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An indigenous diagnostic test used in detecting drug-resistant tuberculosis, TrueNat, has been validated for confirmatory detection of SARS-COV2 virus by the Indian Council of Medical Research.
Earlier, ICMR had given nod to use TrueNat only as a screening test and insisted on running a reverse transcriptase polymerase chain reaction (RT-PCR) test in lab setting for confirmation. TrueNat was only testing for E gene on the sample, which is common for both SARS virus as well as SARS-COV2 which causes Covid-19.
“A positive test indicated presence of the Sarbeco subgenus of the beta coronavirus family. Now, we have added a confirmatory test with the RdRp gene which confirms SARS-COV2. Only those samples which are positive in screening need to progress to confirmatory test,” a top official from Molbio Diagnostics, which offers TrueNat test, told Businessline. Molbio has already supplied three lakh testing kits for screening tests to the Centre.
Awaiting DCGI approval
“We will also supply confirmatory test kits, which can be used on the same TrueNat platform, depending on demand. These kits are manufactured in India. We are now awaiting approval from Drug Controller General of India (DCGI) to start manufacturing,” the official said.
While the screening test costs close to ₹1,200, the confirmatory test will also be similarly priced, according to Molbio.
TrueNat test is offered by Goa-based Molbio, in collaboration with the Central TB Division (CTD) of Ministry of Health and Family Welfare to provide infrastructure for TB tests. “The States have up to 367 machines (majority of which are in Andhra Pradesh), while 500 more machines are being procured,” said a senior official from MoHFW.
While India is conducting over one lakh RT-PCR tests a day, TrueNat will be an additional tool that would provide on-demand testing, said the Molbio official. “TrueNat serves as a point-of-care test at primary health centre or block level hospitals, and is already being used for screening Covid-19 patients. Now it has been validated by ICMR to conduct confirmatory tests as well. This will enhance government’s capacities to test at the grassroots,” he said.
In a letter to all States last month, the CTD has said that it has placed purchase orders for TrueNat Covid-19 chips to help ramping up the testing capacity, using TrueNat platforms available under the National TB Elimination Programme.
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