The analyzation and clinical evaluation of ECLIA and CMIA in the detection of Treponema pallidum

摘要

To evaluate the clinical application value of electrochemiluminescence immunoassay analyzer (ECLIA) and chemiluminescent magnetic microparticle immunoassay (CMIA) in the detection of Treponema pallidum (TP).A total of 1225 patients in Peking University Third Hospital was enrolled from June 2014 to October 2014. ECLIA and CMIA were applied to detect the serum anti-TP. The positive rate was analyzed. RIBA was taken as a golden standard to evaluate the sensitivity, the specificity, the positive predictive value, the negative predictive value, and the accuracy of ECLIA and CMIA. A correlation analysis between 2 assays was conducted, and that between assay and RIBA. We also evaluate the clinical value of TPPA in the detection of T pallidum.The positive rate of CMIA and ECLIA is 10.63% and 9.89%, respectively, showing no statistically significant difference (P > .05). For CMIA, ECLIA, and TPPA, the sensitivity is 99.16%, 99.16%, and 99.16%, the specificity is 98.99%, 99.82%, and 100%, the positive predictive value is 91.47%, 98.33%, and 100%, the negative predictive value is 99.91%, 99.91%, and 99.91%, the coincidence rate is 99.01% (Kappa = 0.895), 99.75% (Kappa = 0.997), and 99.92% (Kappa = 0.998), respectively.The result shows high correlation between ECLIA and CMIA. Both have high sensitivity and specificity and can be used as screening tests for the diagnosis of T pallidum in common condition.