The effectiveness of Hain MTBDR in determining the resistance of M. Tuberculosis to anti-tuberculosis drugs

Rezumat

According to the WHO, about 10 million people fall ill with tuberculosis every year, 1.2-1.4 million of them die. Drug-resistant forms of tuberculosis make a significant contribution to this statistic - 483,000-639,000 new cases of multidrugresistant (MDR-TB) and extensively drug resistant (XDR-TB) tuberculosis are recorded annually. This study was performed to evaluate the sensitivity and specificity of molecular-genetic diagnostic method Hain MTBDR in comparison to cultural methods of determining M. tuberculosis drug resistance. Materials and methods. 3527 sputum specimens from TB patients were investigated by Hain MTBDR and cultural methods (BACTEC and solid Lowenstein-Jensen medium) during 2018-2019. Results. 25 inconsistencies were found between the results of Hain MTBDR and cultural methods, which accounted for 0.7% of all tests performed. The sensitivity of Hain MTBDR in this study was 99.7%, and specificity - 99.6%. Most of the inconsistencies in the results of molecular genetic and cultural research methods (12 cases) accounted for the determination of resistance to fluoroquinolones. Of these, mutations in the gyrA gene were found in 10 cases, corresponding to resistance to fluoroquinolones, which were not confirmed subsequently. Conclusions. Hain MTBDR is a fast, highly sensitive, highly specific and relatively economical method for diagnosing drug resistance of M. tuberculosis.