Application value of detecting Mycobacterium tuberculosis specific IgG/IgM antibodies for tuberculosis diagnosis with colloidal gold immunochromatography assay
LI Shuang-jun1, 2, ZHANG Zhi-guo3, YU Qin4, LUO Qiao1, 2, WANG Li3, LI Xiao-qin1, 2, LI Ma-chao2, LIU Hai-can2, WAN Kang-lin1, 2
1. School of Laboratory Medicine and Life Science, Wenzhou Medical University, Wenzhou 325035, China; 2. State Key Laboratory for Communicable Disease Control and Prevention, Institute for Communicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing 102206, China; 3. The Institute of Tuberculosis Prevention and Control of Changping District, Beijing 102200, China; 4. Beijing Chaoyang District Center for Disease Control and Prevention, Beijing 100021, China
Abstract：In this study, we estimated the application value of detecting Mycobacterium tuberculosis (MTB) specific IgG/IgM antibodies for tuberculosis diagnosis with colloidal gold immunochromatography assay (GICA). We collected 332 effective serum samples and their background information, including 260 patients with tuberculosis and 72 healthy individuals. The means of GICA was used to detect MTB specific IgG/IgM antibodies. Results were compared with the clinical diagnosis and the results of bacteriological tests. The SPSS 22.0 software was used to analyze the results, and when P<0.05 the difference was statistically significant. The sensitivity and specificity of GICA were 41.15% and 91.67%, and the sensitivity of the bacterial positive and negative patients were 51.38% and 33.77%, respectively. The positive rate of IgG/IgM antibodies detection with GICA (41.15%) was much higher than that of bacteria with acid-fast stain of sputum smear (18.84%) and sputum bacteria cultivation (36.15%) (P<0.05) respectively. The positive rate of the combination of tuberculosis antibody detection, sputum bacterial culture and sputum smear was 61.54%, higher than the result of single method or combination of two methods. The detection of specific antibodies against MTB in serum with GICA is sensitive, specific, rapid and convenient, which can be used in clinical screening. Meanwhile, there are still certain limitations of this method, and the sensitivity and specificity need to be improved. Therefore, the GICA can be used as an auxiliary diagnosis combined with sputum bacteriology,imaging test and clinical features rather than diagnose tuberculosis alone.
李霜君, 张治国, 余琴, 罗巧, 王莉, 李晓琴, 李马超, 刘海灿, 万康林. 胶体金免疫层析法检测结核分枝杆菌特异性IgG/IgM抗体对结核病诊断的应用价值[J]. 中国人兽共患病学报, 2018, 34(2): 139-144.
LI Shuang-jun, ZHANG Zhi-guo, YU Qin, LUO Qiao, WANG Li, LI Xiao-qin, LI Ma-chao, LIU Hai-can, WAN Kang-lin. Application value of detecting Mycobacterium tuberculosis specific IgG/IgM antibodies for tuberculosis diagnosis with colloidal gold immunochromatography assay. Chinese Journal of Zoonoses, 2018, 34(2): 139-144.
[1] WHO. Global tuberculosis report 2017[M]. Geneva: World Health Organisation, 2017. [2] Wang CY, Li YR. The analyses of 3479 sputum specimens of acid-fast bacillus of pulmonary tuberculosis patients[J]. J Clin Pulmon Med, 2004, 9(6): 605-606. (in Chinese) 王成勇, 李益荣. 3 479例肺结核病人痰标本抗酸杆菌检查结果分析[J]. 临床肺科杂志, 2004, 9(6): 605-606. [3] Steingart KR, Ramsay A, Pai M. Optimizing sputum smear microscopy for the diagnosis of pulmonary tuberculosis[J]. Expert Rev Anti Infect Ther, 2007, 5(3): 327-331. doi:10.1586/14787210.5.3.327 [4] Small PM, Pai M. Tuberculosis diagnosis-time for a game change[J]. N Engl J Med, 2010, 363(11): 1070-1071. doi:10.1056/NEJMe1008496 [5] Mancuso JD, Mody RM, Olsen CH, et al. The long-term effect of Bacille Calmette-Guerin vaccination on tuberculin skin testing: a 55-year follow-up study[J]. Chest, 2017, 142(3): 761-773. doi:10.1016/j.chest.2017.01.001 [6] Abe C, Hirano K, Wada M, et al. Detection of Mycobacterium tuberculosis in clinical specimens by polymerase chain reaction and gen-probe amplified Mycobacterium Tuberculosis direct test[J]. J Clin Microbiol, 1993, 31(12): 3270-3274. [7] Helb D, Jones M, Story E, et al. Rapid detection of Mycobacterium