According to an ICMR official, the ELISA kits will be used in the Health Ministry’s new nationwide “sero-survey”, meant to detect prevalence of antibodies that appear after a patient has recovered. (File Photo)
In another step towards deploying antibody testing kits manufactured in the country for a nationwide household Covid-19 survey, the Indian Council of Medical Research (ICMR) has approved the first batch manufactured by Zydus-Cadila.
The test kits, called “COVID KAVACH ELISA”, was developed at the National Institute of Virology, Pune, by isolating the virus from patients in India earlier this week.
According to an ICMR official, the ELISA kits will be used in the Health Ministry’s new nationwide “sero-survey”, meant to detect prevalence of antibodies that appear after a patient has recovered. The ICMR will lead the testing of 24,000 individuals in 69 districts at household level as part of this sero-survey.
The ICMR says the first manufactured batch of ELISA kits has a sensitivity (accurate positive test results) of 98.7 per cent and a specificity (accurate negative test results) of 100 per cent.
The Council stated in a release, “While real-time RT-PCR is the frontline test for clinical diagnosis of SARS-CoV-2, robust antibody tests are critical for surveillance to understand the proportion of population exposed to infection.”
ELISA antibody tests are different from the rapid antibody tests previously used heavily by Indian authorities. The WHO has called ELISAs “highly sensitive and specific” tests that are suitable for “for testing large numbers of samples per day, as well as in blood banks or for surveillance studies”.
While only Zydus-Cadila had earlier accepted a non-exclusive agreement to produce the test kits, ICMR stated that “now, ICMR has been approached by Cipla Pvt. Ltd. and NextGen Life Sciences”.