Meta分析评价AMPLICOR检测系统对结核病的诊断价值

摘要/Abstract

摘要： 目的用Meta分析综合评价AMPLICOR检测系统对结核病的诊断价值。方法搜索Medline数据库,检索用AMPLICROR检测系统诊断结核病的文献,摘录相关数据。数据分析用Sigmaplot软件绘制SROC曲线,用Cochrane工作组的Revman4．2软件进行Meta分析,用非参数检验比较不同金标准和不同标本类型对结果的影响。结果共获得到文献42篇,AMPLICOR检测系统诊断结核病敏感性81．2％,特异性96．0％,22篇文献分别分析了AMPLICOR检测系统对涂片阳性和阴性结果的差异,对涂片阳性病例敏感性97．0％,特异性76．6％,涂片阴性病例敏感性62．2％,特异性99．3％,采用不同金标准和不同标本类型DOR(Diagnostic Odd Ratio)有显著差异。结论AMPLICROR检测系统不仅对菌阳结核病,对菌阴结核病也具有一定诊断价值。影响试验结果的因素包括金标准的类型、菌阳标本所占比例、呼吸道标本所占比例等。

关键词: Meta分析, AMPLICOR, 结核, 诊断

Abstract: Objective To evaluate the value of AMPLICOR test in the diagnosis of tuberculosis by meta analysis. Methods We searched Medline database and screened the papers related to diagnosis of tuberculosis by AM-PLICOR test, and then drew the summary receiver operating characteristic(SROC)by Sigmaplot, and analyzed data by Revman 4.2(a software from Cochrane). Finally, we compared DOR(Diagnostic Odd Ratio) of different golden standard and different sample types by nonparametric test. Results The data from 42 papers were analyzed. It showed that the sensitivity and specificity of AMPLICOR test were 81.2% and 96.0% , respectively. Tweenty-two papers were analyzed on the sensitivity and specificity of AMPLICOR test for smear-positive cases (sensitivity 97%, specificity 76.6% )and smear-negative cases(sensitivity 62.2% , specificity 99.3%). There were significant difference of DOR on using different golden standard and different sample types. Conclusion AMPLICOR test might be useful for the diagnoses of the smear-positive tuberculosis and smear-negative tuberculosis.

Key words: Meta analysis, AMPLICOR test, Tuberculosis, Diagnosis

段鸿飞,傅瑜,李琦,马玙,. Meta分析评价AMPLICOR检测系统对结核病的诊断价值[J]. 中国防痨杂志, 2007, 29(1): 56-60.

Duan Hongfei, Fu Yu , Li Qi ,et al.. Evaluation of AMPLICOR Test in diagnosis of tuberculosis by Meta analysis[J]. Chinese Journal of Antituberculosis, 2007, 29(1): 56-60.