tuberculosis and rifampin resistance by use of on-demand, near-patient technology[J]. J Clin Microbiol, 2010, 48(1): 229-237. doi:10.1128/JCM.01463-09 [8] Guo Y, Zhou Y, Wang C, et al. Rapid, accurate determination of multidrug resistance in M. tuberculosis isolates and sputum using a biochip system[J]. Int J Tuberc Lung Dis, 2009, 13(7): 914-920. [9] Ruhwald M, Aggerbeck H, Gallardo RV, et al. Safety and efficacy of the C-Tb skin test to diagnose Mycobacterium tuberculosis infection, compared with an interferon gamma release assay and the tuberculin skin test: a phase 3, double-blind, randomised, controlled trial[J]. Lancet Respir Med, 2017, 5(4): 259-268. doi:10.1016/S2213-2600(16)30436-2 [10] El-Samadony H, Althani A, Tageldin MA, et al. Nanodiagnostics for tuberculosis detection[J]. Expert Rev Mol Diagn, 2017, 17(5): 427-443. doi:10.1080/14737159.2017.1308825 [11] Wang SM, Zhu JH, Zhang LX. Clinical laboratory procedures for tuberculosis diagnosis[M]. Beijing: Chinese Education and Culture Publishing House, 2006: 13-51. (in Chinese) 王甦民,朱建华,张立兴. 结核病诊断实验室检验规程[M]. 北京: 中国教育文化出版社, 2006:13-51. [12] Feng X, Xiu B, Chen K, et al. Enhanced serodiagnostic utility of novel Mycobacterium tuberculosis polyproteins[J]. J Infect, 2013, 66(4): 366-375. doi:10.1016/j.jinf.2012.10.029 [13] Sumi MG, Mathai A, Reuben S, et al. A comparative evaluation of dot immunobinding assay (Dot-Iba) and polymerase chain reaction (PCR) for the laboratory diagnosis of tuberculous meningitis[J]. Diagn Microbiol Infect Dis, 2002, 42(1): 35-38. [14] Demissie A, Leyten EM, Abebe M, et al. Recognition of stage-specific mycobacterial antigens differentiates between acute and latent infections with Mycobacterium tuberculosis [J]. Clin Vaccine Immunol, 2006, 13(2): 179-186. doi:10.1128/CVI.13.2.179-186.2006 [15] Imaz MS, Comini MA, Zerbini E, et al. Evaluation of commercial enzyme-linked immunosorbent assay kits for detection of tuberculosis in Argentinean population[J]. J Clin Microbiol, 2004, 42(2): 884-887. [16] Mathai E, Rajkumari R, Kuruvilla PJ, et al. Evaluation of serological tests for the diagnosis of tuberculosis[J]. Indian J Pathol Microbiol, 2002, 45(3): 303-305. [17] Xia Q, Fu CC, Zhu ZJ, et al. IgG and IgM antibodies detection for pulmonary and extrapulmonary tuberculosis diagnosis[J]. Chin J Zoonoses, 2014, 30(10): 1052-1056. (in Chinese) 夏强, 傅潺潺, 竺祖军, 等. 结核抗体lgG/lgM检测在肺结核和肺外结核中的诊断价值[J]. 中国人兽共患病学报, 2014, 30(10): 1052-1056. [18] Bothamley GH. Serological diagnosis of tuberculosis[J]. Eur Respir J Suppl, 1995, 20: 676s-688s. [19] Li LY. The value of serum tuberculosis antibody detection for tuberculosis diagnosis[J]. Int J Lab Med, 2009, 30(12): 1217-1218. (in Chinese) 李琳芸. 血清结核分支杆菌抗体检测对结核病的诊断价值探讨[J]. 国际检验医学杂志, 2009, 30(12): 1217-1218. [20] Chiang IH, Suo J, Bai KJ, et al. Serodiagnosis of tuberculosis. A study comparing three specific mycobacterial antigens[J]. Am J Respir Crit Care Med, 1997, 156(3 Pt 1): 906-911. doi:10.1164/ajrccm.156.3.9607122 [21] Daniel TM, Debanne SM. The serodiagnosis of tuberculosis and other mycobacterial diseases by enzyme-linked immunosorbent assay[J]. Am Rev Respir Dis, 1987, 135(5): 1137-1151. doi:10.1164/arrd.1987.135.5.1137 [22] Technical Guidance Group of the Fifth National TB Epidemiological Survey, The Office of the Fifth National TB Epidemiological Survey. The fifth national tuberculosis epidemiological survey in 2010[J]. Chin J antitubercul, 2012, 34(8): 485-508. (in Chinese) 全国第五次结核病流行病学抽样调查技术指导组, 全国第五次结核病流行病学抽样调查办公室. 2010年全国第五次结核病流行病学抽样调查报告[J]. 中国防痨杂志, 2012, 34(8): 485-508. [23] Steingart KR, Henry M, Laal S, et al. Commercial serological antibody detection tests for the diagnosis of pulmonary tuberculosis: a systematic review[J]. PLoS Med, 2007, 4(6): e202. doi:10.1371/journal.pmed.0040202 [24] WHO. Diagnosis evaluation series No.2: laboratory-based evaluation of 19 commercially available rapid diagnostic tests for tuberculosis, [2008-10-10]. http://www.who.int/tdr/publications/tdr-research-publications/diagnostics-evaluation-2/en/
2018, Vol. 34 
