国产化时间分辨免疫荧光法游离雌三醇检测试剂盒性能验证

Performance Verification of Domestically Produced Time-resolved Immu⁃nofluorescence Detection Kit for Free Estriol

目的对国产游离雌三醇定量检测试剂盒进行分析性能验证,判断该试剂盒是否能够满足医学实验室的临床检验要求。方法分析中孕期母血清游离雌三醇定量检测试剂盒的批内精密度、批间精密度、总精密度,正确度和线性范围,同时与试剂盒厂家声称的参数范围进行比对。结果在精密度验证中,低、中、高浓度检测样本的批内变异系数分别为4.72%、2.22%、2.25%;批间变异系数分别为2.76%、2.26%、3.33%;总精密度的变异系数分别为5.00%、3.00%、3.90%,均在厂家声称的标准上限范围之内。在正确度验证中作为验证样本的国家卫健委室间质评样本参考物质的均值分别为2.60、4.50、1.80、6.00、6.90 nmol/L均在验证区间之内。在线性范围验证中,配置覆盖整个标准曲线的6个浓度血清样本。以测量值为横坐标,理论值为纵坐标画出曲线,拟合曲线方程,得出相关系数r2=0.9954。根据行业标准>0.995可判断厂家声称的线性范围符合要求。结论本国产游离雌三醇定量检测试剂盒分析性能验证有效,可满足临床检验需求。

Objective To verify the analytical performance of the domestic free estriol quantitative detection kit,and to determine whether the kit can meet the clinical testing requirements of medical laboratories.Methods The intra assay precision,inter-assay precision,total precision,correctness and linear range of the kit for the quantitative detec⁃tion of free estriol in maternal serum in mid-pregnancy were analyzed,and compared with the parameter range claimed by the kit manufacturer.Results In the precision validation,the intra-assay coefficients of variation of samples with low,medium and high concentrations were 4.72%,2.22%,and 2.25%,respectively;the inter-assay coef⁃ficients of variation were 2.76%,2.26%,and 3.33%,respectively.The coefficients of variation of the overall precision were 5.00%,3.00%,and 3.90%,which were all within the upper limit of the standard stated by the manufacturer.The mean values of the reference materials of the National Health and Medical Commission inter-laboratory quality assess⁃ment samples used as the verification samples in the accuracy verification were 2.60 nmol/L,4.50 nmol/L,1.80 nmol/L,6.00 nmol/L,and 6.90 nmol/L,all within the verification range.In the linear range validation,six concentrations of serum samples were prepared covering the entire standard curve.Draw a curve with the measured value as the ab⁃scissa and the theoretical value as the ordinate,fit the curve equation,and get the correlation coefficient r2=0.9954.According to the industry standard greater than 0.995v0,it can be judged that the linear range claimed by the manu⁃facturer meets the requirements.Conclusion The analytical performance of the domestic free estriol quantitative de⁃tection kit is valid and can meet the needs of clinical testing.