梅毒螺旋体明胶凝集试验对酶联免疫吸附试验法和金标法梅毒抗体检测的结果评价

TPPA method for evaluating ELISA method and colloidal gold method in detection results of syphilis antibody

目的应用梅毒螺旋体明胶凝集试验(TPPA)法对ELISA法和胶体金法梅毒血清学检测试剂的临床适用性进行评价。方法收集6 291例临床手术前或输血前住院患者的血清标本,采用ELISA法(试剂A、试剂B)和金标法分别进行初筛检测,初筛阳性或弱阳性标本用TPPA法做确证试验。结果血清标本6 291份中,试剂A、试剂B、金标法检测阳性分别为66、64、56份,金标法阳性检出率与试剂A、B比较,差异无统计学意义(P>0.05)。阳性标本经TPPA确证为66份,其中试剂A、试剂B阳性均为61份,金标法为56份。试剂A检测为阳性的5份标本及试剂B检测为阳性的3份标本,经TPPA确证为阳性的分别为3、2份,金标法灵敏度与试剂A、B比较差异有统计学意义(P<0.05)。结论 ELISA法灵敏度高,易实现自动化酶联免疫分析,适合临床手术前或输血前患者标本的筛查,金标法灵敏度低,但特异度高,方法简捷,适用于大规模健康体检及急诊手术前的初筛试验。为避免医疗纠纷,对ELISA法和金标法阳性的标本应用TPPA法来确诊。

Objective To use the syphilis helicoid gelatin aggregation experiment （TPPA） method to compare the results of syphilis serological detection reagents between the ELISA method and the colloidal gold method for evaluating the clinical applica- bility of each detection reagent. Methods 6 291 serum samples were selected from the hospitalized patients before surgery or before blood transfusion, and performed the preliminary screening detection by the ELISA method （reagent A and B） and the colloidal gold method,the positive or weakly positive specimens in preliminary screening were performed the confirmation test by the TPPA method. Results In 6 291 serum specimens,the positive cases of the reagent A, reagent B and colloidal gold method were 66,64 and 56 cases respectively,the positive detection rate of colloidal gold method had no obvious difference between the reagent A and rea- gent B （P≥0.05）. The positive samples were confirmed to be 66 cases by TPPA,including 61 cases of reagent A and reagent B positive,and the colloidal gold method had 56 cases. 5 cases of reagent A positive and 3 cases of reagent B positive were confirmed to be 3 and 2 cases by TPPA respectively,the sensitivity of the colloidal gold method had significant difference between the reagent A and reagent B（P〈0.05）. Conclusion ELISA method has high sensitivity and is easy to realize the automated enzyme-linked im- munoassay,which is suitable for the screening of the patient sample before surgery or before blood transfusion. The colloidal gold method has low sensitivity,but high specificity,is simple and convenient which is suitable for large-scale healthy physical examina- tion and preliminary screening test before emergency surgery. In order to avoid medical disputes, the positive samples by the ELISA method and colloidal gold method should he confirmed by the TPPA method.