Diagnostic performance and problem analysis of commercial tuberculosis antibody detection kits in China

Xue-Juan Bai; You-Rong Yang; Jian-Qin Liang; Hui-Ru An; Jie Wang; Yan-Bo Ling; Zhong-Yuan Wang; Xue-Qiong Wu

doi:10.1186/s40779-018-0157-6

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Diagnostic performance and problem analysis of commercial tuberculosis antibody detection kits in China

RESEARCH | Updated：2026-03-12

- Diagnostic performance and problem analysis of commercial tuberculosis antibody detection kits in China
- Military Medical Research Vol. 5, Issue 3, Pages: 242-250(2018)
- Affiliations：
  
  1.Army Tuberculosis Prevention and Control Key Laboratory, Beijing Key Laboratory of New Techniques of Tuberculosis Diagnosis and Treatment, Institute of Tuberculosis Research, 309 Hospital of Chinese PLA, Beijing 100091, China
  2.Tuberculosis Department No.1. Institute of Tuberculosis Research, 309 hospital of Chinese PLA, Beijing 100091, China
  3.Tuberculosis Department No.2. Institute of Tuberculosis Research, 309 hospital of Chinese PLA, Beijing 100091, China
  4.Tuberculosis Department No.3, Institute of Tuberculosis Research309 Hospital of Chinese PLA, Beijing 100091, China
- Author bio：
  
  *: wzy2004177@sina.com;
  wu-xueqiong@263.net
- Funds：
- DOI：10.1186/s40779-018-0157-6
  CLC：
- Published：2018-09
- Accepted：
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Bai et al.: Diagnostic performance and problem analysis of commercial tuberculosis antibody detection kits in China. Mil Med Res, 2018, 5: 10
DOI：

Bai et al.: Diagnostic performance and problem analysis of commercial tuberculosis antibody detection kits in China. Mil Med Res, 2018, 5: 10 DOI： 10.1186/s40779-018-0157-6.

摘要

Abstract

Background:

The diagnosis of bacterium-negative pulmonary tuberculosis (TB) and extra-pulmonary TB is challenging clinically. The detection of the anti-TB antibody has an important

auxiliary

clinical diagnostic value. Therefore

TB antibody detection kits should be screened and evaluated

and the reagents with the highest sensitivity and specificity should be chosen and used clinically.

Methods:

The diagnostic performance of 7 commercially available TB antibody detection kits (kits A

F and G) based on the gold immunoassay detection of immunoglobulin (Ig) G or IgM antibodies were simultaneously evaluated and compared in 62 TB cases and 56 non-TB cases in a laboratory. A retrospective analysis including 2549 cases was carried out to assess the clinical diagnosis values of bacteriological examinations and TB antibody tests (kits B and H used in the clinic).

Results:

The sensitivities of TB antibody kits A

F and G in the sera from 62 TB patients were 50.0%

83.9%

38.7%

9.7%

48.4%

69.4% and 79.0%

respectively; the sensitivities in the sera from 24 smear-negative TB patients were 29.2%

79.2%

29.2%

12.5%

29.2%

54.2% and 79.2%

respectively; the specificities in the sera from 56 non-TB patients were 73.2%

25.0%

85.7%

96.4%

78.6%

78.6% and 50.0%

respectively. Of the 2549 clinically diagnosed cases

there were 1752 pulmonary TB cases

505 extra-pulmonary TB cases

87 old pulmonary TB cases and 205 non-TB cases. The positive results for smear

culture

TB antibody kit B and kit H in pulmonary TB cases were 39.8%(543/1365)

48.6%(372/765)

45.8%(802/1752) and 25.2%(442/1752)

respectively; the results in extra-pulmonary TB cases were 3.4%(6/178)

5.8%(4/69)

35.4% (179/505)

and 11.3%(57/505)

respectively; the results in old pulmonary TB cases were 0%(0/64)

0%(0/30)

32.2%(28/87)

and 9.2%(8/87)

respectively; and the results in non-TB cases were 0%(0/121)

0%(0/56)

21.5%(44/205)

and 2.4%(5/205)

respectively. Of 624 smear-positive and/or culture-positive pulmonary TB cases

the sensitivities of antibody test kits B and H were 53.0% and 36.4%

respectively. Of 901 smear-negative and/or culture-negative pulmonary TB cases

the sensitivities of antibody test kits B and H were 42.5% and 19.0%

respectively. The positive rate of antibody detection in the bacterium-positive pulmonary TB cases was significantly higher than that in the bacterium-negative pulmonary TB cases (P<0.05).

Conclusion:

The colloidal gold-labeled TB antibody IgG detection assay is a simple

rapid and economical method that provides a better clinical auxiliary diagnosis value on TB

especially in smear-negative pulmonary TB and extrapulmonary TB. The production

quality control

screening and evaluation of antibody detection kits are very important for its clinical application.

