Development and Evaluation of a Molecular Assay for Detection of Nontuberculous Mycobacteria by Use of the Cobas Amplicor Platform

We have developed and evaluated a semiautomated assay for detection of nontuberculous mycobacteria (NTM) from clinical samples based on the Cobas Amplicor Mycobacterium tuberculosis test (Roche Diagnostics, Switzerland). A capture probe, specific for mycobacteria at the genus level, was linked to ma...

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Bibliographic Details
Published in:Journal of Clinical Microbiology 2008-12, Vol.46 (12), p.4023-4028
Main Authors: Peter-Getzlaff, S, Lüthy, J, Böddinghaus, B, Böttger, E.C, Springer, B
Format: Article
Language:English
Subjects:
Bacteriology
Biological and medical sciences
Fundamental and applied biological sciences. Psychology
Humans
Magnetics
Microbiology
Microspheres
Miscellaneous
Mycobacteriology and Aerobic Actinomycetes
Mycobacterium - isolation & purification
Mycobacterium Infections - diagnosis
Mycobacterium Infections - microbiology
Mycobacterium tuberculosis
Nucleic Acid Amplification Techniques - methods
Oligonucleotide Probes - genetics
Predictive Value of Tests
Sensitivity and Specificity
Switzerland
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Summary:We have developed and evaluated a semiautomated assay for detection of nontuberculous mycobacteria (NTM) from clinical samples based on the Cobas Amplicor Mycobacterium tuberculosis test (Roche Diagnostics, Switzerland). A capture probe, specific for mycobacteria at the genus level, was linked to magnetic beads and used for the detection of amplification products obtained by the Cobas Amplicor M. tuberculosis assay. We demonstrate that the analytical sensitivity of the genus assay is similar to that of Cobas Amplicor M. tuberculosis detection. Four hundred sixteen clinical specimens were evaluated for the presence of NTM DNA. Sensitivities for smear-positive and smear-negative specimens were found to be 100% and 47.9%, respectively. Specificity was 97.7%, the positive predictive value 84.6%, and the negative predictive value 93.1%. The genus assay is easy to perform, produces reliable results, and was found to be a valuable diagnostic tool for rapid diagnosis of infections with NTM. The genus assay has the potential to detect NTM not routinely recovered by culture and to discover new mycobacterial species.
ISSN:0095-1137
1098-660X
DOI:10.1128/JCM.01101-08