No Title 0.03 MB
Registration Date 12 Jun 2017



Medicine Medical Supplies

Reagent kit


Tuberculosis resistance Fluoroquinolone-resistant Mycobacterium tuberculosis strains


Analytical sensitivity set - 500 genome equivalents of DNA Mycobacterium tuberculosis complex (the amount of DNA in a single reaction tube during the PCR step) Diagnostic sensitivity and specificity of the identification of Mycobacterium tuberculosis complex in clinical samples with positive microscopy - not less than 99% Detectable genetic determinants and extensively drug-resistant tuberculosis pathogen, total - 120 determinants, incl .: 28 mutations in rpoB , responsible for rifampicin resistance 11 mutations in the gene katG , 5 mutations in a gene inhA , 5 mutations in a gene ahpC , resulting in resistance to Isoniazid 23 mutations in the gene embB , responsible for the resistance to ethambutol 15 mutations in gyrA , 23 mutations in the gene gyrB , responsible for the resistance to fluoroquinolones 4 mutations in the gene rrs , 6 mutations in the gene eis , leading to resistance to amikacin, kanamycin and capreomycin The establishment of the genotype most endemic (widespread in the Russian Federation) Mycobacterium tuberculosis strains - LAM, Haarlem, Ural, Beijing, Beijing B0 / W148 The analysis time - not more than 1 day

Manufacturer's Description

Reagent kit for the identification of DNA Mycobacterium tuberculosis, establish its genotype with simultaneous determination of the genetic determinants of resistance to rifampicin, isoniazid, fluoroquinolones, injectable drugs (amikacin, and kanamycin), capreomycin, and ethambutol (the registration certificate of the Federal Service on Surveillance in Healthcare and Social Development of number RZN2014 / 1709 from 22.01.2015g.).Appointment set:
Set TB-120 TEST reveals both genetic determinants of sustainability, and determines the belonging to the tuberculosis pathogen endemic in Russian families Beijing, Beijing B0, LAM, Haarlem, Ural. Set TB TEST reagent is a powerful tool for personalized medicine, revealing in one analysis of genetic determinants and extensively drug-resistant tuberculosis pathogen and provide optimal choice of effective drugs for the individual patient.
Principle of operation:
The test procedure involves a one-step multiplex amplification and fluorescent labeling of mycobacterial genomic fragments followed by hybridization with the PCR products on a biochip. Oligonucleotide biochip comprises immobilized probes, the sequences of which are specific to a fragment of the insertion element IS6110, characteristic Mycobacterium tuberculosis complex, single nucleotide polymorphisms that establishes belonging tuberculosis agent to endemic for the RF families Beijing, Haarlem, LAM, Ural, but also mutant variants of gene rpoB , katG , inhA , ahpC , gyrA , gyrB , rrs , eis, embB , is a marker of TB drug resistance. Registration and interpretation of the results of hybridization on the biochip is performed automatically using UAPK