Zhou Jiansuo, Liang Yongming, Zhang Jie, Cui Liyan
Department of Clinical Laboratory, Peking University Third Hospital, Beijing, China.
Medicine (Baltimore). 2017 Jun;96(24):e7139. doi: 10.1097/MD.0000000000007139.
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.
评估电化学发光免疫分析仪（ECLIA）和化学发光磁微粒免疫分析（CMIA）在梅毒螺旋体（TP）检测中的临床应用价值。选取2014年6月至2014年10月北京大学第三医院的1225例患者。采用ECLIA和CMIA检测血清抗TP，分析阳性率。以免疫印迹法（RIBA）作为金标准，评估ECLIA和CMIA的敏感性、特异性、阳性预测值、阴性预测值及准确性。对两种检测方法之间以及检测方法与RIBA之间进行相关性分析。同时评估梅毒螺旋体颗粒凝集试验（TPPA）在梅毒检测中的临床价值。CMIA和ECLIA的阳性率分别为10.63%和9.89%，差异无统计学意义（P＞0.05）。CMIA、ECLIA和TPPA的敏感性分别为99.16%、99.16%和99.16%，特异性分别为98.99%、99.82%和100%，阳性预测值分别为91.47%、98.33%和100%，阴性预测值分别为99.91%、99.91%和99.91%，符合率分别为99.01%（Kappa = 0.895）、99.75%（Kappa = 0.997）和99.92%（Kappa = 0.998）。结果显示ECLIA与CMIA之间具有高度相关性。两者均具有较高的敏感性和特异性，可作为一般情况下梅毒诊断的筛查试验。
