化学发光法检测梅毒特异性抗体的临床应用  

The clinical application of chemiluminescence method in the detection of syphilis specific antibody

作　　者：应丽娜 韩雯清 张丹晨[1] 王璐 徐冉行[1] YING Li-na;HAN Wen-qing;ZHANG Dan-chen;WANG Lu;XU Ran-xing(Clinical Laboratory,Ningbo Sixth Hospital,Ningbo,Zhejiang 315004,China)

机构地区：[1]宁波市第六医院检验科,浙江宁波315004

出　　处：《中国卫生检验杂志》2022年第20期2536-2539,2557,共5页Chinese Journal of Health Laboratory Technology

摘　　要：目的评估化学发光法(CLIA)检测梅毒特异性抗体在临床诊断中的应用价值。方法收集3976例临床标本,分别用CLIA法和ELISA法进行梅毒特异性抗体检测,对于检出有反应的血清标本,再运用梅毒螺旋体颗粒凝集试验(TPPA)结合免疫印迹法(WB)进行复检。结果3976例临床检测标本中,用CLIA法筛检出TP抗体阳性167例,ELISA法筛检出TP抗体阳性156例,经χ^(2)检验,两者结果差异无统计学意义(χ^(2)=0.323,P>0.05)。筛查出167例TP阳性标本,采用TPPA法复检,有142例检测结果为阳性;23例检测结果为阴性;2例检测结果为可疑。采用WB法复检,有133例检测结果为阳性;22例检测结果为阴性;12例结果为可疑。最终结合患者临床资料,与临床确诊一致的结果有134例。TPPA与WB法复查结果比较,差异有统计学意义(χ^(2)=7.460,P<0.05)。以WB阳性结果为标准,CLIA检测TP抗体的曲线下面积为1,CLIA S/CO值的最佳临界值为11.55,敏感度为99.2%,特异度为100%,Youden指数为0.992。结论采用CLIA法筛查TP抗体的逆向策略具有灵敏度高、特异度高、检测效率高等优点。当CLIA检测梅毒螺旋体结果为弱反应性时,建议加做WB进行复查,再结合患者生理情况或基础疾病等因素进行综合分析,不能将CILA检测作为临床梅毒诊断依据,避免误诊。Objective To evaluate the clinical value of chemiluminescence(CLIA)in detecting specific antibodies to syphilis.Methods A total of 3976 clinical specimens were collected,and syphilis specific antibodies were respectively detected by CLIA and enzyme-linked immunosorbent assay(ELISA).The positive samples will be conducted for the reexamination of treponema pallidum particle agglutination test(TPPA)combined with western blot(TPWB).Results Among 3976 clinical samples,167 were positive for TP antibody by CLIA and 156 were positive for TP antibody by ELISA.There was no statistical significance on the difference between the two results(χ^(2)=0.323,P>0.05).167 TP-positive specimens were screened and reexamined by TPPA method,142 of which were positive;23 cases were negative.The results of 2 cases were suspicious.TPWB was used for reexamination,133 cases were positive and 22 cases were negative.The results were suspicious in 12 cases.Finally combined with the clinical data of patients,the results were consistent with the clinical diagnosis of 134 cases.The reexamination results between TPPA and WB showed statistical significance(χ^(2)=7.460,P<0.05).Using WB positive result as standard,the area under the curve(AUC)of CLIA for detecting TP antibody was 1,the optimal critical value of CLIA S/CO value was 11.55,sensitivity was 99.2%,specificity was 100%,and Youden index was 0.992.Conclusion CLIA reverse strategy screening TP antibody has the advantages of high sensitivity,high specificity and high detection efficiency.When CLIA test results of Treponema pallidum showed weak reactivity,WB was recommended for reexamination,and then comprehensive analysis was carried out in combination with the patient’s physiological conditions or underlying diseases,so CILA test could not be used as the basis for clinical diagnosis of syphilis to avoid misdiagnosis.

关 键 词：梅毒特异性抗体 逆向策略 化学发光法 免疫印迹法 

分 类 号：R446[医药卫生—诊断学]