关键词

Keywords

references

World Health Organization . Global tuberculosis report 2016 . http://www.tbonline.info/posts/2016/10/16/global-tb-report-2016/ http://www.tbonline.info/posts/2016/10/16/global-tb-report-2016/ .

National Technic Steering Group of the Epidemiological Sampling Survey for Tuberculosis . Report on fifth National Epidemiological Sampling Survey of tuberculosis . Chin J Antituberc (in Chinese) . 2012 ; 34 ( 8 ): 485 - 508 .

Yang Y , Wu X , Liu Y , Wang Z , Zhao W , Zhang J , et al . Letter to editor: comparative evaluation of four commercial serological antibody detection kits for the diagnosis of tuberculosis in China . Ann Clin Lab Sci . 2013 ; 43 ( 1 ): 101 - 4 .

Denkinger CM , Schumacher SG , Boehme CC , Dendukuri N , Pai M , Steingart KR . Xpert MTB/RIF assay for the diagnosis of extrapulmonary tuberculosis: a systematic review and meta-analysis . Eur Respir J . 2014 ; 44 ( 2 ): 435 - 46 .

Kanaujia GV , Lam PK , Perry S , Brusasca PN , Catanzaro A , Gennaro ML . Integration of microscopy and serodiagnostic tests to screen for active tuberculosis . Int J Tuberc Lung Dis . 2006 ; 9 ( 10 ): 1120 - 6 .

Dai Y , Feng Y , Xu R , Xu W , Lu W , Wang J . Evaluation of interferon-gamma release assays for the diagnosis of tuberculosis: an updated meta-analysis . Eur J Clin Microbiol Infect Dis . 2012 ; 31 ( 11 ): 3127 - 37 .

Wu X , Li Q , Liang Y , Yang Y , Zhang J , Liang J , et al . Clinical evaluation of a homemade enzyme-linked immunospot assay for the diagnosis of active tuberculosis in China . Mol Biotechnol . 2011 ; 47 ( 1 ): 18 - 25 .

Wu XQ , LiangY WL , Wang ZY , Zhang CY , Yang YR , et al . Latent tuberculosis infection among new recruits to the army in Beijing, China in 2009 . APMIS . 2011 ; 119 ( 6 ): 377 - 84 .

Kunnathvelayudhan S , Salamon H , Wang HY , Davidow AL , Molina DM , Huynh VT , et al . Dynamic antibody responses to the Mycobacterium tuberculosis proteome . Proc Natl Acad Sci U S A . 2010 ; 107 ( 33 ): 14703 - 8 .

Bai XJ , Liang Y , Yang YR , Feng JD , Luo ZP , Zhang JX , et al . Potential novel markers to discriminate between active and latent tuberculosis infection in Chinese individuals . Comp Immunol Microbiol Infect Dis . 2016 ; 44 : 8 - 13 .

Zhang C , Song X , Zhao Y , Zhang H , Zhao S , Mao F , et al . Mycobacterium tuberculosis secreted proteins as potential biomarkers for the diagnosis of active tuberculosis and latent tuberculosis infection . J Clin Lab Anal . 2015 ; 29 ( 5 ): 375 - 82 .

World Health Organization on behalf of the Special Program for Research and Training in Tropical Diseases . Laboratory-based evaluation of 19 commercially available rapid diagnostic tests for tuberculosis . In: Geneva ; 2008 .

Steingart KR , Flores LL , Dendukuri N , Schiller I , Laal S , Ramsay A , et al . Commercial serological tests for the diagnosis of active pulmonary and extrapulmonary tuberculosis: an updated systematic review and metaanalysis . PLoS Med . 2011 ; 8 ( 8 ): e1001062 .

WHO . Policy statement: Commercial serodiagnostic tests for diagnosis of tuberculosis: expert group meeting report . Geneva, Switzerland . Available: http://www.who.int/tb/publications/tb-serodiagnostic-report/en/ http://www.who.int/tb/publications/tb-serodiagnostic-report/en/ . Accessed 12 July 2011 .

Ministry of Health of the People's Republic of China . Diagnosis standard of pulmonary tuberculosis WS288-2008 . Beijing : People's health publishing house . 2008 (in Chinese) .

Basic Specialized Committee of Chinese Anti-Tuberculosis Association . Chinese laboratory science procedure of diagnostic bacteriology in tuberculosis . Beijing : China education and culture press . 2006 (in Chinese) .

Feng X , Yang X , Xiu B , Shuang Q , Dai Z , Chen K , et al . IgG, IgM and IgA antibodies against the novel polyprotein in active tuberculosis . BMC Infect Dis . 2014 ; 14 ( 1 ): 1 - 9 .

