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目的评价化学发光微粒子免疫法(chemiluminescence microparticle immunoassay,CMIA)检测临床血清标本梅毒螺旋体抗体的敏感性和特异性。方法用梅毒螺旋体颗粒凝集试验(Treponema Pallidum particie agglutination test,TPPA)法作为对照标准,采用CMIA法检测2012年11月到12月1200例住院患者的血清标本,并用卡方检验评价两种检测方法对同一个样本的化验结果的一致性。结果 1200例血清标本中用CMIA法检出阳性率为11.3%,TPPA法检出阳性率为10.9%,以TPPA为标准,CMIA法敏感性为96.9%,特异性为99.2%,其中CMIA法检测血清S/CO值>4.00的110例,用TPPA确认107例阳性,阳性预测值(PPV)为97.3%;CMIA法S/CO值在1.0~9.0,TPPA可出现阴性结果。结论 CMIA法可替代TPPA法进行梅毒螺旋体抗体检测,对于CMIA法检测S/CO值1.0~4.0的需进一步复检。
Objective To evaluate the sensitivity and specificity of chemiluminescence microparticle immunoassay (CMIA) for the detection of syphilis antibodies in clinical serum samples. Methods Serum samples of 1200 inpatients from November to December in 2012 were detected by CMIA method and Treponema Pallidum particie agglutination test (TPPA) method was used as the control standard. The chi-square test was used to evaluate the two detection methods The same sample of the test results of consistency. Results The positive rate of CMIA method was 11.3% in 1200 serum samples and 10.9% in TPPA method. The sensitivity and specificity of CMIA method were 96.9% and 99.2% In 110 cases with serum S / CO value> 4.00, 107 cases were positive with TPPA and the positive predictive value (PPV) was 97.3%. The S / CO values of CMIA method ranged from 1.0-9.0. Conclusion The CMIA method can replace the TPPA method for the detection of Treponema pallidum antibody. For CMIA method, the S / CO value 1.0 ~ 4.0 need further retest.