[1]王欣俞,赵晋文,张延海,等.四种梅毒血清学检测方法在梅毒抗体不确定样本的分析及评价[J].现代检验医学杂志,2019,34(03):109-111,114.[doi:10.3969/j.issn.1671-7414.2019.03.026]
　WANG Xin-yu,ZHAO Jin-wen,ZHANG Yan-hai,et al.Analysis and Evaluation of Four Syphilis Detection Methodsin Uncertain Samples of Syphilis Antibody[J].Journal of Modern Laboratory Medicine,2019,34(03):109-111,114.[doi:10.3969/j.issn.1671-7414.2019.03.026]
点击复制

四种梅毒血清学检测方法在梅毒抗体不确定样本的分析及评价()
分享到：

《现代检验医学杂志》[ISSN:/CN:]

卷:
第34卷
期数:
2019年03期
页码:
109-111,114
栏目:
研究简报·实验技术
出版日期:
2019-06-20

文章信息/Info

Title:
Analysis and Evaluation of Four Syphilis Detection Methodsin Uncertain Samples of Syphilis Antibody
文章编号:
1671-7414(2019)03-109-04
作者:
王欣俞1; 赵晋文1; 张延海1; 高雅婷1; 孙 斌2; 高德禄1; 魏殿军1; 郭奕阳3
(1.河北燕达医院检验科,河北廊坊 066251; 2.中国人民解放军第三○九医院检验科,北京 100091; 3.河北医科大学第四医院检验科,石家庄 050000)
Author(s):
WANG Xin-yu1; ZHAO Jin-wen1; ZHANG Yan-hai1; GAO Ya-ting1; SUN Bin2; GAO De-lu1; WEI Dian-jun1; GUO Yi-yang3
(1.Departmentof Clinical Laboratory,Hebei Yanda Hospital,Hebei Langfang 066251,China; 2.Department of Clinical Laboratory,the 309th Hospital of the People's Liberation Army,Beijing 100091,China; 3.Department ofClinical Laboratory,the Fourth Hospital of Hebei Medical University,Shijiazhuang 050000,China)
关键词:
梅毒;  化学发光微粒子免疫检测法;  梅毒螺旋体凝胶颗粒凝集试验;  快速血浆反应素环状卡片试验;  梅毒抗体免疫印迹法
分类号:
R377.1; R446.61
DOI:
10.3969/j.issn.1671-7414.2019.03.026
文献标志码:
A
摘要:
目的 探讨应用于梅毒抗体不确定样本的四种梅毒检测方法的分析及评价。方法 纳入于2018年1月～2019年1月期间,河北燕达医院应用美国雅培Architect i2000全自动化学发光仪化学发光微粒子免疫检测法(CMIA),对梅毒筛查结果为1≤S/CO<10的弱反应性的190例人群为研究对象,收集患者的临床资料和实验数据,应用梅毒螺旋体明胶颗粒凝集试验(TPPA)、快速血浆反应素环状卡片试验(RPR)、CMIA梅毒实验室检测方法分别对敏感度、特异度、阳性预测值、阴性预测值、误诊率以及漏诊率进行分析比对。结果 Architect i2000 CMIA初筛S/CO值1～10反应性结果190例,选用TPPA,RPR及TP-WB三种梅毒检测试验方法复核,对四种梅毒试验检测方法进行比较,以梅毒抗体免疫印迹法(TP-WB)检测结果为确认实验标准,检出56例阳性,134例阴性。确证试验显示为56例阳性(占29.5%)。CMIA与TPPA阳性符合率为75.3%(143/190); TPPA结果与TP-WB阳性符合率为28.4%(54/190),误诊率为66.42%(89/134),漏诊率为3.57%(2/56),阴性预测值为95.74%(45/47),RPR现正感染阳性预测值100%(2/2),阴性预测值为100%(188/188)。结论 在梅毒血清临床样本筛查中出现弱反应性结果时,对于检测弱反应性结果不一致的标本应首选用免疫印迹法检测确证,避免临床诊断中漏诊或者误诊发生。
