In a significant development for COVID-19 diagnosis and testing in India, a reputed medical institute in Kerala has been successful in developing a low-cost diagnostic testing kit that can give results of the viral infection in two hours.
A release from the Union Ministry of Science and Technology said Thursday that a team of clinicians and scientists at the Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST) in Thiruvananthapuram has been able to come up with a test kit which is deemed highly specific 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.
The test detects the N gene of SARS-COV2 using reverse transcriptase loop-mediated amplification of viral nucleic acid (RT-LAMP). Tests approved by the Indian Council of Medical Research (ICMR) at the NiV, Alappuzha have shown 100% accuracy and match with test results conducted using RT-PCR.
In recent weeks, companies including MyLabs in Pune have received approval from the ICMR to manufacture indigenous RT-PCR test kits that can give results in 2.5 hours. But, the one developed by Sri Chitra Tirunal institute can give faster results as well as allow confirmation in a single test without the need for a screening test.
The process from taking samples to getting results will take less than two hours and the detection time is just 10 minutes. As many as 30 samples can be tested in a single batch using a single machine, allowing for more samples to be tested per day.
Prof Ashutosh Sharma, secretary at the department of science and technology, said in a statement, “Development of a novel, inexpensive, rapid confirmatory for the diagnosis of COVID1-9 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. Establishment of a Technology Research Center at SCTIMST and four other DST institutions has brought rich dividends by conversion of basic research into important technologies.”
While current PCR tests allowed at private labs costs Rs 4500, the cost incurred for testing using the kit developed by SCTIMST will be less than Rs 1000. According to the release, the testing facility can be set up in laboratories of district hospitals.
The kit was developed by a team headed by Dr. Anoop Thekkuveettil, a senior scientist of the Biomedical Technology Wing of the Institute and Scientist-in -charge of the division of molecular medicine under the Department of Applied Biology in just three weeks. Now, formal approval needs to come from the ICMR following which license has to be obtained from CDSCO for manufacture.
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