The Indian Council of Medical Research (ICMR) has validated IgG Elisa kits of three companies — Gujarat-based Zydus Cadila Healthcare Ltd, Euroimmun US Inc and Calbiotech Inc, both from the USA to conduct sero-survey to measure Covid-19 exposure in the vulnerable population like healthcare workers, frontline workers and people living in containment zones.
The IgG ELISA kits are the first indigenous antibody detection kits for coronavirus.
Zydus had licensed the Covid Kavach Elisa IgG test kit developed by the ICMR. The medical research body had earlier claimed that its test kit has an impressive 100 per cent specificity and 98 per cent sensitivity.
Three batches of ‘Covid Kavach ELISA IgG kits’ developed by Zydus Cadila Healthcare Ltd, one batch of Euroimmun Anti- SARS-COV-2 ELISA IgG by Euroimmun US Inc, USA, and a batch of Erbalisa Covid-19 IgG ELISA manufactured by Calbiotech Inc, USA have been approved.
The ICMR said “responsibility for batch to batch consistency lies with the manufacturer”.
“Depending upon the level of sero-prevalence of infection, matching public health interventions can be implemented for prevention and control of the disease,” the research body said.
Further, it should be used for survey in high-risk or vulnerable populations like healthcare workers, frontline workers, immune-compromised individuals, individuals in containment zones, to know who have been infected in the past and have now recovered.
The ICMR has also provided details of seven pharma companies to whom it has transferred the technology to undertake the production of indigenous Covid Kavach ELISA IgG kits which help in the antibody detection for Covid-19. These test kits have the advantage of testing 90 samples in a single run of 2.5 hours so that healthcare professionals can proceed quickly with the necessary next steps.
“The ELISA tests have been validated in the laboratory. However, the performance of the test may be subject to variation under field conditions,” the ICMR added.
The IgG ELISA/CLIA tests which are US-FDA approved can be used directly after due marketing approval from the Drugs Controller General of India (DCGI).