参考文献

1 Rapid diagnostic tests for tuberculosis ： what is the appropriate use?American Thoracic Society Workshop [J] . Am J Respir Crit Care Med,1997,155(5)： 1804-14
2 方积乾，陆盈.诊断试验的Mela分析//方积乾，陆盈.现代医学统计学[M].北京：人民卫生出版社,2002:182-195
3 Reischl U, Lehn N, Wolf H,et al. Clinical evaluation of the automated COBAS AMPLICOR MTB assay for testing respiratory and nonrespiratory specimens[J] .J Clin Microbiol, 1998 ,36(10) : 2853-60
4 Shah S, Miller A, Mastellone A, et al. Rapid diagnosis of tuberculosis in various biopsy and body fluid specimens by the AMPLICOR Mycobacterium tuberculosis polymerase chain reaction test[J] . Chest. 1998，113(5)：1190-1194
5 Lim TK，Mukhopadhyay A，Gough A , et al. Kole of clinical judgment in the application of a nucleic acid amplification test for the rapid diagnosis of pulmonary tuberculosis[J] . Chest ,2003 ,124(3) :902-908
6 Shim TS，Chi HS, Lee SD, et al. Adequately washed bronchoscope does not induce false-positive amplification tests on bronchial aspirates in the diagnosis of pulmonary luberculosis[J] . Chest,2002,121(3) :774-781
7 Honore-Buuakline S, Vincensini JP, Giacuzzo V, ea al. Rapid diagnosis of extrapulmonary tuberculosis by PCR: impact of sample preparation and DNA extraetion[J].J Clin Microbiol ,2003 ,41(6):2323-2329
8 Boddinghaus B, Wichelhaus TA, Brade V, et al. Removal of PCR inhibitors by silica membranes: evaluating the Amplicor Mycobacterium tuberculosis kit[J] .J Clin Microbiol, 2001,39(10):3750-3752
9 D' Amato RF, Wallman AA, Hochstein LH, et al. Rapid diagnosis of pulmonary tuberculosis by using Roche AMPLICOR Mycobacterium tuberculosis PCR test[J].J Clin Microbiol, 1995,33(7):1832-1834
10 Vuorinen P, Miettinen A, Vuento R, et al. Direct detection of Mycobacterium tuberculosis complex in respiratory specimens by Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test and Roche Amplicor Mycobacterium Tuberculosis Test[J] .J Clin Microbiol, 1995，33(7):1856-1859
11 Moore DF, Curry JI. Detection and identification of Mycobacterium tuberculosis directly from sputum sediments by Amplicor PCR[J] .J Clin Microbiol ,1995,33(10)：2686-2691
12 Carpentier E, Drouillard B，Dailloux M, et al. Diagnosis of tuberculosis by Amplicor Mycobacterium tuberculosis test: a multicenter study [J] . J Clin Microbiol，1995,33(12):3106-3110
13 lchiyama S, Iinuma Y, Tawada Y，et al. Evaluation of Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test and Roche PCR-miorow-ell plate hybridization method (AMPLICOR MYCOBACTERIUM) for direct detection of mycobacteria[J] . J Clin Microbiol, 1996,34(1)：130-133
14 Schirm J，Oostendorp LA, Mulder JG. Comparison of Amplicor, in-house PCR, and conventional culture for detection of Mycobacterium tuberculosis in clinical samples[J] .J Clin Microbiol, 1995 ,33(12) ：3221-3224
15 Wobeser WL, Krajden M , Conly J, et al. Evaluation of Roche Amplicor PCR assay for Mycobacterium tuberculosis[J] . J Clin Microbiol, 1996,34(1):134-139
16 Devallois A, Legrand E, Rastogi N. Evaluation of Amplicor MTB test as adjunct to smears and culture for direct detection of Mycobacterium tuberculosis in the French Caribbean[J]. J Clin Microbiol, 1996,34(5)：1065-1068
17 Bergmann JS, Woods GL. Clinical evaluation of the Roche AMPLICOR PCR Mycobacterium tuberculosis test for detection of M. tuberculosis in respiratory specimens[J] .J Clin Microbiol, 1996,34(5):1083-1085
18 Bennedsen J, Thomsen VO, Pfyffer GE，et al. Utility of PCR in diagnosing pulmonary tuberculosis[J].J Clin Microbiol, 1996，34(6):1407-1411
19 Soini H, Agha SA, EI-Fiky A, et al. Comparison of amplicor and 32-kilodalton PCR for detection of Mycobacterium tuberculosis from sputum specimens[J].J Clin Microbiol, 1996,34(7):1829-1830
20 Cartuyvels R, De Ridder C，Jonckheere S, et al. Prospective clinical evaluation of Amplicor Mycobacterium tuberculosis PCR test as a screening method in a low-prevalence population[J].J Clin Microbiol, 1996,34(8)： 2001-2003
21 Huang TS, Liu YC, Lin HH, et al. Comparison of the Roche AMPLICOR MYCOBACTERIUM assay and Digene SHARP Signal System with in-house PCR and culture for detection of Mycobacterium tuberculosis in respiratory specimens[J] . J Clin Microbiol, 1996,34(12) ： 3092-3096
22 Yuen KY, Yam WC, Wong LP, et al. Comparison of two automated DNA amplification systems with a manual one-lube nested PCR assay for diagnosis of pulmonary tuberculosis [J] . J Clin Microbiol, 1997,35(6):1385-1389
23 lchiyama S, Ito Y, Sugiura F, et al. Diagnostic value of the strand displacement amplification method compared to those of Roche Amplicor PCR and culture for detecting mycobacteria in sputum samples[J].J Clin Microbiol, 1997,35(12) ：3082-3085
