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J Med Microbiol 57 (2008), 605-611; DOI: 10.1099/jmm.0.47484-0
© 2008 Society for General Microbiology
ISSN 1473-5644

Evaluation of the GenoType Mycobacteria Direct assay for the simultaneous detection of the Mycobacterium tuberculosis complex and four atypical mycobacterial species in smear-positive respiratory specimens

A.-Louise Seagar1, Carmel Prendergast2, F. Xavier Emmanuel1, Alan Rayner1, Susan Thomson3 and Ian F. Laurenson1

1 Scottish Mycobacteria Reference Laboratory, Department of Laboratory Medicine, Royal Infirmary of Edinburgh, 51 Little France Crescent, Edinburgh EH16 4SA, UK

2 Microbiology Department, Royal Brompton Hospital, Sydney Street, London SW3 6NP, UK

3 Mast Group Ltd, MAST House, Derby Road, Bootle, Merseyside L20 1EA, UK

Correspondence
A.-Louise Seagar
Louise.Seagar{at}luht.scot.nhs.uk

Received 29 June 2007
Accepted 2 February 2008

A novel, commercially available reverse hybridization assay [GenoType Mycobacteria Direct (GTMD), version 2.0; Hain Lifescience] was evaluated for the direct detection of five clinically relevant mycobacterial species [Mycobacterium tuberculosis complex (MTBC), Mycobacterium avium, Mycobacterium malmoense, Mycobacterium kansasii and Mycobacterium intracellulare] from 54 smear-positive respiratory specimens and the findings were compared with culture results. Three approaches were used for specimen preparation using either whole or ‘split’ sample volumes and N-acetyl-L-cysteine/3 % NaOH or 4 % NaOH as decontamination chemicals. Forty-three out of 52 samples in which RNA amplification was successful gave GTMD results that concurred with the identification of the cultured isolate. All cases of MTBC were detected. Twenty-two samples contained M. tuberculosis complex, seven had M. kansasii, four had M. malmoense, seven contained atypical mycobacteria other than those detectable using the GTMD assay and three specimens contained no viable mycobacteria. The assay is easy to use and can be completed in one working day. Results interpretation is facilitated by the inclusion of an internal amplification control with each sample to allow identification of specimens containing amplification inhibitors. A positive GTMD result will quickly identify patients with MTBC infection or provide specific identification of four other atypical mycobacteria from the same specimen. This allows more rapid drug susceptibility testing, treatment, and public health and infection control decisions.

Abbreviations: AFB, acid-fast bacilli; CDAT, commercial direct amplification test; GTMD, GenoType Mycobacteria Direct; MTBC, Mycobacterium tuberculosis complex; NTM, non-tuberculous mycobacteria; SMRL, Scottish Mycobacteria Reference Laboratory; TB, tuberculosis.






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