两种平台检测梅毒螺旋体抗体的临床应用价值分析  

An Analysis of the Clinical Application Value on Two Platforms for theDetection of Treponema Pallidum Antibody

作　　者：赵亚虹[1] 李振文[1] 冯睿 贾兴旺 ZHAO Yahong;LI Zhenwen;FENG Rui;JIA Xingwang(Beijing Electric Power Teaching Hospital,Capital Medical University,Beijing 100073,China)

机构地区：[1]首都医科大学北京电力教学医院,北京100073

出　　处：《标记免疫分析与临床》2023年第8期1411-1415,共5页Labeled Immunoassays and Clinical Medicine

摘　　要：目的 以梅毒颗粒凝集试验(treponema pallidum particle agglutination assay, TPPA)为确认方法,探讨雅培Ci8200及迈瑞CL6000i两种检测平台在采用化学发光法检测梅毒特异性抗体初筛中的应用价值。方法 采用雅培Ci8200平台或迈瑞CL6000i平台中的一种对梅毒特异性抗体初筛,另一种为之复核,再采用TPPA进行确认,得到雅培Ci8200、迈瑞CL6000i、TPPA检测的阳性数、阴性数,进一步对数据进行分析。结果 雅培Ci8200及迈瑞CL6000i特异性分别为56.38%、50.96%,阳性预测值分别为62.73%、57.50%。初筛阳性样本S/CO值为1~10时,两种平台均出现TPPA复核呈阴性的结果,S/CO值>10时,TPPA复核均呈阳性。S/CO为4.985是雅培Ci8200的最佳诊断截断值,灵敏度为85.5%,特异性为92.5%,约登指数为0.780,AUC为0.943;S/CO为6.1是迈瑞CL6000i的最佳诊断截断值,灵敏度为87.0%,特异度为86.8%,约登指数为0.7375,AUC为0.932。结论 以TPPA为确认试验,雅培Ci8200及迈瑞CL6000i的S/CO值>10时,阳性符合率达100%。雅培Ci8200阳性预测值和特异性略优于迈瑞CL6000i, S/CO的最佳诊断截断值小于迈瑞CL6000i的最佳诊断截断值。雅培Ci8200及迈瑞CL6000i均是梅毒特异性抗体初筛的理想方法,当S/CO值>10.00时无需对样本进行复查。Objective Using treponema pallidum partical agglutination assy(TPPA)as the confirmation method,the application value of Architect Ci8200 and Mindray CL6000i platforms in the preliminary screening for the detection of syphile specific antibodies was evaluated.Methods The positive samples were initially screened on either Architect Ci8200 or Mindray CL6000i platform,and the results were re-checked on the other platform,and then confirmed by TPPA.Results The specificity of Architect Ci8200 and Mindray CL6000i were 56.38%and 50.96%,respectively,while the positive predictive values were 62.73%and 57.50%respectively.When the initial screening positive sample S/CO value was between1-10,the TPPA re-check results were negative for both platforms,and when the S/CO value was>10,the TPPA re-check results were positive.S/CO of 4.985 was the best diagnostic cut-off value for Architect Ci8200,with the sensitivity of 85.5%,the specificity of 92.5%,the Jordon index of 0.780,and the AUC of 0.943.S/CO of 6.1 was the best diagnostic cut-off value for Mindray CL600i,with 87.0%sensitivity,86.8%specificity,0.7375 Yodon index and 0.932 AUC.Conclusion When S/CO value is greater than 10,the positive coincidence rate is 100%.The positive predictive value and specificity of Architect Ci8200 are better than Mindray CL6000i,and the best diagnostic cut-off value of S/CO is lower than that of Mindray CL6000i.Architect Ci8200 and Mindray CL6000i are both ideal for primary screening of treponema pallidum specific antibodies.Re-examine samples is unnecessary when S/CO values are greater than 10.00.

关 键 词：梅毒特异性抗体 雅培Ci8200 迈瑞CL6000i 化学发光法 

分 类 号：R-331[医药卫生] R377.1