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Home / The International Journal of Tuberculosis and Lung Disease, Volume 15, Number 9

Evaluation of a simple loop-mediated isothermal amplification test kit for the diagnosis of tuberculosis

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OBJECTIVE: A new loop-mediated isothermal amplification (LAMP) test kit, including a simple DNA extraction device for the detection of Mycobacterium tuberculosis complex, was developed for commercial use and evaluated for its usefulness in diagnosing tuberculosis (TB).

DESIGN: The LAMP test was performed using untreated and N-acetyl-L-cysteine (NALC) NaOH-treated sputum specimen. The efficiency of the kit was compared with other conventional laboratory examinations, including other nucleic acid amplification (NAA) tests.

RESULTS: The sensitivity of LAMP using raw sputum (direct LAMP) in smear- and culture-positive specimens was 98.2% (95%CI 94.9–99.4), while the sensitivity in smear-negative, culture-positive specimens was 55.6% (95%CI 43.4–68.0). The diagnostic sensitivity of direct LAMP for the diagnosis of individuals with TB was 88.2% (95%CI 81.4–92.7). The sensitivity values of direct LAMP were slightly, but not statistically significantly lower than those of Cobas Amplicor MTB and TRC Rapid MTB, while the sensitivity of the LAMP test using NALC-NaOH treated sputum was significantly lower than other NAA tests (P < 0.05) for smear-negative, culture-positive specimens. The new commercial version of the LAMP kit was easy to handle and yielded results within 1 h of receiving sputum specimens.

CONCLUSIONS: This test is considered a promising diagnostic tool for TB, even for peripheral laboratories with limited equipment, such as those in developing countries.

Keywords: LAMP; diagnosis; tuberculosis

Document Type: Regular Paper

Affiliations: 1: Department of Mycobacterium Reference and Research, Bacteriology Division, Research Institute of Tuberculosis, Japan Anti-Tuberculosis Association, Tokyo, Japan 2: Department of Respiratory and Internal Medicine, Double-Barred Cross Hospital, Japan Anti-Tuberculosis Association, Tokyo, Japan 3: Department of Respiratory and Internal Medicine, National Hospital Organisation, Tokyo Hospital, Tokyo, Japan 4: Microbiology Laboratory, Double-Barred Cross Hospital, Japan Anti-Tuberculosis Association, Tokyo, Japan 5: Microbiology Laboratory, National Hospital Organisation, Tokyo Hospital, Tokyo, Japan

Publication date: 01 September 2011

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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.

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