The Role of TB-LAMP Method in Detecting Mycobacterium tuberculosis from Sputum of Patients Suspected of Having Pulmonary Tuberculosis
Background: Indonesia is one of the countries with the highest incidence of tuberculosis (TB) in the world. Appropriate diagnosis is an effort to control TB. The World Health Organization has recommended loop-mediated isothermal amplification (LAMP). In order to be applied routinely, it is necessary to do research to evaluate the LAMP method. Methods: the research was a cross-sectional study and was carried out at the Clinical Microbiology Laboratory of the Faculty of Medicine, Universitas Indonesia, for 100 patients suspected of having pulmonary TB. Each patient handed over two direct sputum specimens. For each direct sputum specimen, an acid-fast bacilli (AFB) smear was carried out. Two direct sputum specimens from each patient were combined to produce mixed sputum. For each mixed sputum specimen, an AFB smear, Lowenstein-Jensen culture, and TB-LAMP were carried out. Results: the percentage of LAMP (+) cells in mixed sputum that was AFB (-) was 32.78%. The TB-LAMP showed a sensitivity of 100% (95% CI 89.56–100%), a specificity of 69.64% (95% CI 55.74–80.84%), positive predictive value of 71.19% (95% CI 57.73–81.86%), and negative predictive value of 100% (95% CI 88.83–100%). Conclusion: TB-LAMP has both high sensitivity and negative predictive value.
World Health Organization. Global Tuberculosis Report. Geneva: World Health Organization; 2016. p. 201.
Ministry of Health The Republic of Indonesia (Kementerian Kesehatan Republik Indonesia). Indonesian Health Profiles (Profil Kesehatan Indonesia). Jakarta; 2015. p. 22. Indonesian.
Directorate General for Disease Control and Enviromental Health Ministry of Health The Republic of Indonesia (Direktorat Jenderal Pengendalian Penyakit dan Penyehatan Lingkungan Kementerian Kesehatan Republik Indonesia). National Guideline for Tuberculosis Control (Pedoman Nasional Pengendalian Tuberkulosis). Jakarta; 2014. p. 150. Indonesian.
World Health Organization. Implementing tuberculosis diagnostics: policy framework. Geneva: World Health Organization; 2015. p. 39.
Datta S, Shah L, Gilman RH, Evans CA. Comparison of sputum collection methods for tuberculosis diagnosis: a systematic review and pairwise and network meta-analysis. Lancet Glob Health. 2017;5(8):e760–e771.
World Health Organization. The use of loop-mediated isothermal amplification (TB-LAMP) for the diagnosis of pulmonary tuberculosis: Policy guidance. Geneva: World Health Organization; 2016. p. 38.
Eiken Chemical Co. Ltd. Eiken Genome Site: Design of primers [Web page]. 2005. Available from: http://loopamp.eiken.co.jp/e/lamp/primer.html. Cited July 4, 2019.
Eiken Chemical Co. Ltd. Loopamp MTBC Detection Kit 380236–A Ref 972000 [Insert]. Japan; 2015.
Gray CM, Katamba A, Narang P, et al. Feasibility and operational performance of tuberculosis detection by loop-mediated isothermal amplification platform in decentralized settings: results from a multicenter study. J Clin Microbiol. 2016;54(8):1984–91.
Directorate General for Medical Service Ministry of Health The Republic of Indonesia (Direktorat Jenderal Bina Upaya Kesehatan Kementerian Kesehatan Republik Indonesia). Technical procedures for Mycobacterium tuberculosis culture, identification and drug susceptibility test in solid media (Petunjuk teknis pemeriksaan biakan, identifikasi, dan uji kepekaan Mycobacterium tuberculosis pada media padat). Jakarta; 2012. p. 114. Indonesian.
World Health Organization. Global Tuberculosis Report. Geneva: World Health Organization; 2018. p. 231.
Kim CK, Cho EA, Shin DM, Choi SW, Shin SY. Comparative evaluation of the loop-mediated isothermal amplification assay for detecting pulmonary tuberculosis. Ann Lab Med. 2018;38(2):119–24.
Mitarai S, Okumura M, Toyota E, et al. Evaluation of a simple loop-mediated isothermal amplification test kit for the diagnosis of tuberculosis. Int J Tuberc Lung Dis. 2011;15(9):1211–7.
Gordillo-Marroquín C, Gómez-Velasco A, Sánchez-Pérez H, et al. Magnetic nanoparticle-based biosensing assay quantitatively enhances acid-fast bacilli count in paucibacillary pulmonary tuberculosis. Biosensors (Basel). 2018;8(4):128.
Jankovic VK, Furci L, Cirillo DM. Microbiology of Mycobacterium tuberculosis and a new diagnostic test for TB. In: Lange C, Migliori GB, editors. European respiratory monograph. Sheffield: European Respiratory Society; 2012. p. 1-13.
Bentaleb EM, Abid M, Messaoudi MDE, et al. Development and evaluation of an in-house single step loop-mediated isothermal amplification (SS-LAMP) assay for the detection of Mycobacterium tuberculosis complex in sputum samples from Moroccan patients. BMC Infect Dis. 2016;16(1):517.
Alom S, Mondal KJ, Tarafder S, et al. Evaluation of loop mediated isothermal amplification (Lamp) assay for diagnosis of Mycobacterium tuberculosis in sputum samples. IOSR-JDMS. 2018;17(6):63–8.
Senarath K, Usgodaarachchi R, Navaratne V, et al. Non specific amplification with the LAMP technique in the diagnosis of tuberculosis in Sri Lankan settings. J Tuberc Res. 2014;2(4):168–72.
Sartorius. Preventing Contamination in Pipetting [Web page]. 2016. Available from: https://www.labmanager.com/laboratory-technology/2016/02/preventing-contamination-in-pipetting#.XR7gH-gzbIU. Cited July 5, 2019.
Wang D, Brewster J, Paul M, Tomasula PM. Two methods for increased specificity and sensitivity in loop-mediated isothermal amplification. Molecules. 2015;20(4):6048–59.
Suleman E, Mtshali M, Lane E. Investigation of false positives associated with loop-mediated isothermal amplification assays for detection of Toxoplasma gondii in archived tissue samples of captive felids. J Vet Diagn Invest. 2016;28(5):536–42.
Wei L, Huang S, Liu N, et al. Establishment of an accurate and fast detection method using molecular beacons in loop-mediated isothermal amplification assay. Sci Rep. 2017;7:40125.
Bi A, Nakajima C, Fukushima Y, et al. A rapid loop-mediated isothermal amplification assay targeting hspX for the detection of Mycobacterium tuberculosis complex. Jpn J Infect Dis. 2012;65(3):247–51.
World Health Organization. World Health Organization model list of essential in vitro diagnostics. 1st ed. Geneva: World Health Organization; 2018. p. 28.
Pham TH, Peter J, Mello FCQ, et al. Performance of the TB-LAMP diagnostic assay in reference laboratories: results from a multicentre study. Int J Infect Dis. 2018;68:44–9.
Nakiyingi L, Nakanwagi P, Briggs J, et al. Performance of loop-mediated isothermal amplification assay in the diagnosis of pulmonary tuberculosis in a high prevalence TB/HIV rural setting in Uganda. BMC Infect Dis. 2018;18(1):87.
Nliwasa M, MacPherson P, Chisala P, et al. The sensitivity and specificity of loop-mediated isothermal amplification (LAMP) sssay for tuberculosis diagnosis in adults with chronic cough in Malawi. PLoS One. 2016;11(5):e0155101.
- There are currently no refbacks.