Mylab has received CDSCO, TB Expert Committee and ICMR approval for Made in India TB Detection kit to detect Tuberculosis (TB), which also simultaneously detects multiple drug resistance to Rifampicin and Isoniazid in single test.
The kit is named PathoDetect MTB RIF and INH drug resistance kit. It is a RTPCR based kit for accurate detection and will be used with Mylab Compact device systems which will allow completely automated testing of multiple samples within 2 hours. This will be instrumental in supporting the honourable Prime minister’s vision to eliminate TB by 2025 from India.
Hasmukh Rawal, MD, Mylab said, “We are addressing several problems simultaneously here. First being able to speed up testing by automated systems that can do multiple tests at one time. Secondly, there is scarce trained manpower for RT-PCR testing, which India can now overcome with fully automated system which does not need highly technical person to handle samples and reagents.”
The kit has been approved after large scale field trials and recommended by TB Expert Committee under the aegis of ICMR. Multicentre evaluation study and field feasibility testing studies were carried out for the “PathoDetect MTB RIF and INH drug resistance kits” & Compact device systems.
The test kits have been designed to work in ambient temperatures compared to existing PCR options which need 2-8 degree cold storage.
