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ICMR approves TB machines for Covid-19 testing

Maitri Porecha New Delhi | Updated on April 04, 2020 Published on April 04, 2020

ICMR will procure seven lakh US FDA-EUA/CE-IVD/ICMR-NIV Pune-approved RNA extraction kits. Representative image   -  Bloomberg

Diagnostic machines used to test drug-resistant tuberculosis (TB) have now been approved by Indian Council of Medical Research (ICMR) for conducting Covid-19 tests.

“ICMR has recommended use of Truenat beta CoV test on Truelab workstation validated by ICMR as a screening test. Also, use of US-FDA approved closed real time Polymerase Chain Reaction (RT-PCR) systems like GeneXpert and Roche Cobas - 6800/800 have been approved under emergency use,” ICMR has stated in its guidance.

A top executive from Molbio diagnostics which manufactures Truenat told Businessline that the company already has over 800 Truenat machines in place across India primarily for use in detecting drug-resistant TB, of which close to 400 were in government set-ups. Out of which 257 are in Andhra Pradesh alone, at district and sub-district level.

Truenat

While GeneXpert is a cartridge-based technology, Truenat is smaller, battery operated, requires minimal training and is usable even in smaller settings such as the Primary Health Centre. It uses a chip-based technology and takes just up to 60 minutes for a test, screening or confirmatory.

“While the testing platform that was being used for TB remains the same, we need to equip these centres with Covid-19 testing kits. In a four-way Truenat machine, one can run up to 32 to 48 samples of multiple diseases - COVID19, HIV and TB. We just have to feed in the respective test profile in the machine and it can process multiple diseases at one time,” the executive said.

Of the 800 machines, 150 to 200 machines are two-way and can handle 16 to 24 samples, there are about 50 four-way machines and rest of them are single-way machines, which can process 8 to 12 samples at a time. The cost of a test on Truenat will be ₹1,000-₹1,500, the executive said. This is a fifth of what it costs today. While Molbio wants to expand its manufacturing capacity and place more machines on ground, the executive said that they were awaiting for the government directives on the number of machines and tests needed in each state.

“We are in close touch with states to scale up our manufacturing capacities as also for supplying testing kits. Once the throat and nasal swab sample is safely collected by trained technicians wearing personal protective equipment, it is rendered non-infectious in the machine and results are obtained between 30 and 60 minutes,” the executive said.

One big concern is India’s inability to manufacture local kits. “We are mostly dependent on imports from the US or other countries for acquiring kits,” said the executive.

Published on April 04, 2020

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