Rapid identification of the Mycobacterium tuberculosis complex by an enzyme-linked immunosorbent assay
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.
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: 01 August 2009
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