The Thiruvananthapuram-based Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST) has developed a diagnostic test kit (Chitra GeneLAMP-N), tipped as highly confirmatory for the diagnosis of COVID1-9 and detects the N Gene of SARS-COV2 using reverse transcriptase loop-mediated amplification of viral nucleic acid (RT-LAMP). SCTIMST functions under the Department of Science and Technology, Govt of India.
The new test kit is said to be one of the world’s first few, if not the first confirmatory, diagnostic test for N gene of SARS-CoV-2 using the RT-LAMP technique. SCTIMST sources said, the test kit is highly specific for SARS-CoV-2 N-gene, and can detect two regions of the gene. This ensures that the test does not fail even if one region of the viral gene undergoes mutation during its current spread.
The NIV-Alappuzha was authorized by ICMR to validate the tests and test license was sanctioned by CDSCO. The tests performed at NIV-Alappuzha found Chitra GeneLAMP- N to show 100% accuracy and 100% congruence with test results using RT-PCR. This has been intimated to ICMR. The next step is the approval of Chitra GeneLAMP- N by ICMR for COVID-19 testing in India and License from CDSCO for manufacture.
The Centre for Disease Control, USA, recommends detection of 2 regions of N-gene for confirmation of COVID-19 by any gene amplification technology. Abbott Corporation, of the US, recently developed RdRp gene detection in COVID-19 using LAMP technique. Eiken Chemical CO. Ltd, Japan has also used LAMP technique but not for N gene. Current PCR kits in India enable detection of E gene for screening and RdRp gene for confirmation. Chitra GeneLAMP-N gene testing will allow confirmation in one test without the need for a screening test and at much lower costs.
Using Chitra Gene LAMP-N, 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. As many as 30 samples can be tested in a single batch in a single machine and the significantly lower machine waiting time will allow large number of samples to be tested each day in a single machine in multiple shifts, the sources said.
The testing facility can be easily set up even in the laboratories of district hospitals with limited facilities and trained laboratory technicians. The results can be read from the machine from the change in fluorescence. The new device for LAMP testing (Rs 2.5 Lakhs) and the test kit for 2 regions of N gene( including RNA extraction) will be less than Rs 1000/test for the laboratory when RT PCR machine (15-40lakh) and PCR kit (Rs 19002500/test) to the laboratory.
Sree Chitra has also additionally developed the specific RNA extraction kits along with GeneLAMP-N test kits and the testing device. The research and development of Chitra GeneLAMP-N was fully funded by Department of Science and Technology, Govt of India. The technology was transferred in for manufacture to Agappe Diagnostics Ltd, Ernakulam, a leading company in In vitro diagnostics with national and international operations, and an already established partner of the Institute in the segment of in vitro diagnostics.
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 the last 3 weeks. The same team of Sree Chitra had already developed a test kit and a highly sensitive device using the LAMP technique the detection of DNA of Mycobacterium tuberculosis from sputum samples of patients with suspected lung TB in 2018-2019 and the technology was transferred The kit and device developed by Dr Anoop Thekkuveettil for TB diagnosis were scheduled for a multi-centre clinical trial across the country in March 2020, with the support of ICMR.
The TB detection device development was a project was funded under the technical research centre for biomedical devices program of the DST and the current research is an extension of the LAMP technique for the detection of SARS-COV2 N gene.
With the validation results from NIV, Agappe Diagnostics Ltd, Ernakulam, will apply to CDSCO for license to manufacture the kits. The company has already applied for funding from the Technology Development Board of DST for manufacture. The Institute has allowed waiver of the license fee to encourage any industry which takes its technologies to manufacture to meet the immediate needs of the country. The Institute will now invite expressions of interest from other companies for transfer of technology to enable large scale production across the country in a short time.
The Institute expressed its gratitude to the govt of Kerala and the officials of the Kerala state disaster management authority for facilitating the transport of key reagents for the R&D work from Karnataka during the lock down period.