DCGI OK’s 1st ‘Made-in-India’ TB kit

| | New Delhi
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DCGI OK’s 1st ‘Made-in-India’ TB kit

Wednesday, 07 December 2022 | Pioneer News Service | New Delhi

With Mylab’s PathoDetect kit patients can with a single test know their active TB infection as well as drug resistance to 2 most common drugs - Isoniazid and Rifampicin - so that they take treatment that will actually work. 

The first ‘Made in India’ kit recently approved by the DCGI, TB expert panel under the ICMR has been developed by Mylab. The kit is a RT-PCR 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 Prime Minister’s vision to eliminate TB by 2025 from India, said Hasmukh Rawal, the MD of Mylab.

He explained that the device will help address several problems simultaneously. It can not only do multiple tests at one time but also does not need highly technical people which we are already short of to handle samples and reagents, he added.

The kit has been approved after rigorous and large scale field trials and recommended by the TB Expert Committee under ICMR.

“Multicentre centre evaluation study and field feasibility testing studies were carried out for the “PathoDetect MTB RIF and INH drug resistance kits” & Compact device systems. The centres of trials included the most reputed Tb research centres of India, which evaluated the performance of the kit against the currently used diagnostic assays for Tuberculosis,” said Rawal.

He further said, “There is a huge problem of resistance to drugs when it comes to TB. Until now, India had to conduct 2 tests: one to detect TB first and to check drug resistance – that against only one drug (Rifampicin). But with Mylab’sPathoDetect™ kit, the test pattern will be changed.”

Also, the test kits have been designed to work in ambient temperatures compared to existing PCR options which need 2-8 degree cold storage. Mylab Compact™ device systems do not require special infrastructure for operations and feasibility studies done on mobile vans in rural areas indicate them to be very robust.

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