Junqueira LCU , Carneiro J . Basic histology: text & atlas : Lange Medical Books/McGraw-Hill ; 2005 .

Welch RJ , Lawless KM , Litwin CM . Antituberculosis IgG antibodies as a marker of active Mycobacterium tuberculosis disease . Clin Vaccine Immunol . 2012 ; 19 ( 4 ): 522 - 6 .

Wu XQ , Ma YZ , Li DW , Yang Y , Liang Y , Xue H , et al . Diagnostic value of ELISPOT technique for osteoarticular tuberculosis . Clin Lab . 2014 ; 60 ( 11 ): 1865 - 70 .

Nonyane BAS , Nicol MP , Andreas NJ , Rimmele S , Schneiderhan-Marra N , Workman LJ , et al . Serologic responses in childhood pulmonary tuberculosis . Pediatr Infect Dis J . 2018 ; 37 ( 1 ): 1 - 9 .

Won-Hyun H , Won-Kyu L , Sung Weon R , Ki-Yeol Y , Gun-Sik T . Expression, Purification and improved antigenicity of the Mycobacterium tuberculosis PstS1 antigen for serodiagnosis . Protein Expr Purif . 2014 ; 95 ( 3 ): 77 - 83 .

Samanich KM , Keen MA , Vissa VD , Harder JD , Spencer JS , Belisle JT , et al . Serodiagnostic potential of culture filtrate antigens of mycobacterium tuberculosis . Clin Diagn Lab Immunol . 2000 ; 7 ( 4 ): 662 - 8 .

Bellinzoni M , Riccardi G . Techniques and applications: the heterologous expression of Mycobacterium tuberculosis genes is an uphill road . Trends Microbiol . 2003 ; 11 ( 8 ): 351 - 8 .

Wu XQ , Yang YR , Zhang JX , Li BY , Liang Y , Zhang CY , et al . Comparison of antibody responses to seventeen antigens from mycobacterium tuberculosis . Clin Chim Acta . 2010 ; 411 ( 19–20 ): 1520 - 8 .

Samanich K , Belisle JT , Laal S . Homogeneity of antibody responses in tuberculosis patients . Infect Immun . 2001 ; 69 ( 7 ): 4600 - 9 .

Burbelo PD , Keller J , Wagner J , Klimavicz JS , Bayat A , Rhodes CS , et al . Serological diagnosis of pulmonary Mycobacterium tuberculosis infection by LIPS using a multiple antigen mixture . BMC Microbiol . 2015 ; 15 ( 1 ): 205 .

Goyal B , Kumar K , Gupta D , Agarwal R , Latawa R , Sheikh JA , et al . Utility of B-cell epitopes based peptides of RD1 and RD2 antigens for immunodiagnosis of pulmonary tuberculosis . Diagn Microbiol Infect Dis . 2014 ; 78 ( 4 ): 391 - 7 .

Russell DG . Who puts the tubercle in tuberculosis? Nat Rev Microbiol . 2007 ; 5 ( 1 ): 39 - 47 .

Khan IH , Ravindran R , Krishnan VV , Awan IN , Rizvi SK , Saqib MA , et al . Plasma antibody profiles as diagnostic biomarkers for tuberculosis . Clin Vaccine Immunol . 2011 ; 18 ( 12 ): 2148 - 53 .

Khalid R , Afzal M , Khurshid S , Paracha RZ , Khan IH , Akhtar MW . Fusion molecules of heat shock protein HSPX with other antigens of Mycobacterium tuberculosis show high potential in Serodiagnosis of tuberculosis . PLoS One . 2017 ; 11 ( 9 ): e0163349 .

Yang Y , Feng J , Zhang J , Zhao W , Liu Y , Liang Y , et al . Immune responses to a recombinant Rv0057-Rv1352 fusion protein of mycobacterium tuberculosis . Ann Clin Lab Sci . 2015 ; 45 ( 1 ): 39 - 48 .

Afzal M , Khurshid S , Khalid R , Paracha RZ , Khan IH , Akhtar MW . Fusion of selected regions of mycobacterial antigens for enhancing sensitivity in serodiagnosis of tuberculosis . J Microbiol Methods . 2015 ; 115 : 104 - 11 .

Sutherland JS , Lalor MK , Black GF , Ambrose LR , Loxton AG , Chegou NN , et al . Analysis of host responses to Mycobacterium tuberculosis antigens in a multi-site study of subjects with different TB and HIV infection states in sub-Saharan Africa . PLoS One . 2013 ; 8 ( 9 ): e74080 .