24 Roscnstraus M, Wang Z, Chang SY，et al. An internal control for routine diagnostic PCR: design, properties, and effect on clinical performance[J].J Clin Microbiol, 1998,36(1)：191-197
25 Eing BR, Becker A , Sohns A , et al. Comparison of Koche Cobas Amplicor Mycobacterium tuberculosis assay with in-house PCR and culture for detection of M . tuberculosis[ J]. J Clin Microbiol, 1998,36(7) :2023-3029
26 Levidiotou S, Vrioni G, Gulanakis E, et al. Four-year experience of use of the Cobas Amplicor system for rapid detection of Mycobacterium tuberculosis complex in respiratory and nonrespiratory specimens in Greece[J] .Eur J Clin Microbiol Infect Dis, 2003 ,22(6) ：349-356
27 Gamboa F，Manterola JM, Lonca J，et al. Comparative evaluation of two commercial assays for direct detection of Mycobacterium tuberculosis in respiratory specimens[J].Eur J Clin Microbiol Infect Dis, 1998,17(3):151-157
28 Mitarai S, Tanoue S, Sugita C，et al. Potential use of Amplicor PCR kit in diagnosing pulmonary tuberculosis from gastric aspirate[J].J Microbiol Methods,2001，47(3)：339-344
29 Oh EJ，Park YJ, Chang CL, et al. Improved detection and differentiation of mycobacteria with combination of Mycobaclerium Growth Indicator Tube and Koche COBAS AMPLICOK System in conjunction with Duplex PCR[J].J Microbiol Methods, 2001,30,46(1) ：29-36
30 Tortoli E, Tronci M, Tosi CP, et al. Multicenter evaluation of two commercial amplification kits ( Amplicor, Koche and LCx, Abbott) for direct detection of Mycobacterium tuberculosis in pulmonary and extrapul-monary specimens[J]. Diagn Microbiol Infect Dis, 1999,33(3): 173-179
31 Se Thoe SY，Tay L, Sng EH. Evaluation of Amplicor-and IS6110-PCR for direct detection of Mycobacterium tuberculosis complex in Singapore[J] .Trop Med Int Health, 1997；2(11)：1095-1101
32 Iinuma Y, Senda K, Fujihara N，et al. Comparison of the BDProbeTec ET system with the Cobas Amplicor PCR for direct detection of Mycobacterium tuberculosis in respiratory samples[J]. Eur J Clin Microbiol Infect Dis,2003,22(6):368-371
33 Kim SY，Park YJ, Kang SJ, et al. Comparison of the BDProbeTec ET system with the roche COBAS AMPLICOR System for detection of Mycobacterium tuberculosis complex in the respiratory and pleural fluid specimens[J] . Diagn Microbiol Infect Dis,2004,49(1) ：13-18
34 Smith MB，Bergmann JS, Harris SL, et al. Evaluation of the Roche AMPLICOR MTB assay for the detection of Mycobacterium tuberculosis in sputum specimens from prison inmates [J].Diagn Microbiol Infect Dis,1997,27(4):113-116
35 Bogard M，Vincelelle J, Antinozzi R, et al. Multicenter study of a commercial ,automated polymerase chain reaction system for the rapid deleclion of Mycobacterium tubrrculosis in respiratory specimens in routine clinical practice[J]. Eur J Clin Microbiol Infect Dis,2001，20(10) :724-731
36 Mitarai S, Kurashima A, Tamura A, et al. Clinical evaluation of Amplicor Mycobacterium detection system for the diagnosis of pulmonary mycobacterial infection using sputum [J].Tuberculosis, 2001 ,81(5-6):319-325
37 Gomez-Pastrana D, Torronteras R，Caro P, et al. Comparison of amplicor, in-house polymerase chain reaction, and conventional culture for the diagnosis of tuberculosis in children [J].Clin Infect Dis, 2001, 32(1):17-22
38 Dalovisio JR, Montenegro-James S, Kemmerly SA, et al. Comparison of the amplified Mycobacterium tuberculosis (MTB) direct lest, Amplicor MTB PCR, and IS6110-PCR for detection of MTB in respiratory specimens[J].Clin Infect Dis, 1996,23(5):1099-1106
39 Della-I-atta P，Whittier S. Comprehensive evaluation of performance,laboratory application, and clinical usefulness of two direct amplification technologies for the detection of Mycobacterium tuberculosis complex[J].Am J Clin Pathol,1998,110(3):301-310
40 Shibuya Y, Shiozaki T, Hayashi M, et al.Efficacy of Amplicor PCR for the diagnosis of tuberculosis in respiratory specimens other than sputum[J]. Tuber Lung Dis. 2000,80(4-5):209-215
41 Stauffer F，Mulschlechner R, Hasenberger P, et al. Detection of Mycobacterium tuberculosis complex in clinical specimens by a commercial polymerase chain reaction kit[J].Eur J Clin Microbiol Infect Dis, 1995,14(12): 1046-1051
42 Zolnir-Dovc M, Poljak M，Seme K, et al. Evaluation of two commercial amplification assays for detection of Mycobacterium tuberculosis complex in respiratory specimens[J] . Infection, 1995,23(4) ：216-221
43 Jonsson B, Ridell M . The Cobas Amplicor MTB test for detection of Mycobaclerium tuberculosis complex from respiratory and non-respiratory clinical specimens[J]. Scand J Infect Dis,2003 ,35(6-7) ：372-377
44 Iinuma Y，lchiyama S, Yamori S, et al. Diagnostic value of the Amplicor PCH assay for initial diagnosis and assessment of I raiment response for pulmonary tuberculosis[J]. Microbiol Immunol, 1998 ,42(4)：281-287

