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Free Content Redefining MTBDRplus test results: what do indeterminate results actually mean?

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BACKGROUND: Although line-probe assays (LPAs) are promising, little research has been conducted to elucidate the true nature of indeterminate LPA results or assess the ability of these assays to perform on a wide range of clinical samples.

OBJECTIVE: To evaluate the performance of the commercially available GenoType® MTBDRplus LPA against conventional BACTEC™ MGIT™ 960 culture and drug susceptibility testing (DST) among 308 pulmonary tuberculosis (PTB) and 32 extra-pulmonary TB samples.

RESULTS: Invalid LPA results (defined as those with a missing Mycobacterium tuberculosis identification band) were obtained for 18 PTB samples, which were excluded from further analysis. The sensitivity and specificity of the MTBDRplus assay for multidrug-resistant TB, based upon the results obtained for the remaining 322 samples, was respectively 95.2% and 95.1%. Of 290 PTB samples, 40 (13.7%) were indeterminate on LPA (defined as the absence of both wild-type and corresponding mutation bands) for isoniazid (INH) and/or rifampicin (RMP), and were further evaluated by pyrosequencing (PSQ). Contrary to standard LPA interpretation, INH and RMP susceptibility were confirmed by both DST and PSQ in respectively 7.5% (3/40) and 27.5% (11/40) of indeterminate samples.

CONCLUSION: PSQ was found to be a valuable and rapid technique to resolve discrepancies in LPA test results that were not interpretable.
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Keywords: drug resistance; heteroresistance; indeterminate; pyrosequencing; tuberculosis

Document Type: Research Article

Affiliations: 1: *Department of Microbiology, P D Hinduja Hospital and Medical Research Centre, Mumbai, India 2: Department of Medicine, University of California San Diego, La Jolla, California, USA

Publication date: 01 February 2016

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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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