潜伏结核感染检测在结核病诊断中的应用价值Meta分析
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摘要
目的通过Meta分析评价结核病皮肤试验(TST)相对QuantiFERON-TB(QFT)在不同免疫状态或不同判断标准下对潜伏结核感染(LTBI)的诊断效率,为口岸结核病诊断提供循证医学支持。方法检索PubMed、Elsevier、Science Direct、Springer Link、Wiley Online Library、中国知网、万方数据、维普数据库,检索时限为2004年1月1日至2017年12月31日。由两名研究员独立筛选检索结果,提取资料,并对纳入研究进行异质性检验。采用Meta-Disc 1.4软件进行系统评价。结果共纳入QFT与TST对LTBI的临床诊断试验41组,按免疫正常人群TST诊断标准5 mm、10 mm、15 mm及免疫抑制人群TST标准5 mm分为4个亚组。Meta分析结果显示,对于免疫正常人群,当TST的诊断标准选取5 mm或10 mm时,其诊断灵敏度较高;免疫抑制人群TST相对QFT的灵敏度低于免疫正常人群。结论对免疫正常的儿童、孕妇等不宜摄片人群若进行LTBI筛查,在无法开展QFT的场所,TST可作为一种经济便捷的检测手段,其阳性诊断标准宜选取5 mm或10 mm。对于免疫抑制患者,可考虑在胸片基础上加做LTBI筛查,尽量选用QFT等分子免疫学检测手段。
Objective To systematically review the diagnostic value of tuberculin skin test(TST) and QuantiFERON-TB(QFT)in latent tuberculosis infection(LTBI) under different immune status or cut-off points, in order to provide support for port tuberculosis diagnosis based on evidence-based medicine. Methods The following databases were searched from Jan 1 st 2004 to Dec 31 th 2017:Pub Med,Elsevier,Science Direct,Springer Link,Wiley Online Library,CNKI,WanFang data and CQVIP. Two researchers independently screened literatures,extracted data and assessed the heterogeneity. Meta-analysis was performed by using Meta-Disc 1.4 software. Results A total of 41 clinical diagnostic tests for LTBI diagnosis using QFT and TST were included. The result was divided into four sub-groups including immunocompetent group with TST cut-off point as 5 mm,10 mm and 15 mm and immunocompromised group with cut-off point as 5 mm. The result of Meta-analysis showed that the pooled sensitivity of TST in comparison with QFT was satisfying when using cut-off points of 5 mm or 10 mm among immunocompetent subjects.The sensitivity was lower in immunocompromised group than in immunocompetent group. Conclusion TST may be included in the port LTBI screening as an economical and efficient test when QFT is not available for immunocom-petent children and pregnant women who should not receive radiological examination. The cut-off point should be 5 mm or 10 mm. The LTBI test could be added to the regular chest radiological test for immunocompromised patients.Molecular immunological tests such as QFT are recommended.
Objective To systematically review the diagnostic value of tuberculin skin test(TST) and QuantiFERON-TB(QFT)in latent tuberculosis infection(LTBI) under different immune status or cut-off points, in order to provide support for port tuberculosis diagnosis based on evidence-based medicine. Methods The following databases were searched from Jan 1 st 2004 to Dec 31 th 2017:Pub Med,Elsevier,Science Direct,Springer Link,Wiley Online Library,CNKI,WanFang data and CQVIP. Two researchers independently screened literatures,extracted data and assessed the heterogeneity. Meta-analysis was performed by using Meta-Disc 1.4 software. Results A total of 41 clinical diagnostic tests for LTBI diagnosis using QFT and TST were included. The result was divided into four sub-groups including immunocompetent group with TST cut-off point as 5 mm,10 mm and 15 mm and immunocompromised group with cut-off point as 5 mm. The result of Meta-analysis showed that the pooled sensitivity of TST in comparison with QFT was satisfying when using cut-off points of 5 mm or 10 mm among immunocompetent subjects.The sensitivity was lower in immunocompromised group than in immunocompetent group. Conclusion TST may be included in the port LTBI screening as an economical and efficient test when QFT is not available for immunocom-petent children and pregnant women who should not receive radiological examination. The cut-off point should be 5 mm or 10 mm. The LTBI test could be added to the regular chest radiological test for immunocompromised patients.Molecular immunological tests such as QFT are recommended.
