Thiruvananthapuram, Apr 16 () The Sree ChitraTirunal Institute for Medical Sciences and Technology(SCTIMST) here has developed a much cheaper and fasterdiagnostic test kit (Chitra Gene LAMP-N) which is highlyconfirmatory for the diagnosis of COVID-19 that has claimedover 400 lives in the country.
The test kit can detectthe "N Gene of SARS COV2 usingreverse transcriptase loop-mediated amplification of viralnucleic acid (RT-LAMP). We are not aware of anybody else in the world doing lampfor N gene for corona virus, Institute Director," Dr AshaKishore told .
This technology is much cheaper, faster, can check 100per cent matching with PCR (Polymerase chain reaction) andaccuracy. It will be very easy to deploy it across thecountry, being very cost effective, she said.
"This will be one of worlds first few if not the firstconfirmatory diagnostic test for N gene of SARS-CoV-2 usingthe RT-LAMP technique.
The test kit which is highly specific for SARS-CoV-2N-gene can detect two regions of the gene which will ensurethat the test does not fail even if one region of the viralgene undergoes mutation during its current spread," a pressrelease from the institute said.
The institute has informed theIndian Council ofMedical Research (ICMR) about the test kit and is awaitingapproval.
Using Chitra Gene LAMP-N, the gene detection time is10 minutes and the sample to result time (from RNA extractionin swab to RT LAMP detection time) will be less thantwo hours,she said, adding 30 samples can be tested in asingle batch in a single machine.
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The significantly lower machine waiting time will allowlarge number of samples to be tested each day in a singlemachine in multiple shifts, she said.
The kit was developed by a team led by Dr AnoopThekkuveettil, a senior Scientist of the Biomedical Technologywing of the Institute and scientist-in-charge of the divisionof molecular medicine under the Department of AppliedBiology,in the last three weeks.The new device for LAMP testing costs around Rs 2.5lakh and the test kit for two regions of N gene(including RNAextraction) will be less than Rs 1000/test, while the RT PCRmachine costs around Rs 15 lakh to Rs 40 lakh and the PCR kitcost is Rs 1900-2500/test.
The testing facility can be easily set up even in thelaboratories of district hospitals with limited facilities andtrained laboratory technicians,Dr Asha said.
The institute had developed the technologyfordetection of TB-Bacteria in 2018-19 and was awaitingmulti-centreclinical trials in India in March 2020, when thecoronavirus struck.
Dr Asha said it was thenthey decided to see ifthis technology could be used for detecting coronavirus.
It took them only 14 daysas most of the technologywas validated and kept, only the organism was different,shesaid.
"We had to design the primer RNA.The micro organism isdifferent-- one was a bacteria, while COVID-19 was a virus."
The Microbiology department developed the primers topick up the RNA of the virus.
Certain things had to be re-done to make sure thegene would pick up the same technology by the primers designedhere, she said.
The technology was transferred for manufacture toAgappe Diagnostics Ltd, based in Ernakulam, a leading companyin In vitro diagnostics with national and internationaloperations, and an already established partner of theInstitute in the segment of in vitro diagnostics.
According to her, with the validation results fromNIV, Agappe Diagnostics will applyto Central Drugs StandardControl Organisation (CDSCO) for license to manufacture thekits.
The company has already applied for funding from theDST's Technology Development Board for manufacture.
The Institute has also allowed waiver of the licensefee to encourage any industry which takes its technologies tomanufacture such products to meet the immediate needs of thecountry. RRT UD BNWELCOME BNWELCOME
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