Chennai: Roche Diagnostics India announced the launch of its antibody test SARS-CoV-2 test – Elecsys Anti-SARS-CoV-2 S.
A press release said, the test is CE IVD approved and has received ICMR and CDSCO approval in India.
It is an in vitro test that quantifies antibodies against the receptor-binding domain (RBD) of spike (S) protein SARS-CoV-2 in human serum and plasma, and determines the body’s immune response to the virus.
Narendra Varde, MD, Roche Diagnostics India, said, “The newest antibody solution, Elecsys Anti-SARS-CoV-2 S, will not only give a ‘positive’ or ‘negative’ result, but also will provide a numerical result to indicate the concentration of SARS-CoV-2 specific antibodies in the blood, further supporting the healthcare systems and patients as we jointly fight Covid-19”.
Dr Sandeep Sewlikar, head of Medical and Scientific Affairs – Roche Diagnostics India, pointed out the need for an antibody test for India by stating, “The test has both a high clinical specificity of 99.98 per cent (N=5991) and sensitivity of 98.8 per cent (N=1423), 14 days or later after diagnosis with PCR. The result is provided in the form of an antibody concentration (U/mL)”.