ABSTRACT
Objective@#Application of Clinical and Laboratory Standards Institute evaluation protocols-12 approved guideline 2nd edition (CLSI EP12-A2) and EP15-A2 documents in the performance evaluation of Adenovirus IgM CLIA microparticles.@*Methods@#Referring to the EP15-A2 method , three samples of high and low concentration were selected. Each sample test was repeated 4 times one day for 5 days, and the total imprecision was calculated. Referring to the EP12-A2 method , samples of C50, C50-20% and C50+ 20% were prepared and repeated 40 times, to verify C50±20% bounds the C5~C95 interval. Compared with diagnostic accuracy criteria, the sensitivity and specificity were calculated. Compared with ELISA method , the concordance rate and Kappa value were calculated.@*Results@#The total imprecision CV (%) was less than 8%, lower than that announced by manufacturer. C50±20% concentration fall outside the C5~C95 interval. Compared with diagnostic accuracy criteria, the sensitivity was 100% (95%CI: 79.6%~100%), specificity was 97.8% (95%CI: 94.5%~99.1%), Kappa value was 0.871. Compared with ELISA method , the positive concordance rate was 66.7%(95%CI: 53.6%~77.7%), negative concordance rate was 97.4%(95%CI: 95.4%~98.5%)total concordance rate was 93.9%(95%CI: 91.6%~95.6%), Kappa value was 0.678.@*Conclusions@#The performance of Adenovirus IgM CLIA microparticles can meet clinical requirements.
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.