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Registration Number

0223U000520, 0122U000580 , R & D reports

Title

Develop an algorithm for the use of new molecular genetic methods in the diagnostic of tuberculosis

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Head

Zhurylo Oleksandr A., Доктор медичних наук

Registration Date

10-01-2023

Organization

State organization "National Institute of Phthisiology and Pulmonology named after F.G. Yanovsky National academy of medical sciences of Ukraine"

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 The object of study − M. tuberculosis strains (MBT) from patients. The aim is to increase is to improve the efficiency of molecular genetics methods of tuberculosis (TB) diagnosis by developing TB diagnosis algorithms and determining the drug resistance (DR) of MBT to antimycobacterial drugs (AMBD). Methods – genetic, bacteriological, statistical, equipment – molecular genetic systems and phenotypic system BACTEC. A scheme of MG diagnosis of pulmonary lesions caused by MBT has been developed, which includes an optimal diagnostic complex of geno-phenotypic diagnosis verification with accelerated determination of the causative DR. It is recommended to use the GeneXpert and GenoType systems for the purpose of identification and determination of DR MBT to AMBD of the 1-st and 2-nd line, it is necessary to conduct research by classical cultural methods in parallel and not to use MG methods to monitor the treatment of TB patients. MTB/RIF Ultra cartridges are recommended for use as an initial diagnostic test for patients with TB symptoms. Sequencing of the 81bp region of the RRDR showed that the GeneXpert MTB/RIF system performed the analysis effectively in detecting mutations associated with R resistance, so it is reasonable to use it for the detection of MDR-TB. When sequencing, the Deeplex Myc-TB analytical solution allows you to obtain a large volume of important information from DR MBT markers to AMBD and speed up the analysis process. The molecular genetic method for determining the drug resistance of M. tuberculosis strains to isoniazid, fluoroquinolones and second-line injectable drugs using GeneXpert MTB/XDR cartridges showed high validity of test results in comparison with LPA testing of MS MBT to H and anti-tuberculosis drugs second-line and the drug resistance phenotypic test, namely sensitivity, specificity, predictive value of positive and negative results (almost 100 % coincidence of results). Sphere of application – phthisiology.

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Barbova Anna I
Zhurylo Oleksandr A.
Korzhov Vitaly I
Myronchenko Svitlana V
Trofimova Polina S
Cherednyk Yuriy O

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2023-01-10