引文
[1] World Health Organization. Global tuberculosis report 2018[R/OL]. http://www.who.int/tb/publications/global_report/en/.
[2]国家质检总局.SN/T 1283-2012国境口岸结核病监测规程[S].北京:中国标准出版社,2012.
[3] U.S.CDC. Tuberculosis Technical Instructions for Panel Physicians[EB/OL].[2018-09-05]. https://www.cdc.gov/immigrantrefugeehealth/exams/ti/panel/tuberculosis-panel-technical-instructions.html#latent.
[4]国家卫生计生委.WS 288—2017中华人民共和国卫生行业标准肺结核诊断[S].北京:中国标准出版社,2017.
[5] Tissot F,Zanetti G,Francioli P,et al. Influence of Bacille Calmette-Guerin vaccination on size of tuberculin skin test reaction:To what size[J]. Clinical Infectious Diseases,2005(40):211-217.
[6] Diel R,Loddenkemper R,Nienhaus A. Evidence-based comparison of commercial interferon-γrelease assays for detecting active TB:A meta analysis[J].Chest,2010(137):952-968.
[7] Nobuyuki H,Kazue H,Yukie S,et al. Basic characteristics of a novel diagnostic method(QuantiFERON TB-2G)for latent tuberculosis infection with the use of mycobacterium tuberculosis-specific antigens,ESAT-6 and CFP-10[J]. Kekkaku,2004,79(12):725-735.
[8] Fleming J,England T,Wernick H,et al. Case-control study of firefighters with documented positive tuberculin skin test results using QuantiFERON-TB testing in comparison with firefighters with negative tuberculin skin test results[J]. Journal of Occupational Medicine and Toxicology,2006(1):28.
[9] Legesse M,Ameni G,Mamo G,et al. Community-based crosssectional survey of latent tuberculosis infection in Afar pastoralists,Ethiopia,using QuantiFERON-TB gold in-tube and tuberculin skin test[J].BMC Infectious Diseases,2011(11):89.
[10] Tieu H,Suntarattiwong P,Puthanakit T,et al. Comparing interferon-gamma release assays to tuberculin skin test in Thai children with tuberculosis exposure[J]. PLoS One,2014,9(8):e105003.
[11] Talebi-Taher M,Javad-Moosavi S,Entezari A,et al. Comparing the performance of QuantiFERON-TB gold and Mantoux test in detecting latent tuberculosis infection among Iranian health care workers[J]. International Journal of Occupational Medicine and Environmental Health,2011,24(4):359-366.
[12] Dogra S,Narang P,Mendiratta D,et al. Comparison of a whole blood interferon-γassay with tuberculin skin testing for the detection of tuberculosis infection in hospitalized children in rural India[J]. Journal of Infection,2007(54):267-276.
[13] Souza F,Prado T,Pinheiro J,et al. Comparison of interferon-γrelease assay to two cut-off points of tuberculin skin test to detect latent mycobacterium tuberculosis infection in primary health care workers[J]. PLoS One,2014,9(8):e102773.
[14] Franken W,Timmermans J,Prins C,et al. Comparison of Mantoux and QuantiFERON TB gold tests for diagnosis of latent tuberculosis infection in army personnel[J]. Clinical and Vaccine Immunology,2007,14(4):477-480.
[15] Vinton P,Mihrshahi S,Johnson P,et al. Comparison of QuantiFERON-TB gold in-tube test and tuberculin skin test for identification of latent mycobacterium tuberculosis infection in healthcare staff and association between positive test results and known risk factors for infection[J]. Infect Control Hosp Epidemiol,2009,30(3):215-221.
