Syngene International and HiMedia Laboratories, which have collaborated to manufacture ELISafe 19, an IgG based ELISA test kit for Covid-19, have received the approval by the Indian Council of Medical Research (ICMR). The product will be launched once it receives approval from the Central Drugs Standard Control Organisation (CDSCO) next.
The test kits, developed indigenously by Biocon’s research arm Syngene, test the presence of SARS-COV-2 antibodies which confirm that a patient has been exposed to the coronavirus. It has a capacity to test samples together in a single run and generates results within three hours.
“We appreciate the prompt response of the ICMR in reviewing and approving the ELISafe 19 kit. The kit is a result of a unique combination of skills: Syngene’s expertise in viral research and HiMedia’s ability to manufacture and commercialise the product,” said Vishal G Warke, Director R&D, Cell Culture and Immunology, HiMedia Laboratories.
The kit will also help to identify the IgG immune status of Covid-19 recovered patients so that their plasma can be used for therapeutics.
“This type of serological detection of SARS-CoV-2 antibodies will generate invaluable data and provide the basis for epidemiological studies of immunity in the community: a significant advance in the management of this highly infectious disease in India,” said Mahesh Bhalgat, Chief Operating Officer, Syngene International.