NEW DEKHI: The government, on Sunday, said that the National Institute of Virology, Pune under the Indian Council of Medical Research has successfully developed the first indigenous anti-SARS-CoV-2 human IgG ELISA test kit 'Covid Kavach Elisa' for antibody detection for Covid-19.
The development of the kit is crucial as it can help the governments and epidemiologists understand the extent of the population exposed to the virus in all zones of the country.
The kit has been validated at 2 sites in Mumbai and has high sensitivity and accuracy, said Union Health Minister Harsh Vardhan adding that the government has already transferred the technology to pharmaceutical major Zydus Cadila for mass-scale production of the kits.
The Drug Controller General of India has approved the mass production and the kits could be available for use in states as early as next week.
"We had developed the test about a week back but were waiting for validation and now that it has come through, we are looking to roll it at the earliest," a source in the health ministry told this newspaper.
The test, according to Union ministry of health and family welfare can test up to 90 samples together in a single run of 2.5 hours, so that healthcare professionals can proceed quickly with necessary next steps on their patients’ triage paths.
These tests are easily possible even at the district level as the ELISA kit has inactivated virus and there are also minimal bio-safety and bio-security requirements as compared to the real-time RT-PCR test. The only reliable testing method available in the country as of now which can be used only for clinical diagnosis of infected patients.
Epidemiologists underlined the significance of the breakthrough saying that the ELISA based testing kit has come at the 'right time'.
"It will help the country ramp up the testing process and understand the actual status of virus spread across districts," said Dr Giridhara R Babu, professor and head, lifecourse epidemiology at IIPH, Public Health Foundation of India, Bengaluru.
"Also since this test can detect antibody IgG in individuals- even those who caught the infection several days back and would have recovered completely can be caught."
Sources in the ICMR and the health ministry meanwhile said that while an expert panel on surveillance has advised carrying out sentinel survey on individuals from 400 high risk and low risk population each in 80 districts, final guidelines will soon be issued to states on the population surveillance for virus exposure.
The Centre's earlier bid to introduce rapid antibody testing kits in India had failed earlier as 5.5 lakh kits procured from two Chinese companies had turned out to be negative--much to the embarrassment of the health ministry and the ICMR.