Evaluate the Performance of Urine Protein Qualitative Test by EP12-A2 Document / 现代检验医学杂志

ABSTRACT

Objective To evaluate the analysis capability of urine protein qualitative test between AX-4030 and Cobas U411 u-rine 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 eval-uate 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 com-parison 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 recommen-ded by the EP12-A2 document is practical and effective.