[1]张保平,刘 珊,韩艳秋.使用化学发光法检测26707例血清抗梅毒螺旋体特异性抗体以及结果假阳性率分析[J].现代检验医学杂志,2015,30(02):70-73.[doi:10.3969/j.issn.1671-7414.2015.02.022]
　ZHANG Bao-ping,LIU Shan,HAN Yan-Qiu.Analyze of the False Positive Rate of Serum Anti Treponema Pallidum Specific Antibody of 26 707 Cases Detected by Chemiluminescence Method[J].Journal of Modern Laboratory Medicine,2015,30(02):70-73.[doi:10.3969/j.issn.1671-7414.2015.02.022]
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使用化学发光法检测26707例血清抗梅毒螺旋体特异性抗体以及结果假阳性率分析()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第30卷
期数:
2015年02期
页码:
70-73
栏目:
论著
出版日期:
2015-03-20

文章信息/Info

Title:
Analyze of the False Positive Rate of Serum Anti Treponema Pallidum Specific Antibody of 26 707 Cases Detected by Chemiluminescence Method
作者:
张保平; 刘 珊; 韩艳秋
内蒙古医科大学附属医院检验科,呼和浩特 010050
Author(s):
ZHANG Bao-ping; LIU Shan; HAN Yan-Qiu
Derpartment of Clinical Laboratory, the Affiliated Hospital of Inner Mongolia Medical University,Huhhot 010050,China
关键词:
梅毒螺旋体特异性抗体;  雅培I2000SR全自动化学发光微粒子免疫分析仪;  梅毒螺旋体抗体明胶颗粒凝集试验;  假阳性率;  分析
分类号:
R377.1; R392.11
DOI:
10.3969/j.issn.1671-7414.2015.02.022
文献标志码:
A
摘要:
目的 用雅培I2000SR全自动化学发光微粒子免疫分析仪检测26 707例血清抗梅毒螺旋体特异性抗体,以梅毒螺旋体抗体明胶颗粒凝集试验法(TPPA)作为检查抗梅毒螺旋体特异度抗体标准参考方法,分析判定雅培I2000SR全自动化学发光微粒子免疫分析仪检测的假阳性率。方法 收集内蒙古医科大学附属医院2013年9月1日～2014年3月5日的住院和门诊患者26 707人份血清,要求受检者空腹条件下采取静脉血3 ml,3 000 r/min离心10 min后分离血清,上机检测。使用化学发光微粒子免疫分析(CMIA)、明胶颗粒凝集试验法(TPPA)对血清梅毒螺旋体特异性抗体(Anti-TP)进行检测。运用统计学方法对检测结果进行分析。结果 雅培I2000SR全自动化学发光微粒子免疫分析仪检测的26 707例血清梅毒螺旋体特异性抗体S/CO值在1～的标本数52例,经TPPA验证阳性数9例,阳性率17.31%; S/CO值在2～的标本数26例,阳性数9例,阳性率34.62%; S/CO值在3～的标本数26例,阳性数9例,阳性率34.62%; S/CO值在5～的标本数25例,阳性数11例,阳性率44%; S/CO值在7～的标本数25例,阳性数17例,阳性率68%; S/CO值在10～的标本数28例,阳性数24例,阳性率85.71%; S/CO值在13～的标本数23例,阳性数20例,阳性率86.96%; S/CO值在17～的标本数24例,阳性数22例,阳性率91.67%; S/CO值在21～的标本数29例,阳性数28例,阳性率96.55%; S/CO值在26的标本数104例,阳性数104例,阳性率100%; 总初筛阳性例数364例,总真阳性例数254例,阳性率69.78%; 假阳性率0.42%,阳性预测值69.78%。结论 雅培I2000SR全自动化学发光微粒子免疫分析仪采用自动化检测、全封闭试剂,具有操作简单、检测速度快、结果更准确等特点。虽然其灵敏度高,但存在一定的假阳性,不可以仅凭其结果进行诊断,还需要TPPA方法进行补充检测确证。
Abstract:
Objective To detect serum anti-Treponema pallidum specific antibody of 26 707 cases by Abbott I2000SR automatic chemiluminescent microparticle immunoassay analyzer,and treponema pallidum particle agglutination assay(TPPA)was regarded as a standard reference method which was used to detect anti-Treponema pallidum specific antibody.To analyze the false positive rate of Abbott I2000SR according to the TPPA.Methods Collected 26 707 serums from inpatients and outpatients of the hospital during September 1,2013 to March 5,2014.The subjects were asked to fasting conditionstaking venous blood 3 ml,3 000 r/min centrifugal 10 min utes after the separation of serum,detected the Anti-TP by CMIA(Abbott I2000SR)and the TPPA testing,analyzed test results by statistical methods.Results There were 52 cases detected by I2000SR whose S/CO values of 26 707 cases of serum Treponema pallidum specific antibodies were 1 to 2,of which 9 cases were verified positive by TPPA,and the positive rate was 17.31%.There were 26 cases detected by I2000SR whose S/CO values of Treponema pallidum specific antibodies were 2 to 3,of which 9 cases were verified positive by TPPA,and the positive rate was 34.62%.There were 26 cases detected by I2000SR whose S/CO values of Treponema pallidum specific antibodies were 3 to 5,of which 9 cases were verifiedpositive by TPPA,and the positive rate was 34.62%.There were 25 cases detected by I2000SR whose S/CO values of Treponema pallidum specific antibodies were 5to 7,of which 11 cases were verified positive by TPPA,and the positive rate was 44%.There were 25 cases detected by I2000SR whose S/CO values of Treponema pallidum specific antibodies were 7 to 10,of which 17 cases were verified positive by TPPA,and the positive rate was 68%.There were 28 cases detected by I2000SR whose S/CO values of Treponema pallidum specific antibodies were 10 to 13,ofwhich 24 cases were verified positive by TPPA,and the positive rate was 85.71%.There were 23 cases detected by I2000SR whose S/CO values of Treponema pallidum specific antibodies were 13 to 17,of which 20 cases were verified positive byTPPA,and the positive rate was 86.96%.There were 24 cases detected by I2000SR whose S/CO values of Treponema pallidum specific antibodies were 17 to 21,ofwhich 22 cases were verified positive by TPPA,and the positive rate was 91.67%.There were 29 cases detected by I2000SR whose S/CO values of Treponema pallidum specific antibodies were 21 to 26,of which 28 cases were verified positive byTPPA,and the positive rate was 96.55%.There were 104 cases detected by I2000SR whose S/CO values of Treponema pallidum specific antibodies were above 26,ofwhich 104 cases were verified positive by TPPA,and the positive rate was 100%.The total number of positive cases were 364,of which 254 were positive cases,the positive rate was 69.78%.False positive rate was 0.42% and positive predictive value was 69.78%.Conclusion Abbott I2000SR automated chemiluminescent microparticle immunoassay analyzer has the feature of automated detection,closed reagents,simple operation,speed,and more accurate results and so on.Although high sensitivity but its results have false positive,so cannot diagnose based on the results of Abbott I2000SR,and need use of the TPPA to test and corroborate.

