The premier science research institution under Union Science and Technology Ministry Sree Chithira Tirunal Institute for Medical Sciences and Technology (SCTIMST) said on Thursday that it developed a diagnostic kit substitute for time- consuming real time PCR test which it said it is cheaper and more accurate.
SCTIMST director Dr Asha Kishore said it is the first substitute for Real Time PCR test and it is a path-breaking development as the country is struggling with mounting cases of the novel coronvirus.
“Validation of our kit was done by the National Institute of Virology centre in Alappuzha as directed by the ICMR. It is cheaper, faster and maintains international standards. Now ICMR can include it in the list of approved tests in the country. Distinction between negative and positive graphs was superior to standard PCR,” she said.
Called ‘Chitra Gene LAMP N’ scientists of Thiruvananthapuram-based institute said it is highly confirmatory for the diagnosis of Covid-19 and detects the N-Gene of the SARS CoV 2 using reverse transcriptase loop-mediated amplification of viral nucleic acid (RT-LAMP). This will be one of world’s first few, if not the first, confirmatory diagnostic test for N gene of SARS-CoV-2 using the RT-LAMP technique, they said.
The test kit which is specific for SARS-CoV-2 N-gene 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, they said. The new kit allows confirmation in one test without the need for a screening test and at much lower costs, they said.
{{/usCountry}}The test kit which is specific for SARS-CoV-2 N-gene 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, they said. The new kit allows confirmation in one test without the need for a screening test and at much lower costs, they said.
{{/usCountry}}The director said in new kit the gene detection time is 10 minutes and the sample to result time (from RNA extraction in swab to RT LAMP detection time) will be less than 2 hours. At least 30 samples can be tested in a single batch in a single machine and the lower machine waiting time will allow large number of samples to be tested each day in a single machine in multiple shifts.
The testing facility can be set up even in the labs of district hospitals with limited facilities and trained technicians. The results can be read from the machine from the change in fluorescence. The new device for LAMP testing costs ₹2.5 lakh and the test kit for 2 regions of N gene( including RNA extraction) will be less than ₹1000 test when RT PCR machine is 15-40lakh) and PCR kit test is between ₹1900 and 2500, scientists said.
The SCTIMST said 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 and his team developed the kit in 3 weeks. It said it will waive the licence fee to encourage industry which takes up its technology for mass manufacture to meet the immediate needs. The Institute said it will invite expressions of interest from firms for transfer of technology to start large scale production.