[1]	刘晓莉, 雷丽梅, 郭周莉, 黄殷, 徐静, 赵霞, 王燕, 付莉. 结核病患者产生病耻感与领悟社会支持的相关性研究[J]. 中国防痨杂志, 2020, 42(9): 1002-1008.
[2]	中国防痨协会学术工作委员会《中国防痨杂志》编辑委员会. 抗结核药品固定剂量复合制剂的临床使用专家共识[J]. 中国防痨杂志, 2020, 42(9): 885-893.
[3]	靳鸿建. 我国县级结核病防治服务体系建设及防治工作亟需加强——一位老防痨工作者的意见和建议[J]. 中国防痨杂志, 2020, 42(9): 896-902.
[4]	张灿有, 夏辉, 成君. Ⅱ级生物安全柜在结核病实验室中的检测及报告要求[J]. 中国防痨杂志, 2020, 42(9): 903-909.
[5]	周林, 刘二勇, 孟庆琳, 陈明亭, 周新华, 高微微, 林明贵, 谢汝明. 《WS 288—2017 肺结核诊断》标准实施后肺结核诊断质量评估分析[J]. 中国防痨杂志, 2020, 42(9): 910-915.
[6]	刘二勇, 王前, 周林, 张国钦, 张修磊, 马永成, 杨枢敏, 王毳, 孟庆琳, 陈明亭, 林明贵, 屠德华. 我国部分地区病原学检测阴性肺结核诊断质量现状分析[J]. 中国防痨杂志, 2020, 42(9): 916-920.
[7]	孟庆琳, 李进岚, 林定文, 马永成, 侯双翼, 刘年强, 周林. 结核病防治从业人员对新的结核病标准相关知识知晓情况调查分析[J]. 中国防痨杂志, 2020, 42(9): 921-925.
[8]	王前, 周林, 刘二勇, 赵雁林, 李涛, 陈明亭, 杨丽佳, 王嘉. 我国县级结核病定点医疗机构结核病诊断能力现况调查研究[J]. 中国防痨杂志, 2020, 42(9): 926-930.
[9]	李婷, 何金戈, 苏茜, 李京, 李运葵, 高文凤, 高媛, 杨文. 结核菌素试验在四川省布拖县HIV感染/AIDS患者中筛查结核感染的价值[J]. 中国防痨杂志, 2020, 42(9): 931-936.
[10]	李运葵, 何金戈, 苏茜, 李婷, 李京, 高文凤, 杨文, 毛光玉. 结核病症状筛查在四川省布拖县HIV感染/AIDS患者中发现结核病患者的价值[J]. 中国防痨杂志, 2020, 42(9): 937-941.
[11]	苏茜, 夏勇, 逯嘉, 王丹霞, 何金戈. 2009—2018年四川省0~14 岁儿童肺结核流行特征分析[J]. 中国防痨杂志, 2020, 42(9): 942-947.
[12]	邓亚丽, 张天华, 刘卫平, 张宏伟, 马煜, 李鹏. 2014—2018年陕西省肺结核发病的时空聚集性分析[J]. 中国防痨杂志, 2020, 42(9): 948-955.
[13]	董晓, 赵珍, 刘年强, 王森路, 崔燕. 2009—2017年新疆维吾尔自治区老年肺结核发现特征分析[J]. 中国防痨杂志, 2020, 42(9): 956-961.
[14]	梁瑞云, 方伟军, 任会丽, 黎惠如, 张晖. 非结核分枝杆菌肺病并发与未并发糖尿病患者的CT征象研究[J]. 中国防痨杂志, 2020, 42(9): 962-967.
[15]	马廷龙, 韩毅, 程序, 刘志东. 超声抗结核药品电导入联合化疗对胸壁结核的疗效观察[J]. 中国防痨杂志, 2020, 42(9): 968-972.