参考文献/References:

[1] 中华人民共和国卫生部.中国预防与控制梅毒规划(2010年～2020年)[S].北京:卫生部,2010. Ministry of Health of the People's Republic of China.China syphilis prevention and control plan(2010-2020)[J].Beijing:Ministry of Health,2010.
[2] 尹跃平.性传播疾病实验室诊断指南[M].上海:上海科学技术出版社,2007:4-14. Yin YP.Sexually transmitted diseases laboratory diagnostic guidelines[M].Shanghai:Shanghai Science and Technology Press,2007:4-14.
[3] 谭延国,张 岩,李 琦.微粒子化学发光法检测梅毒抗体的临床应用[J].中华检验医学杂志,2009,32(1):90-91. Tan YG,Zhang Y,Li Q.Clinical applications of che-miluminescentdetection of syphilis antibodies[J].Journal of Laboratory Medicine,2009,32(1):90-91.
[4] Marangoni A,Moroni A,Accardo S,et al.Laboratory diagnosis of syphiliswith automated immunoassays[J].Journal of Clinical Laboratory Analysis,2009,23(1):1-6.
[5] 王长海,吕长坤.梅毒螺旋体感染筛选方法的临床研究[J].国际检验医学杂志,2010,31(6):609. Wang CH,L(¨overu)ZK.Clinical studies of syphilis screening method[J].International Journal of Laboratory Medicine,2010,31(6):609.
[6] 李志艳,刘 平,高 健,等.梅毒螺旋体抗体筛查方法的比较性研究[J].中华检验医学杂志,2012,35(12):1176-1179. Li ZY,Liu P,Gao J,et al.Comparative study of five analytical methords for screening of antibodies against treponema pallidun[J].Chinese Journal of Laboratory Medicine,2012,35(12):1176-1179.
[7] 郭慧娟,尚晓泓.微粒子化学发光法检测梅毒抗体阳性结果分析[J].检验医学与临床,2011,8(20):2444-2445. Guo HJ,Shang XH.The result analysis on the positive of syphilis treponema antibody by CMIA[J].Laboratory Medicine and Clinical,2011,8(20):2444-2445.
[8] 王柳溪.TP-ELISA法检测老年人梅毒抗体易产生假阳性原因分析[J].医学理论与实践,2008,21(9):1085-1086. Wang LX.The analysis the causes of false positive of TP-ELISA assay elderly syphilis[J].Medical Theory and Practice,2008,21(9):1085-1086.
[9] 廖朝晖,陈 民,黄进华,等.恶性肿瘤患者梅毒螺旋体抗体生物学假阳性分析[J].实用预防医学,2004,11(1):63-64. Liao ZH,Chen M,Huang JH,et al.Analysis of biologic false positive reactions of Treponema pallidum of the patients with malignant tumors[J].Practical Preventive Medicine,2004,11(1):63-64.
[10] 侯晓菁,梁 艳,陈 洁,等.化学发光法检测梅毒螺旋体特异性抗体的实验评价[J].检验医学,2010,25(5):365-367. Hou XJ,Liang Y,Chen J,et al.Experimental evaluation the of determination of specific antibodies to Treponema pallidum by chemiluminescent immunoassay [J].Laboratory Medicine,2010,25(5):365-367.

备注/Memo

备注/Memo:
作者简介:张保平(1965-),男,本科,主任检验师,从事临床免疫学检验,Tel:13948315416,E-mail:baoping7611@sina.com。 通讯作者:韩艳秋(1963-),女,博士,教授,硕士生导师,研究方向:临床血液学,Tel:0471-6637683,E-mail:qyh1016@sina.com。
更新日期/Last Update: 2015-03-20