ICMR nod for Bengaluru kit that tests for COVID-19 in 1 hour

Considered a potential game-changer in testing COVID-19 cases, the TrueNAT machine that can test COVID-19 samples in just one hour, has obtained an approval from ICMR. Developed by Bengaluru-based Molbio Diagnostics in Rajajinagar, it beats conventional PCR (polymerase chain reaction) machines which take six to seven hours. The company developed India's first diagnostic kit for swine flu during the 2015 outbreak. Its battery-operated TrueNAT machines for testing Tuberculosis is already being used in 225 community health centres in Andhra Pradesh. Now, with a new feature added to TrueNAT, the TrueNAT Beta CoV test, can test a sample for COVID-19 in one hour.

However, unlike Andhra Pradesh, which already has the machines and only has to purchase if it wishes to test COVID-19 with it, Karnataka uses around 65 US-made Cepheid's GeneXpert machines to test TB. Dr C N Manjunath, nodal officer for COVID-19 lab testing said, "We have to reinvest in the machines which cost Rs 6 lakh to Rs 12.5 lakh. We could have gone for these machines at districts which have none."

Dr Chandrashekhar Nair, co-founder, Molbio, said, "Goa has GeneXpert machines too. But they have bought five machines and now extensive screening for COVID-19 is under way. There is no comparison with GeneXpert as we can test for TB, COVID-19 and Nipah (for which it has a test licence) with the same machine and different cartridges." The machine can test for 18 other viruses including KFD with its upcoming PCR tests which are under development.

Around 800 TrueNAT machines are in use in the public and private sectors across India. The Union government is buying 1,500 machines for TB testing.

The Virology Department of National Institute of Mental Health and Neurosciences (Nimhans) had helped Molbio develop the H1N1 diagnostic kit. Dr V Ravi, HoD, Virology, Nimhans, said, "The ICMR approval came only yesterday. If the ICMR has approved it, it has to be a good test. The TrueNAT machine is an instrument the size of a domestic telephone in which we load a sample into a cartridge that looks like a pen drive." TrueNAT is battery-operated and hence can be used anywhere, not just a lab. Each test is priced at Rs 1,350.

"It can be a throat swab or a nasal swab collected in a virus transport medium. A portion of the medium is added to the chip, which is put into the machine. It extracts genetic material and then it does the PCR. All the reagents are in the form of a gel and put on a small strip. So, when it is put into the machine, the reagents will melt and the PC reaction will start and you can read the result in one hour," Ravi said.

If the machine is a four-bay one, in one hour, four samples can be tested. "The advantage is that it can be run several times continuously. The big technology difference here is the underlying principle of both the traditional PCR machine and TrueNAT is PCR but it has been miniaturised in a small box. In a regular PCR machine, one can run, 24 or 40 or 96 samples at a time, but the RNA has to be extracted separately. Here, they have combined everything," he said.