[16] Kobashi Y,Shimizu H,Ohue Y,et al. Comparison of T-cell interferon-γrelease assays for mycobacterium tuberculosis-specific antigens in patients with active and latent tuberculosis[J].Lung,2010(188):283-287.
[17] Song S,Yang J,Lee K,et al. Comparison of the tuberculin skin test and interferon gamma release assay for the screening of tuberculosis in adolescents in close contact with tuberculosis TB patients[J]. PLoS One,2014,9(7):e100267.
[18] Ozdemir D,Annakkaya A,Tarhan G,et al. Comparison of the tuberculin skin test and the QuantiFERON test for latent mycobacterium tuberculosis infections in health care workers in Turkey[J].Jpn J Infect Dis,2007(60):102-105.
[19] Mazurek G,Zajdowicz M,Hankinson A,et al. Detection of Mycobacterium tuberculosis infection in United States navy recruits using the tuberculin skin test or whole-blood interferon-γrelease assays[J]. Clinical Infectious Diseases,2007(45):826-836.
[20] Arend S,Thijsen F,Leyten E,et al. Comparison of two interferon-γassays and tuberculin skin test for tracing tuberculosis contacts[J]. Am J Respir Crit Care Med,2007(175):618-627.
[21] Jones-López E,White L,Kirenga B,et al. Cough aerosol cultures of Mycobacterium tuberculosis:Insights on TST/IGRA discordance and transmission dynamics[J]. PLoS One,2015,10(9):e0138358.
[22] Onur H,Hatipoglu S,Arica V,et al. Comparison of QuantiFERON test with tuberculin skin test for the detection of tuberculosis infection in children[J]. Inflammation,2012,35(4):1518-1524.
[23] Kobashi Y,Mouri K,Yagi S,et al. Clinical utility of the QuantiFERON TB-2G test for elderly patients with active tuberculosis[J].Chest,2008,133(5):1196-1202.
[24] Mahomed H,Hawkridge T,Verver S,et al. The tuberculin skin test versus QuantiFERON TB gold in predicting tuberculosis disease in an adolescent cohort study in South Africa[J]. PLoS One,2011,6(3):e17984.
[25] Bua A,Molicotti P,Cannas S,et al. Tuberculin skin test and QuantiFERON in children[J]. New Microbiologica,2013(36):153-156.
[26] Kashyap R,Nayak A,Gaherwar H,et al. Latent TB infection diagnosis in population exposed to TB subjects in close and poor ventilated high TB endemic zone in India[J]. PLoS,2014,9(3):e85924.
[27] Zhao X,Mazlagic D,Flynn E,et al. Is the QuantiFERON-TB blood assay a good replacement for the tuberculin skin test in tuberculosis screening?[J]. Am J Clin Pathol,2009,132:678-686.
[28] Balcells M,Perez C,Chanqueo L,et al. A comparative study of two different methods for the detection of latent tuberculosis in HIV-positive individuals in Chiles[J]. International Journal of Infectious Diseases,2008(12):645-652.
[29] Kwakernaak A,Houtman P,Weel J,et al. A comparison of an interferon-gamma release assay and tuberculosis skin test in refractory inflammatory disease patients screened for latent tuberculosis prior to the initiation of a first tumor necrosis factorαinhibitor[J]. Clin Rheumatol,2011(30):505-510.
[30] Souza J,Evangelista M,Trajman A. Added value of QuantiFERON TB-gold in-tube for detecting latent tuberculosis infection among persons living with HIV/AIDS[J]. BioMed Research International,2014:e294963.
[31] Hoffmann M,Tsinalis D,Vernazza P,et al. Assessment of an interferon-γrelease assay for the diagnosis of latent tuberculosis infection in haemodialysis patients[J]. Swiss Med Wkly,2010,140(19-20):286-292.
