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Information × Registration Number 0226U000535, (0125U000469) , R & D reports Title Develop an algorithm for the use of targeted sequencing in the diagnosis of tuberculosis and the determination of drug sensitivity of M. tuberculosis to antituberculosis drugs popup.stage_title Обґрунтувати застосування молекулярно-генетичного методу таргетного секвенування M. tuberculosis для дослідження клінічного матеріалу хворих на туберкульоз Head Zhurylo Oleksandr A., Registration Date 12-01-2026 Organization State organization "National scientific center of phthisiatry, pulmonology and allergology named after F. G. Yanovskyi National academy of medical sciences of Ukraine" popup.description1 Increasing the effectiveness of the methods of molecular genetic diagnosis of tuberculosis by developing algorithm for the use of targeted sequencing for diagnosing of tuberculosis and determining of M. tuberculosis the drug sensitivity to antituberculosis drugs; determining the drug sensitivity of M. tuberculosis to antituberculosis drugs popup.description2 The object: M. tuberculosis (MBT), which are isolated from tuberculosis patients and MBT museum strains. The aim: to increase the efficiency of molecular-genetic diagnosis of tuberculosis by developing an algorithm for the use of target sequencing in the diagnosis of tuberculosis and determining the drug sensitivity M. tuberculosis to antimycobacterial drugs. Methods: genetic, bacteriological, statistical, equipment – molecular-genetic system of targeted sequencing MBT on the Illumina MiSeq platform and BACTEC phenotypic system. The use of targeted sequencing (tSNP) of MBT strains for the study of sputum of tuberculosis (TB) patients is substantiated. The obtained results demonstrate the effectiveness of the method for the routine diagnosis of samples where the bacterial load is estimated as ARB2+ or ARB3+. It has been proven that samples from patients with positive microscopy, but with ARB1+ (10-99 ARB per 100 p/eye) should be grown in Middlebrook 7H9 liquid medium in the BACTEC system for 7-8 days. Only after that it is possible to carry out a study of drug resistance (DR) of MBT with the help of tSNP. The effectiveness of the use of tSNP using the Deeplex Myc-TB kit was verified and determined. The minimum indicators in comparison of fDST were: 90.0% sensitivity, 91.7% specificity, overall accuracy not lower than 96.9%. The sensitivity and specificity of the method in detecting resistance of MBT to AMBD is high. PPV ≥ 94.4% and NPV ≥ 94.1% demonstrate the accuracy and compliance of the method with the standard of fDST. Standard operating procedures have been developed for conducting cSNP of MBT strains, which allows obtaining the genomic characterization of MBT strains from patients with various resistance variants, including MDR, pre-WDR and WDR, as well as investigating genetic variants associated with MBT resistance to new and repurposed drugs. Sphere of application – phthisiology, microbiology. Product Description popup.authors Svitlana V. Myronchenko Polina S. Trofimova Vitalii I. Korzhov Oleksandr A. Zhurylo Anna I. Barbova popup.nrat_date 2026-01-12 Close