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Free Content Rapid identification of the Mycobacterium tuberculosis complex by an enzyme-linked immunosorbent assay

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SETTING: A medical centre in Taipei, Taiwan.

OBJECTIVE: To investigate the performance of an enzyme-linked immunosorbent assay (ELISA) using anti-early secreted antigenic target 6 and culture filtrate protein 10 antibodies (MeDiPro Mycobacterium tuberculosis Antigen ELISA) for the detection of M. tuberculosis in positive signals of Mycobacterium Growth Indicator Tubes (MGIT; BACTEC MGIT 960 system).

DESIGN: A total of 208 consecutive clinical samples, including 185 respiratory specimens and 23 non-respiratory specimens, with positive signals in MGIT were analysed. The assay was performed on Days 1 and 7. The ELISA and conventional culture results were compared.

RESULTS: Among the tubes with positive signals, 86 (41.3%) were M. tuberculosis, 55 (26.4%) were non-tuberculous mycobacteria and 67 (32.2%) were negative for mycobacteria. The sensitivity of the ELISA for tubes with positive signals (initial smear with positive acid-fast bacilli) on Days 1 and 7 was respectively 75.6% (70.5%) and 96.5% (97.7%), and the specificity was respectively 98.4% (100%) and 100% (100%).

CONCLUSION: Our results show that the MeDiPro M.tuberculosis Antigen ELISA is a simple, rapid assay (<3 h) for M. tuberculosis antigen detection, especially on Day 7 of incubation with positive signals in the BACTEC MGIT 960 system.
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Keywords: CFP-10; ESAT-6; Mycobacterium tuberculosis; Taiwan; enzyme-linked immunosorbent assay

Document Type: Regular Paper

Affiliations: 1: Department of Internal Medicine, Yun-Lin Branch, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan 2: Department of Laboratory Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan; and Department of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan 3: Department of Laboratory Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan 4: Department of Internal Medicine, Yi-Min Hospital, Taipei, Taiwan 5: Department of Internal Medicine, Far Eastern Memorial Hospital, Taipei County, Taiwan

Publication date: 2009-08-01

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  • The International Journal of Tuberculosis and Lung Disease publishes articles on all aspects of lung health, including public health-related issues such as training programmes, cost-benefit analysis, legislation, epidemiology, intervention studies and health systems research. The IJTLD is dedicated to the continuing education of physicians and health personnel and the dissemination of information on tuberculosis and lung health world-wide.

    Certain IJTLD articles are selected for translation into French, Spanish, Chinese or Russian. They are available on the Union website

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