Abstract:
Objective To investigate the analysis and evaluation of four syphilis detection methods in uncertain samples of syphilis antibody.Methods From Jan.2018 to Jan.2019,190 patients inHebei Yanda Hospital were screened for S/CO with a value of less than 1 to <10,the Abbott Architect i2000 automatic chemiluminescence microparticle immunoassay(CMIA).The clinical data and experimental data were collected,and the treponema pallidum particle agglutination(TPPA)was calculated for the sensitivity,specificity,positive predictive value,negative predictive value,misdiagnosis rate and missed diagnosis rate of rapid plasma reactin ring card test(RPR)and CMIA syphilis laboratory detection methods.Results 190 patients with S/CO value(≥1 to <10)were screened by Architect i2000 CMIA,TPPA,RPR and TP-WB were used to check the results.Four syphilis test methods were compared.The results of TP-WB were used as the confirmation standard.56 caseswere positive and 134 cases were negative.Confirmation test showed that 56 cases(29.5%)were positive.The positive coincidence rate between CMIA and TPPA was 75.3%(143/190),the positive coincidence rate between TPPA and TP-WB was 28.4%(54/190),the misdiagnosis rate was 66.42%(89/134),the missed diagnosisrate was 3.57%(2/56),the negative predictive value was 95.74%(45/47),the positive predictive value of RPR was 100%(2/2)and the negative predictive valuewas 100%(188/188).Conclusion When weak reactivity results occur in the screening of syphilis serum clinical samples,immunoblotting should be first used to detect the samples with inconsistent weak reactivity results,avoid missed diagnosis or misdiagnosis in clinical diagnosis.

