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Home / The International Journal of Tuberculosis and Lung Disease, Volume 20, Number 6

Capilia™ TB-Neo assay: a new tool for rapid distinction between tuberculous and non-tuberculous mycobacteria

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SETTING: The ability to rapidly distinguish between Mycobacterium tuberculosis complex (MTC) and non-tuberculous mycobacteria (NTM) is critical in clinical practice.

OBJECTIVE: To evaluate the usefulness of an immunochromatographic (IC) assay to distinguish between MTC and NTM.

DESIGN: We analysed a panel of 145 cultures from 128 patients. The routine molecular identification approaches, such as the AccuProbe™ Mycobacterium tuberculosis complex culture identification test and GenoType® Mycobacterium assays, were used as reference methods.

RESULTS: Of the 101 positive cultures, 98 were correctly identified using the Capilia™ TB-Neo Assay. Of the three discordant isolates, one was identified as M. bovis bacille Calmette-Guérin (BCG) and two as M. tuberculosis. Although we have not performed the sequencing of these strains, some false-negative results have been described due to mutations in the mpb64 gene or with some M. bovis BCG strains. We did not observe false-positive results or any cross-reaction with 22 NTM strains, 12 non-mycobacterial micro-organisms and 10 negative cultures.

CONCLUSION: We report good overall performance (sensitivity 97%, specificity 100%, positive predictive value 100% and negative predictive value 96%) of this rapid assay that is easy to perform and interpret and does not require sample preparation, trained technicians or expensive equipment.

Keywords: diagnosis; immunochromatographic assay; mycobacteriology; tuberculosis

Document Type: Research Article

Affiliations: 1: Clinical Pathology Department, São João Hospital Centre, Porto, EPI Unit, Institute of Public Health, University of Porto, Porto 2: Clinical Pathology Department, São João Hospital Centre, Porto 3: Clinical Pathology Department, São João Hospital Centre, Porto, EPI Unit, Institute of Public Health, University of Porto, Porto, Faculty of Medicine, University of Porto, Porto, Portugal

Publication date: 01 June 2016

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  • The International Journal of Tuberculosis and Lung Disease (IJTLD) is for clinical research and epidemiological studies on lung health, including articles on TB, TB-HIV and respiratory diseases such as COVID-19, asthma, COPD, child lung health and the hazards of tobacco and air pollution. Individuals and institutes can subscribe to the IJTLD online or in print – simply email us at [email protected] for details.

    The IJTLD is dedicated to understanding lung disease and to the dissemination of knowledge leading to better lung health. To allow us to share scientific research as rapidly as possible, the IJTLD is fast-tracking the publication of certain articles as preprints prior to their publication. Read fast-track articles.

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