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Early line-probe assay using DNA specimens in patients with pulmonary TB

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BACKGROUND: We investigated the feasibility of early line-probe assay (LPA) using remnant DNA of Mycobacterium tuberculosis from polymerase chain reaction (PCR) test.

METHODS: M. tuberculosis DNA specimens with cycle threshold (Ct) values reported and collected from patients with known results for both LPA with culture isolates and phenotype drug susceptibility testing (pDST) were selected. The diagnostic performance of DNA-based LPA according to the Ct value was investigated.

RESULTS: A total of 143 respiratory specimens were included. For isoniazid resistance, the accuracy in subgroups with Ct value <25, 25–29 and ≥29 was respectively 96.8%, 65.7% and 13.3%. For rifampicin resistance, accuracy in subgroups with Ct values <29 and ≥29 was respectively 87.8% and 13.3%. When compared to the pDST results, sensitivity, specificity, positive predictive value and negative predictive value in specimens with Ct values <25 was respectively 1.00 (95% CI 0.69–1.00), 0.95 (95% CI 0.76–1.00), 0.91 (95% CI 0.59–1.00) and 1.00 (95% CI 0.83–1.00) for isoniazid resistance. For rifampicin resistance, corresponding values in subgroups with Ct values <29 were respectively 0.89 (95% CI 0.52–1.00), 0.98 (95% CI 0.91–1.00), 0.80 (95% CI 0.50–0.94) and 0.99 (95% CI 0.92–1.00).

CONCLUSIONS: DNA-based early LPA with remnant DNA from respiratory samples was feasible and accurate when the Ct values were low.

Keywords: Genotype; microbial sensitivity tests; multidrug-resistant; sensitivity and specificity; tuberculosis

Document Type: Research Article

Affiliations: 1: Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Incheon St Mary´s Hospital, Republic of Korea 2: Department of Laboratory Medicine, Seoul St Mary´s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea

Publication date: June 1, 2022

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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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