COVID-19 antibodies test developed and validated in India! The Indian Council of Medical Research (ICMR), which is the nodal agency spearheading the fight against COVID-19 pandemic in India, has issued a statement saying that its National Institute of Virology (NIV) in Pune have successfully developed as well as validated the entirely indegenous IgG ELISA for the detection of the antibodies against SARS-CoV-2, the virus which causes COVID-19.
The statement said that on external validation, the test kit was found to be 98.7% sensitive and 100% specific. ICMR further stated that ELISA test can process 90 samples in a single run, which lasts for two and a half hours.
Furthermore, according to the statement, the ELISA-based test can even be held at the district level easily since the kit has inactivated virus.
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Moreover, this test also requires minimal biosecurity and biosafety measures as compared to the RT-PCR test.
Explaining the importance of antibody tests like ELISA, the statement said that while RT-PCR tests are the frontline tests to clinically diagnose the presence of SARS-CoV-2, such antibody tests are important for surveillance, with the purpose of understanding the proportion of population exposed to the disease.
The statement further announced that post the development of the lab in NIV, Pune, four major companies – SPAN, J MITRA, Zydus-Cadila and Cipla – were invited to take up the production of the kits, but only Zydus-Cadila accepted to produce the test, which has been named ‘COVID KAVACH ELISA’.
ICMR has signed a non-exclusive agreement of the production of the kits with Zydus-Cadila, which means that ICMR has the authority to offer any other company/companies the production opportunity of the IgG test.
ICMR also announced that the first batch of ELISA tests produced by Zydus-Cadila has been validated by NIV and similar sensitivity and specificity standards were found even in this batch.