THIRUVANANTHAPURAM: Revolutionising the Covid-19 screening in the country, the Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST) has developed a test kit that will diagnose the disease in a single test at a much lower cost.
The test kit — Chitra GeneLAMP-N — now awaits the approval of Indian Council for Medical Research (ICMR) for Covid19 testing in India and licence from Central Drugs Standard Control Organisation (CDSCO) for manufacturing.
“ICMR had authorised the National Institute of Virology (NIV), Alappuzha, to validate the tests and the CDSCO had provided licence for the same. The test at NIV found that Chitra GeneLAMP-N showed 100 per cent accuracy and congruence with the RT-PCR results,” said SCTIMST director Asha Kishore.
The kit detects the N Gene of SARS-CoV-2 using reverse transcriptase loop-mediated amplification of viral nucleic acid. “Using Chitra GeneLAMP-N, gene detection can be done in 10 minutes and the sample-to-result time (from RNA extraction in swab to RT-LAMP detection time) will be less than two hours,” said Asha.
30 samples can be tested in a single batch
“Thirty samples can be tested in a single batch in a machine and the significantly lower machine waiting time will allow a large number of samples to be tested each day in a single machine in multiple shifts. The testing facility can be set up easily, even in the laboratories of district hospitals,” said Asha. The results can be read from the machine by noting the change in fluorescence.
SCTIMST has also developed the specific RNA extraction kits along with GeneLAMP-N test kits and the testing device. The research and development of Chitra GeneLAMP-N were fully funded by the Department of Science and Technology.
The technology has been transferred to M/S Agappe Diagnostics Ltd, Ernakulam -- a partner of the institute in the segment of in-vitro diagnostics -- for manufacture. It took only three weeks for the team led by the senior scientist Anoop Thekkuveettil of the institute’s Biomedical Technology Wing to develop the kit. The same team had earlier developed a test kit and a highly sensitive device using the LAMP technique for the detection of DNA of mycobacterium tuberculosis (TB) from sputum samples of patients with suspected lung TB in 2018-2019.
Awaiting ICMR nod
Chitra GeneLAMP-N now awaits ICMR approval for Covid-19 testing in India
It took only three weeks for the team led by senior scientist Anoop Thekkuveettil to develop the kit