[32] Vassilopoulos D,Tsikrika S,Hatzara C,et al. Comparison of two gamma interferon release assays and tuberculin skin testing for tuberculosis screening in a cohort of patients with rheumatic diseases starting anti-tumor necrosis factor therapy[J]. Clinical and Vaccine Immunology,2011,18(12):2102-2108.
[2]国家质检总局.SN/T 1283-2012国境口岸结核病监测规程[S].北京:中国标准出版社,2012.
[3] U.S.CDC. Tuberculosis Technical Instructions for Panel Physicians[EB/OL].[2018-09-05]. https://www.cdc.gov/immigrantrefugeehealth/exams/ti/panel/tuberculosis-panel-technical-instructions.html#latent.
[4]国家卫生计生委.WS 288—2017中华人民共和国卫生行业标准肺结核诊断[S].北京:中国标准出版社,2017.
[5] Tissot F,Zanetti G,Francioli P,et al. Influence of Bacille Calmette-Guerin vaccination on size of tuberculin skin test reaction:To what size[J]. Clinical Infectious Diseases,2005(40):211-217.
[6] Diel R,Loddenkemper R,Nienhaus A. Evidence-based comparison of commercial interferon-γrelease assays for detecting active TB:A meta analysis[J].Chest,2010(137):952-968.
[7] Nobuyuki H,Kazue H,Yukie S,et al. Basic characteristics of a novel diagnostic method(QuantiFERON TB-2G)for latent tuberculosis infection with the use of mycobacterium tuberculosis-specific antigens,ESAT-6 and CFP-10[J]. Kekkaku,2004,79(12):725-735.
[8] Fleming J,England T,Wernick H,et al. Case-control study of firefighters with documented positive tuberculin skin test results using QuantiFERON-TB testing in comparison with firefighters with negative tuberculin skin test results[J]. Journal of Occupational Medicine and Toxicology,2006(1):28.
[9] Legesse M,Ameni G,Mamo G,et al. Community-based crosssectional survey of latent tuberculosis infection in Afar pastoralists,Ethiopia,using QuantiFERON-TB gold in-tube and tuberculin skin test[J].BMC Infectious Diseases,2011(11):89.
[10] Tieu H,Suntarattiwong P,Puthanakit T,et al. Comparing interferon-gamma release assays to tuberculin skin test in Thai children with tuberculosis exposure[J]. PLoS One,2014,9(8):e105003.
[11] Talebi-Taher M,Javad-Moosavi S,Entezari A,et al. Comparing the performance of QuantiFERON-TB gold and Mantoux test in detecting latent tuberculosis infection among Iranian health care workers[J]. International Journal of Occupational Medicine and Environmental Health,2011,24(4):359-366.
[12] Dogra S,Narang P,Mendiratta D,et al. Comparison of a whole blood interferon-γassay with tuberculin skin testing for the detection of tuberculosis infection in hospitalized children in rural India[J]. Journal of Infection,2007(54):267-276.
[13] Souza F,Prado T,Pinheiro J,et al. Comparison of interferon-γrelease assay to two cut-off points of tuberculin skin test to detect latent mycobacterium tuberculosis infection in primary health care workers[J]. PLoS One,2014,9(8):e102773.
[14] Franken W,Timmermans J,Prins C,et al. Comparison of Mantoux and QuantiFERON TB gold tests for diagnosis of latent tuberculosis infection in army personnel[J]. Clinical and Vaccine Immunology,2007,14(4):477-480.
[15] Vinton P,Mihrshahi S,Johnson P,et al. Comparison of QuantiFERON-TB gold in-tube test and tuberculin skin test for identification of latent mycobacterium tuberculosis infection in healthcare staff and association between positive test results and known risk factors for infection[J]. Infect Control Hosp Epidemiol,2009,30(3):215-221.
[16] Kobashi Y,Shimizu H,Ohue Y,et al. Comparison of T-cell interferon-γrelease assays for mycobacterium tuberculosis-specific antigens in patients with active and latent tuberculosis[J].Lung,2010(188):283-287.
