|Registration Date||12 Jun 2017|
Medicine Medical SuppliesReagent kit
Specificity of 80% for fluoroquinolone-resistant Mycobacterium tuberculosis strains. The sensitivity of not less than 500 genome equivalents mycobacteria (100-300 CFU in 1 ml sputum). Analysis time is less than 1 day.
A set of reagents for the detection of Mycobacterium tuberculosis and to determine their drug sensitivity to fluoroquinolones by hybridization with a fluorescent image on a biological microchip (TB-biochip 2)" is intended to determine the causative agent of tuberculosis resistance to fluoroquinolones (registration certificate of the Federal Service on Surveillance in Healthcare and Social number of FSR2010 / 08 555 from 05.08.2010g.).KIT COMPONENTS:
N1 set to isolate the DNA of Mycobacterium tuberculosis from sputum;N2 kit for polymerase chain reaction (PCR);N3 set for electrophoresis;Set N4, including biological microchips to identify the type of point mutation by hybridization.Operating procedure:
Sampling of diagnostic material. Destruction tuberculosis pathogens in sputum cells with DNA release. Conducting a polymerase chain reaction (PCR) for the operating time required for genetic analysis of DNA fragments with simultaneous introduction of fluorescent tags. Hybridization (interaction) of fluorescently-labeled DNA fragments with oligonucleotide probes on a biochip.Automatic analysis of results of hybridization on the biochip using a universal hardware and software, report writing