参考文献/References:

[1] 郑和平,黄进梅,薛耀华,等.梅毒实验室诊断技术与质量控制[M].北京:人民卫生出版社,2015. ZHENG Heping,HUANG Jinmei,XUE Yaohua,et al.Syphilis experimentaldiagnosis technology and quality control[M].Beijing:People's Health Publishing House,2015.
[2] PATTON M E,SU J R,NELSON R,et al.Primary and secondary syphilis-United States,2005～2013[J].MMWR Morb Mortal Wkly Rep,2014,63(18):402-406.
[3] SOMMESE L,SABIA C,ESPOSITO A,et al.Comparison of performance of two treponema pallidum automated chemiluminescent immunoassays in blood donors[J].Infect Dis(Lond),2016,48(6):483-487.
[4] LI Lixin,CAI Bei,TAO Chuanmin,et al.Performance evaluation of CLIA for treponema pallidum specific antibodies detection in comparison with ELISA[J].J Clin Lab Anal,2016,30(3):216-222.
[5] 童曼莉,刘莉莉,林丽蓉,等.梅毒实验诊断程序研究进展[J].中华检验医学杂志,2017,40(11):898-903. TONG Manli,LIU Lili,LIN Lirong,et al.Research progress of laboratory detective algorithms for syphilis[J].Chin J Lab Med,2017,40(11):898-903.
[6] 胡跃华,李镒冲,刘世炜,等.中国20年间淋球菌、性传播衣原体、梅毒螺旋体的发病情况及其疾病负担[J].疾病监测,2015,30(11):904-910. HU Yuehua,LI Yichong,LIU Shiwei,et al.Incidence of gonococcal infection,sexually transmitted chlamydial infection and syphilis and realted disease burden in China,1990-2010[J].Disease Surveiliance,2015,30(11):904-910.
[7] 王勤.梅毒血清学方法检测策略探讨[J].检验医学,2018,33(8):749-751. WANG Qin.Strategies for syphilis serological determination[J].Laboratory Medicine,2018,33(8):749-751.
[8] 唐利利,程玉燕,高金平,等.梅毒免疫学机制研究进展[J].中国麻风皮肤病杂志,2017,33(5):317-320. TANG Lili,CHENG Yuyan,GAO Jinping,et al.Update of the immunopathogenesis of syphilis[J].China Journal of Leprosy and Skin Diseases,2017,33(5):317-320.
[9] 刘成让.TPPA与TPAb检测血清梅毒螺旋体抗体的临床价值分析[J].河南医学研究,2018,27(7):1304-1305. Liu Chengrang.Clinical value of TPPA and TPAb in detecting serum treponema pallidum antibody[J].Henan Medical Research,2018,27(7):1304-1305.
[10] 党倩丽,吴玲智,张小艳,等.重组抗原免疫印迹法与化学免疫发光法检测梅毒假阳性对比分析[J].中国皮肤性病学杂志,2018,32(5):536-540.DANG Qianli,WU Lingzhi,ZHANG Xiaoyan,et al.Comparative studies of recombinant antigen western blot and CMIA to exclude the false positive of syphilis[J].The Chinese Journal ofDermatovenereology,2018,32(5):536-540.
[11] 熊继红,张秀明,卢建强,等.雅培I2000srCMIA法筛查梅毒螺旋体特异性抗体的测量阈值探讨[J]现代检验医学杂志,2012,27(6):105-106.XIONG Jihong,ZHANG Xiuming,LU Jianqiang,et al.Study on measurement threshold of screening specific antibody of treponema pallidum with Abbott I 2000srCMIA method[J].Journal of Modern Laboratory Medicine,2012,27(6):105-106.
[12] 张晓红,张倩,周学红,等.化学发光法检测梅毒特异性抗体在临床筛查试验中的应用评价[J].中华检验医学杂志,2014,37(10):780-783.Zhang Xiaohong,Zhang Qian,Zhou Xuehong,et al.Evaluation of the chemiluminescence immunoassay for diagnosis of syphilis in the clinical screening test[J].Chinese Journal of Laboratory Medicine,2014,37(10):780-783.
[13] 徐飞,刘颖,周淳,等.三种方法学对于梅毒患者血清及脑脊液的临床诊断价值的评估[J].标记免疫分析与临床,2018,25(11):1736-1739.XU Fei,LIU Ying,ZHOU Chun,et al.A study of the clinical diagnostic value three kinds of methodologies for syphilis patients serum and cerebrospinal fluid evaluation[J].Labeled Immunoassays and Clinical Medicine,2018,25(11):1736-1739.

相似文献/References:

