【摘要】 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。更多还原

【Abstract】 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 pole-strength.The evaluation recommended by the EP12-A2 document is practical and effective.更多还原