The Indian Council of Medical Research (ICMR) has given green signal to Roche Diagnostics India to carry out COVID-19 antibody test for seroprevalence studies in India.
Shravan Subramanyam, managing director, Roche Diagnostics India on Monday said, “Roche Diagnostics India welcomes ICMR’s communication that cites making available Roche COVID-19 antibody test for seroprevalence studies in India.”
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Subramanyam said the study includes those on high-risk groups like healthcare workers – to plan the country’s pandemic management efforts in the future.
The lab-based antibody test that runs on fully automated Chemiluminescence Immunoassay (CLIA) analysers with estimated peak testing capacity of 0.5 million tests a day is being made available across National Accreditation Board for Testing and Calibration Laboratories (NABL) approved and government sites in India.
The Elecsys Anti-SARS-CoV-2 serology test that supports detection of antibodies against SARS-CoV-2 has received the Import License issued by the Central Drug Standard Control Organization (CDSCO), due to the emergency health situation in the public interest.
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The test is CE IVD certified and has received USFDA emergency use authorisation (EUA).
Subramanyam said that this world-class COVID-19 antibody test is already deployed in UK, Singapore and other countries to test for COVID-19 antibodies.
“We are committed to explore public-private partnerships to build scale and thereby access to Roche COVID-19 antibody tests in India,” he said.