The Indian Council of Medical Research has released a validated list of IgG ELISA kits to be used for sero-surveys to understand the proportion of population exposed to COVID-19 including asymptomatic individuals.
The IgG ELISA kits are the first indigenous antibody detection kits for coronavirus.
The apex health research body has so far approved three batches of 'COVID Kavach ELISA IgG kits' developed by Zydus Cadila Healthcare Ltd, Ahmedabad, Gujarat.
Besides, one batch of Euroimmun Anti- SARS-COV-2 ELISA IgG manufactured by Euroimmun US Inc, USA, and a batch of Erbalisa COVID-19 IgG ELISA manufactured by Calbiotech Inc, USA have also been approved.
The Indian Council of Medical Research (ICMR) also mentioned the batch number, stating "responsibility for batch to batch consistency lies with the manufacturer".
The IgG ELISA tests are recommended for sero-surveys to understand the proportion of population exposed to the infection, including asymptomatic individuals.
"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 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).