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目的对罗氏电化学发光免疫法(ECLIA)检测梅毒螺旋体特异性抗体的临床价值进行评估。方法收集梅毒疑似病例血清标本132份,分别用ECLIA、梅毒螺旋体明胶凝集试验(TPPA)和免疫印迹法(WB)进行检测,以WB为金标准,计算并比较ECLIA和TPPA的灵敏度和特异性,进而比较化学发光免疫法检测低S/CO值和高S/CO值的灵敏度和特异性差异。结果针对132份血清标本,ECLIA敏感性为100.00%,特异性为83.33%,阳性预测值为96.43%,阴性预测值为100.00%,总符合率为96.97%。TPPA敏感性为93.52%,特异性为87.50%,阳性预测值为97.12%,阴性预测值为75.00%,总符合率为92.42%。ECLIA检测1≤S/CO<3组与S/CO≥3组的敏感性均为100.00%,特异性分别为86.96%和95.24%,结论 ECLIA检测具有较高的敏感性,适合临床大样本筛查,对S/CO值低的标本应结合TPPA、WB及临床资料确诊。
Objective To evaluate the clinical value of Roche Electrochemiluminescence Immunoassay (ECLIA) for detection of Treponema pallidum-specific antibodies. Methods Totally 132 serum samples from suspected cases of syphilis were collected and detected by ECLIA, TPPA and WB. The sensitivity and specificity of ECLIA and TPPA were calculated and compared with the gold standard of WB. Then compare the sensitivity and specificity of chemiluminescence immunoassay to detect low S / CO value and high S / CO value. Results For 132 serum samples, the ECLIA sensitivity was 100.00%, the specificity was 83.33%, the positive predictive value was 96.43%, the negative predictive value was 100.00%, the total coincidence rate was 96.97%. TPPA sensitivity was 93.52%, specificity was 87.50%, positive predictive value was 97.12%, negative predictive value was 75.00%, the total coincidence rate was 92.42%. The sensitivity of ECLIA for detection of 1≤S / CO <3 and S / CO≥3 were 100.00% and 86.96% and 95.24%, respectively. Conclusion The ECLIA assay has high sensitivity and is suitable for screening large clinical samples Check, the S / CO value of low specimens should be combined TPPA, WB and clinical data confirmed.