An RT-PCR test kit developed by a company based in Pune and Michigan in the US has been found capable of detecting all coronavirus strains while specifically differentiating between the Delta and Omicron variants, the company said on Monday.
“This evaluation by PKC (Pune Knowledge Cluster) demonstrates the ability of the GenePath test kit to accurately differentiate between samples with the Delta vs the Omicron, leading to a lower burden on the very accurate but expensive and slower next-generation sequencing machines,” said Dr Nickhil Jakatdar, CEO of GenePath Diagnostics, which developed the kit called GenePath Dx CoviDelta RT-PCR test.
The test kit, which uses multiple, distinct markers across the coronavirus genome to increase sensitivity and resilience to emerging mutations in the virus, is capable of detecting all strains of the virus with high sensitivity. “One of these markers (the Delta-Omicron on-off marker) is a unique target in the virus’s s-gene, which enables rapid presumptive identification of the Delta and Omicron samples using the World Health Organization-recommended S-gene target amplification and S-gene target failure approaches in tandem,” the company said.
Dr. Nikhil Phadke, founder and chief scientific officer of the company, said the test kit would help doctors make better decisions now that the variants information would be available at the time of diagnosis itself. The single-tube kit has already been approved by the Indian Council for Medical Research and the Central Drugs Standard Control Organisation.
The Pune Knowledge Cluster, established by the government, has a long-standing partnership with the company, according to Dr Phadke. It coordinates many projects dealing with Covid-19 through leading Pune-based institutions–such as the Council for Scientific and Industrial Research’s National Chemical Laboratory (NCL), the Indian Institutes of Science Education and Research (IISER) and BJ Government Medical College–where genome sequencing of the coronavirus takes place. It is through this partnership that the first Omicron case in Pune was identified in record time.
Professor LS Shashidhara, principal investigator at the PKC, said that tests carried out at the IISER and the CSIR-NCL, suggested GenePath Diagnostics’ RT-PCR kit would be a valuable addition to healthcare providers’ armour.