RESUMO
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.