基于 EP12-A2文件评价尿蛋白定性检测性能

Evaluate the Performance of Urine Protein Qualitative Test by EP12-A2 Document

目的：评价 AX-4030与 Cobas U411尿干化学分析仪在尿蛋白定性检测的分析性能，探讨定性试验性能评价方法。方法参照美国临床实验室标准化协会（CLSI）EP12-A2文件推荐方法，对日本京都 AX-4030和罗氏 Cobas U411尿干化学分析仪两检测系统尿蛋白定性检测做偏倚和不精密度分析，比较两检测系统的 C50，C5～C95区间以及不精密度区间。两系统同时检测310份临床尿标本蛋白，统计分析与评价两者结果的一致程度。结果尿干化学分析仪 AX-4030检测系统检测尿蛋白的 C50小于 CobasU411系统，AX-4030系统的 C5～C95区间比 U411系统的窄，AX-4030系统的不精密度曲线较 U411系统曲线陡峭；两套系统检测临床标本尿蛋白结果方法学的比较，一致性百分率为96.8％，阳性一致率为82.7％，阴性一致率为99.6％；95％CI 为94.2％～98.16％，Kappa 值为0.88。结论AX-4030检测系统在尿蛋白 C50临界值处的灵敏度及不精密度较 Cobas U411系统稍优，二者在临床标本检测中的尿蛋白结果一致性程度极强。EP12-A2推荐的定性试验性能评价方法可行、有效。

Objective To evaluate the analysis capability of urine protein qualitative test between AX-4030 and Cobas U411 urine dry chemistry analyzer,and study on evaluating the performance of qualitative test.Methods According to Clinical and Laboratory Standards Institute（CLSI）EP12-A2 document,analyzed the bias and imprecision of urineprotein qualitative test between the Aution MAX AX-4030 and Roche CobasU411 system.Their C50 ,C5 -C95 intervals and imprecision curves were compared.The protein of 310 specimens were simultaneously determined by both Cobas U411 and AX-4030,in order to evaluate their concordance.Results C50 for AX-4030 system was less than that for Cobas U411;C5 -C95 interval of AX-4030 system was narrower than CobasU411.The imprecision curve of AX-4030 system was steeper than Cobas U411.The comparison of the two analysis systems showed that the concordance was 96.8%,the positive concordance was 82.7%,and the negative concordance was 99.6%.The 95% credibility interval （CI）was 94.2%-98.16% and the Kappa value was 0.88. Conclusion For the sensitivity and imprecision of urine protein test in the C50 critical value,the AX-4030 system was better than Cobas U411.The concordance of them in determining clinical specimens was polestrength.The evaluation recommended by the EP12-A2 document is practical and effective.