Drug Testing for the Qualitative Complex of Multidrug-Resistant M. tuberculosis - Vietnam Registration 2401201ĐKLH/BYT-HTTB

GenoType MTBDRsl VER 2.0 is a qualitative in vitro test to determine the complex of Mycobacterium tuberculosis and the fluoroquinolone (FLQ; e.g., ofloxacin and moxifloxacin) and aminoglycosides/peptides ring (AG/CP; injectable antibiotics such as: kanamycin, amikacin, capreomycin, and viomycin) resistance in sputum samples, both positive and negative, and in culture samples. The following species are included in the complex of M. tuberculosis causing tuberculosis (TB): M. tuberculosis, M. africanum, M. bovis subsp. bovis, M. bovis subsp. caprae, M. bovis BCG, M. microti, M. canettii, and M. pinnipedii. The detection of FLQ resistance is activated by the detection of the most important mutations associated with the resistance of the gyrA and gyrB genes (coding for the A and B subunits of DNA gyrase, respectively). To detect AG/CP resistance, the 16S rRNA gene (rrs) is tested, and to detect low-level kanamycin resistance, the promoter region of the eis gene (coding for the acetyltransferase Eis) is tested. The test is intended as a diagnostic support tool and is used in clinical laboratories.