A method to detect COVID-19 which will significantly reduce the cost of testing, making it affordable for a large population in the country, developed by Indian Institute of Technology, Delhi has got the approval from the ICMR, officials said on Thursday.
IIT Delhi is the first academic institute to have obtained the ICMR approval for a real-time PCR-based diagnostic assay. The development also comes against the backdrop of the Indian Council of Medical Research halting the testing for COVID-19 cases through China-made test kits because of massive variation in test results, compounding the challenge to check and contain the pandemic.
The current testing methods available are "probe-based" while the one developed by the IIT team is a "probe-free" method, which reduces the testing cost without compromising on accuracy, officials
"The test method has been approved by ICMR. The assay has been validated at ICMR with a sensitivity and specificity of 100 per cent. This makes IITD the first academic institute to have obtained ICMR approval for a real-time PCR-based diagnostic assay," a senior official said.
"This is the first probe-free assay for COVID-19 approved by ICMR and it will be useful for specific and affordable high throughput testing. This assay can be easily scaled up as it does not require fluorescent probes. The team is targeting large scale deployment of the kit at affordable prices with suitable industrial partners as soon as possible," the official added.
Using comparative sequence analyses, the IITD team identified unique regions (short stretches of RNA sequences) in the COVID-19 and SARS COV-2 genome.
RNA or Ribonucleic Acid is one of the major biological macromolecules that is essential for all known forms of life. It performs various important biological roles related to protein synthesis such as transcription, decoding, regulation and expression of genes.
"Using comparative sequence analysis, we have identified unique regions in COVID-19. These unique regions are not present in other human coronaviruses providing an opportunity to specifically detect COVID-19," said Professor Vivekanandan Perumal, lead member of the team.
"Primer sets, targeting unique regions in the spike protein of COVID-19, were designed and tested using real time polymerase chain reaction. The primers designed by the group specifically bind to regions conserved in over 200 fully sequenced COVID-19 genomes. The sensitivity of this in-house assay is comparable to that of commercially available kits," he added.
The team at IIT claims that their test can be performed at a much cheaper cost and hence will be affordable for general public.
The research team includes PhD scholars Prashant Pradhan, Ashutosh Pandey and Praveen Tripathi, post-doctoral fellows Drs Parul Gupta and Akhilesh Mishra and professors Vivekanandan Perumal,
Manoj B Menon, James Gomes and Bishwajit Kundu.