Roche gets green signal for COVID-19 antibody test

A health worker takes a sample from a man testing for the COVID-19 in Srinagar. Picture/AFP

Roche Diagnostics India on Monday said it welcomed Indian Council of Medical Research's communication regarding its COVID-19 antibody test for seroprevalence studies in India.

Dr Shravan Subramanyam, Managing Director, Roche Diagnostics India said, "Roche Diagnostics India welcomes ICMR's communication that cites making available Roche COVID-19 antibody test for seroprevalence studies in India."

According to Subramanyam, 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. 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."

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