The CoviDelta diagnostics kit developed indigenously by Pune-based GenePath Diagnostics has been approved by the Indian Council of Medical Research (ICMR), company sources said on Friday. The kit detects all current variants of COVID-19 and flags presumptive Delta and Omicron variants in a single test, said Dr. Nickhil Jakatdar, CEO, GenePath Diagnostics.
“This kit is capable of detecting all important COVID-19 variants described across the world to date, including the currently dominant Delta and Omicron variants. This made-in-India kit is quick and cost effective and has been approved by the ICMR as being able to detect COVID-19 variants with high sensitivity and specificity,” he said.
Dr. Nikhil Phadke, founder and chief science officer at GenePath Diagnostics, said that the ‘CoviDelta kit’ helped flag the presence of the first Omicron case in Pune city, which was subsequently confirmed by the Union Health Ministry’s Indian SARS-CoV-2 Genomics Consortium (INSACOG).
“Several government and private organisations in India and internationally are now evaluating the use of this kit as part of their diagnostic and surveillance efforts,” Dr. Phadke said.
According to him, the most significant highlight of the test kit is its ability to reliably differentiate all current Delta and Omicron lineages, including BA.1, BA.2 (also known as the “Omicron-like” or “stealth” variant), and the very recently proposed BA.3 lineage.
“All Omicron lineages share a number of common defining mutations. The BA.2 sub-lineage, however, does not carry the spike gene mutations and hence will not be detected by the so-called ‘S-gene target failure’ (SGTF) approach followed by other commercial kits that are currently being used for the purpose,” said Dr. Phadke.
He added that a large percentage — as high as 70% — of recently sequenced cases primarily from South Africa, Australia and Canada, reportedly belonging to the BA.2 sub-lineage had failed to be detected by the aforementioned SGTF approach.
“GenePath’s CoviDelta kit, however, targets the downstream Spike L452R mutation which is present in the ‘Delta’ lineage but absent in all the Omicron sub-lineages,” Dr. Phadke said.
Maharashtra has till date reported more than 30 Omicron cases, the highest number in the country so far.