First academic institute to get approval for a real-time polymerase chain reaction-based model
IIT Delhi said it has got the approval from the Indian Council for Medical Research (ICMR) for a probe-free coronavirus detection assay developed by it.
The institute, in a statement on Thursday, said the assay had been validated at ICMR with a sensitivity and specificity of 100%, making IIT-D the first academic institute to have obtained ICMR approval for a real-time polymerase chain reaction (PCR)-based diagnostic assay.
The assay was developed by researchers at IIT Delhi’s Kusuma School of Biological Sciences (KSBS).
“Using comparative sequence analyses, the IIT Delhi team identified unique regions (short stretches of RNA sequences) in the COVID-19/SARS COV-2 genome. These regions are not present in other human coronaviruses, providing an opportunity to specifically detect COVID-19,” the statement read.
It added that the method used primers targeting unique regions of COVID-19 that were designed and tested using real-time PCR.
“These primers specifically bind to regions conserved in over 400 fully sequenced COVID-19 genomes. This highly sensitive assay was developed by extensive optimization using synthetic DNA constructs followed by in-vitro generated RNA fragments,” it further read.
The research team said the assay would 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 team said.
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