Evaluation of the rapid MGIT TBc identification test for culture confirmation of Mycobacterium tuberculosis complex strain detection

Ming Chih Yu, Huang Yao Chen, Mei Hua Wu, Wei Lun Huang, Yuh Min Kuo, Fang Lan Yu, Ruwen Jou

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Abstract

A culture confirmation test for the detection of Mycobacterium tuberculosis complex strains that uses a lateral-flow immunochromatographic assay to detect the MPB64 antigen, the MGIT TBc identification (TBc ID) test, has been developed. We evaluated the performance of the TBc ID test in the detection of the M. tuberculosis complex in 222 primary-positive liquid cultures. We compared these results to those of nucleic acid-based identification and conventional biochemical tests. The validity of the TBc ID test was determined, and all of the nontuberculous mycobacteria (NTM) and Nocardia species tested were found to be negative. The detection limit of the TBc ID test was 5 × 105 CFU/ml, and for IS6110 real-time PCR it was 5 CFU/ml. All of the M. tuberculosis and M. africanum cultures were found to be positive, while M. bovis and M. bovis BCG cultures were negative. With the exception of 1 contaminated culture, the 221 culture-positive isolates contained 171 (77.5%) M. tuberculosis isolates, 39 (17.6%) NTM species, and 11 (5.0%) unidentified species. Two culture-positive isolates harbored a 63-bp deletion at position 196 of the mpb64 gene. The sensitivity, specificity, positive predictive values, and negative predictive values of the TBc ID test were 98.8, 100, 100, and 95.1%, respectively. Furthermore, the approximate turnaround time for real-time PCR was 4 h (including buffer and sample preparation), while for the TBc ID test it was less than 1 h. We suggest an algorithm for the primary identification of M. tuberculosis in liquid culture using the TBc ID test as an alternative to conventional subculture followed by identification using biochemical methods.

Original languageEnglish
Pages (from-to)802-807
Number of pages6
JournalJournal of Clinical Microbiology
Volume49
Issue number3
DOIs
Publication statusPublished - Mar 2011

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Mycobacterium tuberculosis
Nontuberculous Mycobacteria
Real-Time Polymerase Chain Reaction
Immunochromatography
Nocardia
Mycobacterium bovis
Nucleic Acids
Limit of Detection
Buffers
Antigens
Sensitivity and Specificity
Genes

ASJC Scopus subject areas

  • Microbiology (medical)

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Evaluation of the rapid MGIT TBc identification test for culture confirmation of Mycobacterium tuberculosis complex strain detection. / Yu, Ming Chih; Chen, Huang Yao; Wu, Mei Hua; Huang, Wei Lun; Kuo, Yuh Min; Yu, Fang Lan; Jou, Ruwen.

In: Journal of Clinical Microbiology, Vol. 49, No. 3, 03.2011, p. 802-807.

Research output: Contribution to journalArticle

Yu, Ming Chih ; Chen, Huang Yao ; Wu, Mei Hua ; Huang, Wei Lun ; Kuo, Yuh Min ; Yu, Fang Lan ; Jou, Ruwen. / Evaluation of the rapid MGIT TBc identification test for culture confirmation of Mycobacterium tuberculosis complex strain detection. In: Journal of Clinical Microbiology. 2011 ; Vol. 49, No. 3. pp. 802-807.
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abstract = "A culture confirmation test for the detection of Mycobacterium tuberculosis complex strains that uses a lateral-flow immunochromatographic assay to detect the MPB64 antigen, the MGIT TBc identification (TBc ID) test, has been developed. We evaluated the performance of the TBc ID test in the detection of the M. tuberculosis complex in 222 primary-positive liquid cultures. We compared these results to those of nucleic acid-based identification and conventional biochemical tests. The validity of the TBc ID test was determined, and all of the nontuberculous mycobacteria (NTM) and Nocardia species tested were found to be negative. The detection limit of the TBc ID test was 5 × 105 CFU/ml, and for IS6110 real-time PCR it was 5 CFU/ml. All of the M. tuberculosis and M. africanum cultures were found to be positive, while M. bovis and M. bovis BCG cultures were negative. With the exception of 1 contaminated culture, the 221 culture-positive isolates contained 171 (77.5{\%}) M. tuberculosis isolates, 39 (17.6{\%}) NTM species, and 11 (5.0{\%}) unidentified species. Two culture-positive isolates harbored a 63-bp deletion at position 196 of the mpb64 gene. The sensitivity, specificity, positive predictive values, and negative predictive values of the TBc ID test were 98.8, 100, 100, and 95.1{\%}, respectively. Furthermore, the approximate turnaround time for real-time PCR was 4 h (including buffer and sample preparation), while for the TBc ID test it was less than 1 h. We suggest an algorithm for the primary identification of M. tuberculosis in liquid culture using the TBc ID test as an alternative to conventional subculture followed by identification using biochemical methods.",
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