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.
ABSTRACT
Hepatitis B surface antigen (HBsAg) is a crucial serum marker for the diagnosis of hepatitis B virus (HBV) infection. It is imperative to compare test results from different detection methods based on different principles. Four methods, chemiluminescent microparticle immunoassay (CMIA), electrochemiluminescent immunoassay (ECLIA), enzyme-linked immunosorbent assay (ELISA) and golden immunochromato-graphic assay (GICA) were applied to test the HBsAg level in 250 specimens. According to the EP12-A2 and EP15-A2 documents from Clinical and Laboratory Standards Institute (CLSI), the concentration at which repeated results are 50% positive (C50) of HBsAg detected by CMIA, ECLIA, ELISA and GICA was 0.05, 0.08, 0.15 and 15.0IU/ml, respectively. When the detection concentration of HBsAg was 0.5IU/ml, the imprecision degree of CMIA, ECLIA and ELISA was 8.1%, 5.9% and 14.9% respectively. When detecting high HBsAg level (≥20.0IU/ml) and HBsAg negative specimens, the consistency of the four methods was high, while for the low level (0.05-20.0IU/ml), the consistency was poor (except for the CMIA and ECLIA, P<0.05). When evaluation of the four methods in qualitative diagnosis of HBsAg level in the 116,455 specimens, there was no significant discrepancy among CMIA, CMIA and ECLIA, however, GICA was significantly different from the other 3 methods. Compared with CMIA, the false negative rate of ECLIA, ELISA and GICA was 0.2%, 1.3% and 12.3% respectively. In conclusion, GICA was only suitable for the preliminary screening of HBsAg positive individuals and ELISA can be applied to the qualitative diagnosis of HBsAg. Both CMIA and ECLIA were suitable for the quantitative determination of HBsAg.