Trivandrum-based government institute Sree Chitra Tirunal Institute for Medical Sciences and Technology has developed a diagnostic test kit that can deliver COVID-19 testing results in just two hours at a low cost of Rs 1,000.
The test called Chitra GeneLAMP-N uses the reverse transcriptase loop-mediated amplification of viral nucleic acid (RT-LAMP) for testing.
This is different from the popular testing methodology called RT-PCR for COVID-19. Current PCR kits in India enable detection of E gene for screening and RdRp gene for confirmation.
Chitra GeneLAMP-N gene testing will confirm the result in one test without any need for a screening test and at much lower costs.
It can take a total of 30 samples in a single batch in a single machine allowing a large number of samples to be tested each day.
The cost of testing with this new device will be less than Rs 1,000 per test for the laboratory and the testing facility can be easily set up even in the laboratories of district hospitals with limited facilities and trained laboratory technicians.
The tests performed at NIV Alappuzha (authorized by ICMR) show that Chitra GeneLAMP- N has 100 per cent accuracy and it matches with test results using the popular testing methodology called RT-PCR for COVID-19.
Funded by Department of Science and Technology, the test kit is made especially for SARS-CoV-2 N-gene and can detect two regions of the gene, which will ensure that the test does not fail even if one region of the viral gene undergoes mutation during its current spread, ensuring a high possibility of accurate test results.
The test kit was developed by the team led by Anoop Thekkuveettil, a senior Scientist of the Biomedical Technology Wing of the Institute in the last three weeks.
The results now are with the concerned authority for approval following which licence will be required from CDSCO to start manufacturing these kits.
Sree Chitra has also additionally developed the specific RNA extraction kits along with GeneLAMP-N test kits and testing devices.
The LAMP testing devices costs Rs 2.5 lakhs and the test kit for two regions of N gene costs less than Rs 1000 per test. In comparison, the RT PCR machine costs anywhere between Rs 15-40 lakh and the PCR kit costs Rs 2000-Rs 2500 per test.
The technology has been transferred for manufacturing to Agappe Diagnostics, Ernakulam-based firm that provides in-vitro diagnostics.
"Development of a novel, inexpensive, rapid confirmatory for the diagnosis of COVID-19 by Sree Chitra in record time is a compelling example of how a creative team of clinicians and scientists working together seamlessly can leverage knowledge and infrastructure to make relevant breakthroughs," said Prof Ashutosh Sharma, Secretary, DST.
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