Description

Mycobacterium tuberculosis Complex (MTbC) is a genetically related group of Mycobacterium species that causes tuberculosis (TB) in humans. Antibiotic resistant strains are becoming increasingly prevalent and traditional drug susceptibility testing (DST) relying on culture methods require upwards of 4 weeks to complete. Fluoroquinalones including ciprofloxacin, ofloxacin, levofloxacin and sparfloxacin are commonly used second-line antibiotics in the treatment of tuberculosis which act through inhibition of the bacterial gyrase (gyrA) gene product to block bacterial DNA replication and thus cell growth. Fluoroquinalone resistance can arise through point mutations in gyrA which confer reduced susceptibility to this class of drug.

The MTbC Fluoroquinalone Resistance Determination (qPCR) Kit enables determination of the five most common fluoroquinalone resistance conferring mutations in the MtbC gyrA gene, as well as positively detecting the wild-type (susceptible) form. abm’s kit selectively identifies wild type (WT) or mutant (mut) and is done in a grouped 4-reaction format. Results are obtained by pairwise comparison of sample amplification signals in tubes 1 and 2, and tubes 3 and 4; a results calling algorithm provided in the supplied product handbook then allows interpretation of wild type or mutant status for gyrA.

Assay Overview

This assay is intended for use on extracted DNA from samples known to contain MTbC DNA. Extracted sample cDNA is added to each of the 4 preloaded qPCR tubes and thermocycled according to supplied parameters on a real-time PCR machine with optical monitoring of 495/520nM (excitation/ emission) channel. Results are interpreted according to the supplied product handbook.

Application

• Ease of use – includes pre-loaded reagent strips
• Simple interpretation with positive determination of wild-type (sensitive) genotypes
• Less than two hours from sample preparation to results
• Includes External Positive Control material for validation of kit and processes

Disclaimer

1) This product is developed and intended for research use only. abm is not liable for any repercussions arising from the use of its assay kit(s) in the therapeutic application. 2) Individual assay performance is determined and specified based on abm’s standardized testing on a range of relevant control material, as defined for each particular assay. It is the responsibility of end users to validate these tests in their particular laboratory settings and protocols to a level appropriate to the user’s application.