EFFICACY OF LOOP MEDIATED ISOTHERMAL AMPLIFICATION (LAMP) ASSAY IN DETECTING MYCOBACTERIUM TUBERCULOSIS IN EXTRAPULMONARY SAMPLES.

Introduction: Despite the availability of highly efficacious treatments for decades, tuberculosis remains a major public health issue worldwide. In 2017, WHO reported that 10.0 million people developed TB, mainly in developing countries, and that approximately 3.6 million (36%) were not diagnosed or notified to the national authorities. The most widely used method for TB diagnosis is sputum smear microscopy. This test is simple, rapid, and inexpensive but has a relatively low sensitivity, particularly in patients with extrapulmonary TB, children, and in people with HIV. Hence, the development of new diagnostic tools suitable for use in low- and middle-income countries is one of the top priorities for TB control. Materials and Methods: A Prospective study conducted from January 2023- December 2023 (12 months) in the Department of Respiratory Medicine, Gayatri Vidya Parishad Institute of Health Care and Medical Technology, Visakhapatnam). Sputum samples collected from all patients suspected to have pulmonary tuberculosis due to Mycobacterium tuberculosis complex. Samples were collected from those patients who fulfilled the following clinical criteria. Data were analysed using SPSS to determine specificity and sensitivity of LAMP in comparison to culture for detection of Mycobacterium Tuberculosis. The sputum specimens that full filled the criteria were included in this study. Around 50 sputum samples were collected and processed. Results: Hundred sputum samples which were fitted into the criteria were processed. 50 sputum samples male patients 65%, and the remaining 35% were obtained from female patient. It shows majority of presumptive pulmonary tuberculosis patients were males. Among the 50 sputum samples that were received in the laboratory, maximum number of 15 patients fall under the age group 51-60 years, followed by 13 patients in 61-70 years and 9 patients between 41-50 years. Least incidence was seen under the extreme age groups less than 10 years, and greater than 81 years. Conclusion: The sensitivity and specificity of LAMP and Gene Xpert MTB/RIF were almost equal in our study. In comparison to LAMP, Gene Xpert MTB/RIF machine and its consumables (cartridge) are very expensive. Moreover Gene Xpert MTB/RIF requires air conditioning; fluctuation in temperature adversely affects its performance, so it is not feasible to implement in peripheral health centres. LAMP is cost effective (50% lesser cost than Xpert), less time consuming (1.5 hour, faster than Xpert), requires minimal amount of sputum and is not adversely affected by temperature fluctuation, making it ideal for use in peripheral poor resource health centres. [ABSTRACT FROM AUTHOR]