[17] Song S,Yang J,Lee K,et al. Comparison of the tuberculin skin test and interferon gamma release assay for the screening of tuberculosis in adolescents in close contact with tuberculosis TB patients[J]. PLoS One,2014,9(7):e100267.
[18] Ozdemir D,Annakkaya A,Tarhan G,et al. Comparison of the tuberculin skin test and the QuantiFERON test for latent mycobacterium tuberculosis infections in health care workers in Turkey[J].Jpn J Infect Dis,2007(60):102-105.
[19] Mazurek G,Zajdowicz M,Hankinson A,et al. Detection of Mycobacterium tuberculosis infection in United States navy recruits using the tuberculin skin test or whole-blood interferon-γrelease assays[J]. Clinical Infectious Diseases,2007(45):826-836.
[20] Arend S,Thijsen F,Leyten E,et al. Comparison of two interferon-γassays and tuberculin skin test for tracing tuberculosis contacts[J]. Am J Respir Crit Care Med,2007(175):618-627.
[21] Jones-López E,White L,Kirenga B,et al. Cough aerosol cultures of Mycobacterium tuberculosis:Insights on TST/IGRA discordance and transmission dynamics[J]. PLoS One,2015,10(9):e0138358.
[22] Onur H,Hatipoglu S,Arica V,et al. Comparison of QuantiFERON test with tuberculin skin test for the detection of tuberculosis infection in children[J]. Inflammation,2012,35(4):1518-1524.
[23] Kobashi Y,Mouri K,Yagi S,et al. Clinical utility of the QuantiFERON TB-2G test for elderly patients with active tuberculosis[J].Chest,2008,133(5):1196-1202.
[24] Mahomed H,Hawkridge T,Verver S,et al. The tuberculin skin test versus QuantiFERON TB gold in predicting tuberculosis disease in an adolescent cohort study in South Africa[J]. PLoS One,2011,6(3):e17984.
[25] Bua A,Molicotti P,Cannas S,et al. Tuberculin skin test and QuantiFERON in children[J]. New Microbiologica,2013(36):153-156.
[26] Kashyap R,Nayak A,Gaherwar H,et al. Latent TB infection diagnosis in population exposed to TB subjects in close and poor ventilated high TB endemic zone in India[J]. PLoS,2014,9(3):e85924.
[27] Zhao X,Mazlagic D,Flynn E,et al. Is the QuantiFERON-TB blood assay a good replacement for the tuberculin skin test in tuberculosis screening?[J]. Am J Clin Pathol,2009,132:678-686.
[28] Balcells M,Perez C,Chanqueo L,et al. A comparative study of two different methods for the detection of latent tuberculosis in HIV-positive individuals in Chiles[J]. International Journal of Infectious Diseases,2008(12):645-652.
[29] Kwakernaak A,Houtman P,Weel J,et al. A comparison of an interferon-gamma release assay and tuberculosis skin test in refractory inflammatory disease patients screened for latent tuberculosis prior to the initiation of a first tumor necrosis factorαinhibitor[J]. Clin Rheumatol,2011(30):505-510.
[30] Souza J,Evangelista M,Trajman A. Added value of QuantiFERON TB-gold in-tube for detecting latent tuberculosis infection among persons living with HIV/AIDS[J]. BioMed Research International,2014:e294963.
[31] Hoffmann M,Tsinalis D,Vernazza P,et al. Assessment of an interferon-γrelease assay for the diagnosis of latent tuberculosis infection in haemodialysis patients[J]. Swiss Med Wkly,2010,140(19-20):286-292.
[32] Vassilopoulos D,Tsikrika S,Hatzara C,et al. Comparison of two gamma interferon release assays and tuberculin skin testing for tuberculosis screening in a cohort of patients with rheumatic diseases starting anti-tumor necrosis factor therapy[J]. Clinical and Vaccine Immunology,2011,18(12):2102-2108.