Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, an Institute of National Importance, of the Department of Science and Technology (DST), has developed a diagnostic test kit that can confirm COVID19 at low cost within 2 hours.
The confirmatory diagnostic test, which detects the N gene of SARS-COV2 using reverse transcriptase loop-mediated amplification of viral nucleic acid (RT-LAMP), will be one of the first in the world, if not the first of its kind.
The test kit, funded by the DST called Chitra GeneLAMP-N, is very specific to the SARS-CoV-2 N gene and can detect two regions of the gene, ensuring that the test does not fail even if one region of the viral gene undergoes mutation during its current distribution.
The tests performed at NIV Alappuzha (authorized by ICMR) show that Chitra GeneLAMP-N has 100% accuracy and matches test results using RT-PCR. This has been communicated to ICMR, the authority to approve, for COVID-19 testing in India, after which the manufacturing license must be obtained from CDSCO.
Current PCR kits in India allow detection of E gene for screening and RdRp gene for confirmation. Chitra GeneLAMP-N gene tests will allow confirmation in one test without the need for a screening test and at a much lower cost.
The detection time is 10 minutes and the sample that should yield the time (from swab RNA extraction to RT-LAMP detection time) will be less than 2 hours. A total of 30 samples can be tested in a single batch in a single machine, allowing a large number of samples to be tested daily.
“The development of a new, low-cost, rapid confirmatory diagnosis of COVID1-9 by Sree Chitra in record time is a compelling example of how a creative team of clinicians and scientists who work seamlessly together can leverage knowledge and infrastructure to drive relevant breakthroughs. from a Technology Research Center at SCTIMST and four other DST institutions have delivered rich dividends by turning basic research into key technologies, “said Prof. Ashutosh Sharma, DST Secretary.
The test facility can even be easily set up in the laboratories of district hospitals with limited facilities and trained laboratory technicians. The results can be read from the machine by the change in fluorescence. The cost of testing with the new LAMP testing device and the 2-region test kit of the N gene (including RNA extraction) will be less than Rs 1000 / test lab.
Sree Chitra has also developed the specific RNA extraction kits, along with GeneLAMP-N test kits and test equipment. The technology was transferred for manufacture to M / S Agappe Diagnostics Ltd, Ernakulam, a leading in vitro diagnostics company with national and international operations.
Dr. Anoop Thekkuveettil, a senior scientist from the Institute of Biomedical Engineering and responsible for the Molecular Medicine Department under the Department of Applied Biology, and his team have been developing the kit for the past 3 weeks.
(With inputs from PIB)