Covid-19: ICMR clears ELISA antibody testing kits
In another step towards rolling out domestically manufactured antibody test kits for a national Covid-19 household survey, the Indian Council of Medical Research (ICMR) has approved the first batch manufactured by Zydus-Cadila.
The test kits, called "COVID KAVACH ELISA", were developed at the National Institute of Virology in Pune, isolating the virus from patients in India earlier this week.
According to an ICMR official, the ELISA kits will be used in the Ministry of Health's new national "sero-survey", aimed at detecting the prevalence of antibodies that appear after a patient has recovered. The ICMR will lead the testing of 24,000 people in 69 districts at the household level as part of this serological survey.
The Council stated in a statement: “While real-time RT-PCR is the first-line test for the clinical diagnosis of SARS-CoV-2, robust antibody testing is critical for surveillance to understand the proportion of population exposed to infection.
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ELISA antibody tests are different from the rapid antibody tests previously used by the Indian authorities. The WHO has called ELISAs "highly sensitive and specific" tests that are suitable for "analyzing a large number of samples per day, as well as in blood banks or for surveillance studies."
While only Zydus-Cadila had previously agreed to a non-exclusive agreement to produce the test kits, ICMR stated that “ICMR has now been approached by Cipla Pvt. Ltd. and NextGen Life Sciences.”