化学发光法检测梅毒特异性抗体的临床分析

Clinical analysis of detection of syphilis specific antibody by chemiluminescence method

目的评价化学发光法检测梅毒螺旋体特异性抗体的效果。方法选取手术或输血前5569例患者的血清样品,分别用酶联免疫吸附试验(ELISA)、化学发光检测法(CLIA)和梅毒螺旋体明胶颗粒凝胶试验(TPPA)进行梅毒筛查。以TPPA结果为金标准,分析CLIA和ELISA检测方法的灵敏度和特异度、阳性结果预测值和阴性结果预测值。结果5569例血清样品中,TPPA检测阳性139例(2.5%)。以TPPA作参照,CLIA检测的灵敏度为100.0%(139/139),特异度为99.3%(5391/5430),阳性预测值为78.1%(139/178),阴性预测值为100.0%(5391/5391);ELISA检测的灵敏度为97.8%(136/139),特异度为97.9%(5315/5430),阳性预测值为54.2%(136/251),阴性预测值为99.9%(5315/5318);CLIA与ELISA检测方法比较,CLIA检测的特异度和阳性预测值高于ELIA(P<0.01);两种检测方法的灵敏度和阴性预测值比较,差异无统计学意义(P>0.05)。结论CLIA法具有特异度和阳性预测值高的特点,适合于临床实验室进行手术前及输血前梅毒的筛查。

Objective To evaluate the effect of chemiluminescence method in the detection of syphilis specific antibody.Methods Serum samples from 5569 patients before surgery or transfusion were selected for syphilis screening by enzyme-linked immunosorbent assay(ELISA),chemiluminescence assay(CLIA)and treponema pallidus gelatin particle gel test(TPPA).TPPA results were used as the gold standard to analyze the sensitivity and specificity,positive predictive value and negative predictive value of CLIA and ELISA methods.Results Among 5569 serum samples,139 cases(2.5%)were positive for TPPA.Taking TPPA as a reference,the sensitivity of CLIA detection was 100.0%(139/139),the specificity was 99.3%(5391/5430),the positive predictive value was 78.1%(139/178),and the negative predictive value was 100.0%(5391/5391).ELISA detection sensitivity is 97.8%(136/139),specificity is 97.9%(5315/5430),positive predictive value is 54.2%(136/251),negative predictive value is 99.9%(5315/5318).Compared with the detection methods of CLIA and ELISA,the specificity and positive predictive value of CLIA were higher than those of ELISA(P<0.01).The sensitivity and negative predictive value of the two detection methods were not statistically different(P>0.05).Conclusion CLIA method has the characteristics of specificity and high positive predictive value,and is suitable for clinical laboratory screening for syphilis before surgery and blood transfusion.