Rifampicin & Isoniazid Drug Resistant MTB Detection Kit

NEED

Worldwide, TB is one of the top 10 causes of death and the leading cause from a single infectious agent. It is one of the main causes of morbidity and mortality, due to the emergence of antibiotic resistant Mycobacterium strains. In 2016, an estimated 490,000 people worldwide developed MDR-TB where patient does not respond to the two most powerful anti-TB drugs isoniazid and/or rifampicin.

Culture which is the reference method for detection, requires at least a turn-around time of between 2 and 10 weeks & then again testing for these anti-TB drugs will take another few weeks. New WHO recommendations aim to speed up detection and improve treatment outcomes for MDR-TB through use of a molecular diagnostic test.

Test Overview

TRUPCR® Rif/INH Drug Resistant MTB Detection Kit is designed for accurate identification of Mycobacterium tuberculosis complex (MTC) along with Rifampicin and Isoniazid resistance/susceptible status from various sources of clinical samples using Real time nested PCR.

This assay utilizes four different tubes where one tube specifically detects MTC whereas another three tubes detects MDR. For detection of MDR, five different probes are used each of which binds to a different target segment within 81-bp core region of rpoB gene and one each for katG gene and promoter region of inhA gene. Each test is a multiplex reaction where targets are detected through FAM/Green, Hex/Yellow/VIC and/or Tex Red/Orange/ROX channels.

Technical Specifications

• Sample Type – Sputum, BAL, Pus, CSF, Aseptic fluid, Aseptic tissue, Urine and Other fluids samples of human origin  
• Clinical Validation – Validated on more than 500 clinical samples
• Target Regions – For MTBC: IS-6110 and MPB64
• For Rifampicin resistance: rpoB gene (81 base pair conserved regions)
• For Isoniazid resistance: katG and inhA gene
• Reaction Volume – 30µl in each tube
• LOD Data: 120 CFU/ml of sputum.
• Compatible Instruments – Applied Biosystems™ 7500 series, Applied Biosystems™ StepOne series, Applied Biosystems™ QuantStudio® series, Rotor-Gene Q, Bio-Rad CFX96, CFX384, AriaMx Real-Time PCR, Roche - LightCycler® 480 –II, Line gene K Real-Time PCR