6种铝快速检测试剂盒的质量评价

Quality evaluation of 6 kinds of rapid detection kits for aluminum

目的对市场上6种商品化比色法测食品中铝残留量快速检测试剂盒(以下简称铝快检试剂盒)进行质量评价;为食品安全监管中铝快检试剂盒的选择和使用提供参考依据。方法分别用铝快检试剂盒和GB5009.182-2017《食品安全国家标准食品中铝的测定》分光光度法对样品中的铝残留量进行测定,验证试剂盒检测的准确性,分析铝快检试剂盒的假阳性率、假阴性率、检出限、符合率,对其进行质量评价。结果试剂盒A、B、D符合率在95%以上,且假阴性率小于10%;试剂盒C、F假阴性率达50%左右;5种试剂盒的检出限与试剂盒标识不相符;试剂盒C、E检测结果不易判定;试剂盒A、B、F试剂装量不足,试剂盒C、F外包装与说明书贮藏条件不一致。结论快速检测试剂盒在使用前,有必要通过假阳性率、假阴性率、检出限、符合率等指标对试剂盒检测结果的可靠性验证。

Objective To conduct the quality evaluation of 6 kinds of commercially available colorimetric assay kits （hereinafter referred to as aluminum rapid test kit） in the market, and provide references for the selection and use of the aluminum rapid test kit for food safety supervision. Methads The aluminum residue in samples was determined by aluminum rapid test kit and GB 5009.182-2017 National food safety standard, Determination of aluminum in food-spectrophotometry. The accuracy of the kit was verified. The false positive rate and false negative rate, the detection limit and coincidence rate of the kit were analyzed, and the quality of the kit was evaluated. Results The coincidence rates of kit A, B and D were over 95%, and the false negative rates were less than 10%. The false negative rates of kit C and F were about 50%. The limits of detection of five kits were not consistent with their identification. Kit C and E test results were not easy to determine. The reagent amounts of kit A, B, and F were insufficient. The storage conditions of kit C and F were not consistent with the instructions. Conclusion It is necessary to verify the reliability before the use of the rapid detection kit by false positive rate, false negative rate,limit of detection and coincidence rate.