[1]徐敬轩a,夏 毅a,谢而付,等.丹阳地区农民梅毒感染状况调查[J].现代检验医学杂志,2016,31(02):141.[doi:10.3969/j.issn.1671-7414.2016.02.043]
　XU Jing-xuana,XIA Yia,XIE Er-fu,et al.Investigation on the Status of Farmers of Syphilis Infection in Danyang Area[J].Journal of Modern Laboratory Medicine,2016,31(03):141.[doi:10.3969/j.issn.1671-7414.2016.02.043]
[2]于连辉,崔京涛,贾妍,等.梅毒实验诊断中增强化学发光技术与其它血清学比对以及在急诊筛查流程的探讨[J].现代检验医学杂志,2015,30(05):123.[doi:10.3969/j.issn.1671-7414.2015.05.038]
　YU Lian-hui,CUI Jing-tao,JIA Yan,et al.Commparision of Enhanced Chemiluminescence Technologies with Other Syphilis Serology and the Application for Screening Procedure in a Stat Laboratory[J].Journal of Modern Laboratory Medicine,2015,30(03):123.[doi:10.3969/j.issn.1671-7414.2015.05.038]
[3]吴晓康a,张妮a,尹佳锋a,等.大样本人群血清梅毒抗体检测结果分析[J].现代检验医学杂志,2015,30(06):130.[doi:10.3969/j.issn.1671-7414.2015.06.040]
　WU Xiao-kanga,ZHANG Nia,YIN Jia-Fenga,et al.Analysis on Syphilis Detection Results of Large Populations[J].Journal of Modern Laboratory Medicine,2015,30(03):130.[doi:10.3969/j.issn.1671-7414.2015.06.040]
[4]安 哲,王香玲.2014版欧洲梅毒管理指南(实验室诊断部分)[J].现代检验医学杂志,2016,31(04):162.[doi:10.3969/j.issn.1671-7414.2016.04.048]
[5]王 欢,朱参胜,蔺兆星,等.陕西省梅毒血清学检测室间质量评价结果分析[J].现代检验医学杂志,2017,32(01):157.[doi:10.3969/j.issn.1671-7414.2017.01.044]
　WANG Huan,ZHU Can-sheng,LIN Zhao-xing,et al.External Quality Assessment of Syphilis Serological Tests in Shaanxi[J].Journal of Modern Laboratory Medicine,2017,32(03):157.[doi:10.3969/j.issn.1671-7414.2017.01.044]
[6]徐敬轩,夏 毅,彭文红,等.梅毒筛查中甲苯胺红不加热血清试验改良方法与传统方法的比较[J].现代检验医学杂志,2017,32(03):133.[doi:10.3969/j.issn.1671-7414.2017.03.037]
　XU Jing-xuan,XIA Yi,PENG Wen-hong,et al.Comparison of the Improved Method and the Traditional Method for Toluidine Red Unheated Serum Test in Syphilis Screening[J].Journal of Modern Laboratory Medicine,2017,32(03):133.[doi:10.3969/j.issn.1671-7414.2017.03.037]
[7]谭梅娟,李 靖.精神分裂症患者梅毒感染的流行病学调查[J].现代检验医学杂志,2018,33(04):125.[doi:10.3969/j.issn.1671-7414.2018.04.034]
　TAN Mei-juan,LI Jing.Study on Syphilis Infection among Inpatients with Schizophrenia[J].Journal of Modern Laboratory Medicine,2018,33(03):125.[doi:10.3969/j.issn.1671-7414.2018.04.034]
[8]蔺兆星,郭博阳,王耀斐,等.2018 ～ 2019 年陕西省临床实验室梅毒血清学室间质评结果分析[J].现代检验医学杂志,2020,35(02):153.[doi:10.3969/j.issn.1671-7414.2020.02.042]
　LIN Zhao-xing,GUO Bo-yang,WANG Yao-fei,et al.Analysis on the External Quality Assessment of Syphilis Serological Testsin Shaanxi Clinical Laboratories from 2018 to 2019[J].Journal of Modern Laboratory Medicine,2020,35(03):153.[doi:10.3969/j.issn.1671-7414.2020.02.042]
[9]彭振亚,张银辉,陈安宁,等.变性梅毒重组抗原免疫印迹技术的建立及其在鉴别梅毒血清学假阳性实验的应用[J].现代检验医学杂志,2023,38(02):150.[doi:10.3969/j.issn.1671-7414.2023.02.028 ]
　PENG Zhen-ya,ZHANG Yin-hui,CHENan-ning,et al.Build of Immunoblotting Technique Using Denatured Recombinant Antigen of T. pallidum and Application to Identify False Positive Serum Test Results of Syphilis[J].Journal of Modern Laboratory Medicine,2023,38(03):150.[doi:10.3969/j.issn.1671-7414.2023.02.028 ]

备注/Memo

备注/Memo:
基金项目:河北省卫生青年科技课题项目(20180899)。 作者简介:王欣俞(1983-),女,本科,副主任技师,从事临床免疫学检验,E-mail:532161952@qq.com。 通讯作者:魏殿军(1962-),男,博士研究生,教授,从事临床免疫学检验,E-mail:1127089887@qq.com。 收稿日期:2018-11-08 修回日期:2019-04-26
更新日期/Last Update: 2019-06-20