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Home / The International Journal of Tuberculosis and Lung Disease, Volume 26, Number 9

Evaluation of the MolecuTech® REBA MTB-XMDR kit for detection of pre-extensively drug-resistant TB

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BACKGROUND: Rapid diagnosis of drug-resistant TB is critical for early initiation of effective therapy. YD Diagnostics in South Korea recently developed the MolecuTech® REBA MTB-XMDR test to rapidly detect multidrug-resistant TB (MDR-TB), pre-extensively drug-resistant TB (pre-XDR-TB) and resistance to second-line injectable drugs (SLIDs) simultaneously using a fully automated test platform. This study aimed to evaluate the MolecuTech® test for the detection of MDR- and pre-XDR-TB, as well as SLID resistance.

METHODS: A total of 151 clinical Mycobacterium tuberculosis isolates from South Korea were tested using the MolecuTech test, and the results were analysed by comparing these with phenotypic drug susceptibility testing (pDST) and sequencing.

RESULTS: Compared to pDST, the MolecuTech test showed a sensitivity and specificity of respectively 97.7% and 100.0% for rifampicin (RIF), 82.4% and 100.0% for isoniazid (INH), 97.5% and 97.2% for fluoroquinolones (FQs), and 94.0% and 98.8% for SLIDs. Concordances with the sequencing results of each resistance determinant were 99.3% for RIF, 96.7% for INH, 98.7% for FQs and 99.3% for SLIDs.

CONCLUSION: The MolecuTech test is an efficient and reliable rapid molecular diagnostic tool for the simultaneous screening of MDR- and pre-XDR-TB.

Keywords: drug-resistant tuberculosis; pre-XDR-TB; rapid diagnosis

Document Type: Research Article

Affiliations: 1: International Tuberculosis Research Center, Gyeongsangnam-do, College of Health Sciences, Catholic University of Pusan, Busan, Republic of Korea 2: YD Diagnostics, Gyeonggi-do, College of Health Sciences, Catholic University of Pusan, Busan, Republic of Korea 3: YD Diagnostics, Gyeonggi-do, College of Health Sciences, Catholic University of Pusan, Busan, Republic of Korea, Department of Clinical Laboratory Science, College of Health Sciences, Catholic University of Pusan, Busan, Republic of Korea 4: YD Diagnostics, Gyeonggi-do, College of Health Sciences, Catholic University of Pusan, Busan, Republic of Korea, College of Pharmacy, Dongguk University, Seoul, Republic of Korea 5: Advanced Molecular Research Centre, Department of Medical Research, Yangon, Myanmar

Publication date: September 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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