Bacground: DST by conventional methods takes several weeks, while early diagnosis of the disease and the rapid identification of resistant strains are essential for efficient treatment and control of the MDR strains. Rapid molecular testing of detecting MDR-TB is needed.Objective: The aim of this study was to assess performance of molecular line probe assay, Genotype16 MTBDRp/us, for rapid detection of RIF and INH resistance for M.Tuberculosis in Mongolia. The sensitivity and specificity of Genotype® MTBDRp/us to detect RIF and INH resistance-associated mutations in culture specimens and directly in smear-positive clinical specimens was examined and compared with conventional culture and drug susceptibility testing on solid medium.Material and Methods: The subjects of this study were 218 MDR-TB suspects aged 14-75 years from 8 districts in Ulaanbaatar city. The study was conducted from July 2009 to May 2010. The Genotype M. Tuberculosis drug resistance first line (MTBDR plus) assay (Hain Life-science, Nehren, Germany) was tested on directly on 41 sputum specimens and 109 clinical isolates.Results: The high correlation of the results from Genotype® MTBDRp/us and conventional drug susceptibility testing was obtained from this study. The results clearly show high performance of Genotype® MTBDRp/us with almost 100% accuracy for all the important indicators, such as sensitivity, specificity, positive and negative predictive values of detection of RIF and INH resistance. Some minor discrepancies were obtained in comparison with DNA sequencing results.Our study found that among high proportion for detection of RIF resistance, S531L mutation (MUT3 band) occurred the most commonly, with 80.0% of all RIF-resistant strains (83.6% of MDR) having the mutation. Other mutation in the 530-533 regions was common, as detected by the lack of binding to the WT8 probe in the absence of S531L mutation.In this study we observed that mutations in the promoter region of inhA gene played a major role (67.6 % (63.9% of MDR strains and 90% of INH-mono-resistant strains) had a mutation in the inhA.Conclusion: The Genotype® MTBDRp/us assay was demonstrated as a rapid, reliable and highly accurate tool for early detection of MDR-TB through examining smear positive cases enabling early start of appropriate therapeutic and public health measures to control of the spread of drug resistant M.tuberculosis in the population.

Background: Tuberculosis (TB) is a preventable and usually curable disease. Yet in 2022, TB was the world’s second leading cause of death from a single infectious agent, after coronavirus disease (COVID-19)1. Aim: By reviving strains isolated at specific years over a 10-year interval and performing next-generation sequencing, we can analyze their strain genotype, epidemiology, drug resistance, and dynamicsTherefore, this study was conducted to examine the historical trends and dynamics of strain genotype, variants, and drug resistance of tuberculosis preserved in the culture bank. Materials and Methods:: Using a retrospective, laboratory-based research approach, 200 strains were randomly selected from over 1,000 diagnostic isolates preserved in the NTRL culture collection from 2010 and 2020. Whole-genome sequencing (WGS) was performed using GridION from Oxford Nanopore Technologies (ONT, Oxford, UK) to analyze these strains. The FastQ file was submitted to the International Mycobacterial Database. Strain genotypes, subtypes, gene mutations of drug resistance, and resistance profiles were identified using TBprofiler, MTBseq, IQ-Tree (version 1.6.12), and EPI2me software. Results: Of the tuberculosis strains selected for the study, 66.5% were from eight out of nine districts of Ulaanbaatar, while 33.5% were sampled from 16 out of 21 provinces. Out of the strains analyzed, 83.9% (95% CI 78.7–89.1) belonged to lineage 2 or the Beijing genotype, while 16.1% (95% CI 10.9–21.3) were lineage-4 or Euro-American genotype. While the proportion of Beijing lineage strains was slightly higher and the Euro-American lineage strains slightly lower in rural populations compared to urban populations, the difference in strain distribution between urban and rural areas was not statistically significant (p=0.485). Among the Beijing lineage strains, only the modern Beijing sublineage (100%) was identified. In contrast, the Euro-American lineage exhibited various sublineages: 4 (0.5%), 4.5 (1%), 4.1.2.1 (Haarlem, 3%), Latin American-Mediterranean (LAM, 7.5%), mainly T (3.5%), and S type (0.5%). Notably, the proportion of Lineage 2 strains increased from 80% in 2010 to 86% in 2020. The overlap of the confidence intervals for 2010 (72.16%–87.84%) and 2020 (79.20%–92.80%) indicates that there has been no significant change in the distribution of Mycobacterium tuberculosis lineages over time. The study revealed that among the selected Mycobacterium tuberculosis strains, resistance rates to first-line anti-tuberculosis drugs were as follows: isoniazid (39%), rifampicin (21%), ethambutol (19%), and streptomycin (34%). Genotypic analysis indicated that the Beijing lineage was predominantly associated with drug-resistant tuberculosis cases, including multidrug-resistant (MDR), poly-drug-resistant, and mono-drug-resistant TB. Notably, the Beijing lineage accounted for 100% of pre-extensively drug-resistant (pre-XDR) TB cases. Within the Haarlem lineage, 33% were MDR-TB. In the Latin American-Mediterranean (LAM) lineage, 13.3% were MDR-TB, 6.6% were poly-drug-resistant, and 13.3% were mono-drug-resistant. Among the mainly T lineage, 42.8% exhibited mono-drug resistance. These findings suggest that the distribution of M. tuberculosis lineages in the Mongolian population has remained relatively stable over time, with no significant temporal changes. Conclusion The distribution of M. tuberculosis genotypes circulating among the population of Mongolia has remained relatively stable over time, with no significant time-dependent changes. Additionally, no mutations associated with resistance to newly introduced anti-TB drugs were detected.