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 assess the association of polymorphism at rs12645561 locus of Nei endonuclease Ⅷ-like 3 ( NEIL3) gene with the severity of coronary atherosclerosis in Han population of Hubei and Henan regions in central China. Methods In 947 cases undergoing coronary angiography, the severity of coronary atherosclerosis was calculated by lesion vessel number scores and Gensini scores.The genotypes of rs12645561 were analyzed by high resolution melting curve. The plasma NEIL3 levels were measured by en-zyme-linked immunosorbent assay. Results The minor allele T of rs12645561 was significantly associated with the risk of coronary ar-tery disease (χ2=12.165, P<0.05) including increased lesion vessel scores and Gensini scores (χ2=14.745 and 15.615,P<0.05). The variant risk genotypes ( CC+CT) of rs12645561, body mass index of more than 25 kg/m2 , hypelipidemia and smoking habit were all the independent risk factors for higher Gensini scores ( OR=1.50, 1.54, 2.01 and 1.42, respectively, P<0.05) . There were signifi-cantly inverse correlations of plasma NEIL3 levels with the distribution of rs12645561, lesion vessel number scores and Gensini scores ( P<0.05) . Conclusion rs12645561 may correlate with the severity of coronary atherosclerosis, and contribute to the development of coronary atherosclerosis of Han population of Henan and Hubei regions. rs12645561 may also affect the levels of NEIL3 protein.