5种神经元特异性烯醇化酶检测试剂盒准确性分析

目的： 对国内已上市的5种神经元特异性烯醇化酶检测试剂盒（NSE试剂盒）检测样本的准确性进行评价。 方法： 分别制备20 ng·mL^-1和100 ng·mL^-1 2个浓度的NSE样品，选择方法原理为时间分辨免疫荧光法（TRFIA）、电化学发光免疫法（ECLI）、化学发光免疫法（CLIA）、酶联免疫法（ELISA）等5种NSE试剂盒分别对上述样品进行测定，并对线性、最低检出限、批内精密度、批间精密度和准确性进行分析。 结果： 5种试剂盒剂量曲线线性、最低检出限和精密度均能满足检测要求，但是准确性指标偏差较大，尤其是低浓度样品的准确性，不同试剂盒对同一样本的检测结果有显著性差异（P<0.01）。 结论： 行业标准和标准品的缺失给体外诊断试剂产品的市场监管带来困难，应建立NSE国家标准品，并制定产品的质量标准，从而较好的控制试剂盒的准确性，使不同试剂盒的检测结果具有较好的可比性。

Objective: To evaluate the accuracy of five kinds of neuron specific enolase(NSE)detection kits already on the market in China. Methods: NSE samples of two different concentrations,20 ng·mL^-1 and 100 ng·mL^-1,were prepared and subsequently detected with five kinds of kits,which included different principle of methods such as enzyme-linked immunosorbent assay(ELISA),chemiluminescent immunoassay(CLIA),electro-chemiluminescence immunoassay(ECLI)and time-resolved fluoroimmunoassay(TRFIA).The characteristics of linearity,lowest detectable limit,within-run precision,between-lot precision and accuracy were then assessed for each detection kit. Results: Lowest detectable limit and precision for the five kinds of kits could meet the detection requirements,however,the deviation of accuracy measurement was high,especially for samples of low concentrations.The results for the same kit detected by different kits had significant differences(P<0.01). Conclusion: The lack of industry standards and standard substances makes it difficult to perform supervision on the market of the in vitro diagnostic reagents.Therefore,the national standard substance of NSE and quality standard of the product should be established to control the accuracy of NSE kits,so that the data of different kinds of kits have a better comparability .