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
- Diagnostic performance and problem analysis of commercial tuberculosis antibody detection kits in China
- MMR 2018年5卷第3期页码：242-250
- 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：
  
  the Key Project of Army "Twelfth Five-year Plan" Scientific Research Foundation(BWS11J050)
- DOI：10.1186/s40779-018-0157-6
  中图分类号：
- 纸质出版：2018-09
- Accepted：
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Diagnostic performance and problem analysis of commercial tuberculosis antibody detection kits in China[J]. MMR, 2018,5(3):242-250.

Bai et al.: Diagnostic performance and problem analysis of commercial tuberculosis antibody detection kits in China. Mil Med Res, 2018, 5: 10
Diagnostic performance and problem analysis of commercial tuberculosis antibody detection kits in China[J]. MMR, 2018,5(3):242-250. DOI： 10.1186/s40779-018-0157-6.

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

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