision of No.10 factory quantitative detection kit were poor. The linearity, accuracy and precision of No.11 factory quantitative detection kit were better, meeting the detection needs. Conclusion The qualitative detection of aflatoxin M1 is mature, which can be applied in the market supervision. However, the quantitative detection is not mature enough and should be validated strictly before use.