Evaluation Of The Clinical Performance Differences Between CLIA And ELISA In Measuring ACL And A?2GP?

Objectives:The purpose of this study was to adjust the cut-off values of chemiluminescent immunoassay(CLIA)kit and enzyme linked immunosorbent assay(ELISA)kit for Provincial Hospital Affiliated to Shandong University,according to the 99th percentile of anticardiolipin(aCL)and anti-?2-Glycoprotein(a?2GPI)concentration in healthy control,and then to compare the performance differences between the CLIA kit and the ELISA kit,aiming to evaluate their clinical values.Methods:A total of 112 normal reproductive age women and 104 female patients,including 32 APS patients,50 suspicious APS patients,22 patients with connective tissue disease,were enrolled in this study.Serum samples were collected and aCL and a?2GPI were detected by QUANTA Flash CLIA kit(INOVA Diagnostics)and ELISA kit(EUROIMMUN Diagnostics).All data were analyzed by SPSS 25.0 statistical software.Results:(1)There were statistical differences in the all antibody concentration between APS group and normal control by CLIA kits,but there was no statistical difference in the concentration of aCL-IgM and a?2GPI-IgAby ELISA kits compared with normal control.(2)The cut-off values of both CLIA and ELISA kit were adjusted.(3)CLIA kit had higher sensitivity of aCL-IgA?aCL-IgG?aCL-IgM?a?2GP-I-IgA compared to ELISA kit,same of a?2GPI-IgG,and lower of a?2GPI-IgM.The specificity of all antibodies performed well.(4)The consistency of antibody titer between the two kits was different.The results of aCL-IgG and a?2GP-IgG antibodies performed well,but the aCL-IgA was poor.(5)CLIA assay and ELISA assay were correlated(p<0.05),the Speannan rho ranged from 0.2792 to 0.6025,showing poor to moderate correlation.(6)The area under the receiver operating characteristic curve of aCL-IgA?aCL-IgG?aCL-IgM?a?2GPI-IgA by CLIA kit were larger than ELISA method(p<0.05),opposite results in a?2GPI-IgG and a?2GPI-IgM(p<0.05).Conclusion:(1)Different aPLs detection kits should adjust its cut-off value according to the 99 percentile of the nonnal control in different regions.(2)According to the clinical criteria,CLIA and ELISA kits have different advantages in performance.CLIA kit has higher sensitivity and specificity for aCL-IgM and aCL-IgG antibodies,and its had both technological advantages and superior diagnostic value than ELISA kit;ELISA kit has more diagnostic value for a(32GPI-IgG and a?2GPI-IgM antibodies.(3)Combinding test with aCL-IgA or a?2GPI-IgA antibodies,the diagnostic rate seemed not be improved.