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

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Abstract

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.

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