HiMedia is seeking approval from the CDSCO and will launch the kits once approved
HiMedia Laboratories and Syngene International have collaborated to manufacture ELISafe 19, an IgG based ELISA test kit for COVID-19 now approved by the Indian Council of Medical Research (ICMR).
The ELISafe 19 antibody test kit reportedly has has a sensitivity of 100 per cent and specificity of 99 per cent and will be launched once HiMedia receives approval from the Central Drugs Standard Control Organisation (CDSCO).
Syngene developed the IgG based ELISA at its research facility in Bengaluru while HiMedia manufactured and commercialised the product.
The IgG antibody test is used to study and understand the percentage of population exposed to SARS-CoV-2 infection. The ELISafe 19 kit is intended for qualitative detection of IgG SARS-CoV-2 antibodies using the standard ELISA method on human serum/plasma samples. 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.
Appreciating the prompt response of the ICMR in reviewing and approving the ELISafe 19 kit Dr Vishal Warke, Director R&D, cell culture and immunology, HiMedia Laboratories, commented that the kit is made in India for the benefit of Indian hospitals and patients and it would play a significant role in testing for SARS-CoV-2 antibodies facilitating tracking of the progression of infection and immunity to future infection.
Highlighting the urgent need for simple and specific testing tools that not only detect the presence of the coronavirus but also contribute to the surveillance of the immune response to the virus, Dr Mahesh Bhalgat, COO, Syngene International said that the ELISafe 19 testing kit fills this gap, with this type of serological detection of SARS-CoV-2 antibodies generating invaluable data and providing the basis for epidemiological studies of immunity in the community, which would be a “significant advance in the management of this highly infectious disease in India.”