Demissie A , Leyten E , Abebe M , Wassie L , Aseffa A , Abate G , et al . Recognition of stage-specific mycobacterial antigens differentiates between acute and latent infections with Mycobacterium tuberculosis . Clin Vaccine Immunol . 2006 ; 13 ( 2 ): 179 - 86 .

Pheiffer C , Betts J , Lukey P , Van HP . Protein expression in Mycobacterium tuberculosis differs with growth stage and strain type . Clin Chem Lab Med . 2002 ; 40 ( 9 ): 869 - 75 .

Garton NJ , Waddell SJ , Sherratt AL , Lee SM , Smith RJ , Senner C , et al . Cytological and transcript analyses reveal fat and lazy persister-like bacilli in tuberculous sputum . PLoS Med . 2008 ; 5 ( 4 ): e75 .

Gupta S , Shende N , Bhatia AS , Kumar S , Harinath BC . IgG subclass antibody response to mycobacterial serine protease at different stages of pulmonary tuberculosis . Med Sci Monit . 2005 ; 11 ( 12 ): CR585 - 8 .

Doherty TM , Andersen P . Evaluation of mycobacterium tuberculosis-specific antibody responses in populations with different levels of exposure from Tanzania, Ethiopia, Brazil, and Denmark . Clin Infect Dis . 2007 ; 45 ( 5 ): 575 - 82 .

Wu XQ , Yang YR , Zhang JX , Li BY , Yan L , Zhang CY , et al . Humoral immune responses against the Mycobacterium tuberculosis 38-kilodalton, MTB48, and CFP-10/ESAT-6 antigens in tuberculosis . Clin Vaccine Immunol . 2010 ; 17 ( 3 ): 372 - 5 .

Bai XJ , Liang Y , Yang YR , Li N , Zhang XY , An HR , et al . Immune responses to latent tuberculosis antigen Rv2659c in Chinese populations . J Microbiol Immunol Infect . 2014 ; 48 ( 4 ): 381 - 9 .

Maglione PJ , Xu J , Chan J . B cells moderate inflammatory progression and enhance bacterial containment upon pulmonary challenge with mycobacterium tuberculosis . J Immunol . 2007 ; 178 ( 11 ): 7222 - 34 .

Brust B , Lecoufle M , Tuaillon E , Dedieu L , Canaan S , Valverde V , et al . Mycobacterium tuberculosis Lipolytic enzymes as potential biomarkers for the diagnosis of active tuberculosis . PLoS One . 2011 ; 6 ( 9 ): e25078 .

Fujita Y , Doi T , Sato K , Yano I . Diverse humoral immune responses and changes in IgG antibody levels against mycobacterial lipid antigens in active tuberculosis . Microbiology . 2005 ; 151 ( 6 ): 2065 - 74 .

Li X , Xu H , Jiang S , Jing K , Wang L , Liu X , et al . TB-SA antibody test for diagnosis and monitoring treatment outcome of sputum smear negative pulmonary tuberculosis patients . Southeast Asian J Trop Med Public Health . 2011 ; 42 ( 5 ): 1147 - 53 .

Azzurri A , Kanaujia GV , Sow OY , Bah B , Diallo A , Del PG , et al . Serological markers of pulmonary tuberculosis and of response to anti-tuberculosis treatment in a patient population in Guinea . Int J Immunopathol Pharmacol . 2006 ; 19 ( 1 ): 199 - 208 .

Sireci G , Dieli F , Di LD , Buccheri S , La Manna MP , Scarpa F , et al . Anti-16-kilodalton mycobacterial protein immunoglobulin M levels in healthy but purified protein derivative-reactive children decrease after chemoprophylaxis . Clin Vaccine Immunol . 2007 ; 14 ( 9 ): 1231 - 4 .

Baumann R , Kaempfer S , Chegou NN , Nene NF , Veenstra H , Spallek R , et al . Serodiagnostic markers for the prediction of the outcome of intensive phase tuberculosis therapy . Tuberculosis . 2013 ; 93 ( 2 ): 239 - 45 .

Mani V , Paleja B , Larbi K , Kumar P , Tay JA , Siew JY , et al . Microchip-based ultrafast serodiagnostic assay for tuberculosis . Sci Rep . 2016 ; 6 : 35845 .

Singh N , Sreenivas V , Sheoran A , Sharma S , Gupta KB , Khuller GK , et al . Serodiagnostic potential of immuno-PCR using a cocktail of mycobacterial antigen 85B, ESAT-6 and cord factor in tuberculosis patients . J Microbiol Methods . 2016 ; 120 : 56 - 64 .

Lombardi G , Gregori VD , Girometti N , Tadolini M , Bisognin F , Monte PD . Diagnosis of smear-negative tuberculosis is greatly improved by Xpert MTB/RIF . PLoS One . 2017 ; 12 ( 4 ): e0176186 .

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