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Ortho Clinical Diagnostics launches two COVID-19 antibody tests with 100 per cent specificity

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The tests can identify with high accuracy previously infected patient who can donate antibody-containing plasma to treat severe COVID-19 patients, any inaccurate test result could lead to plasma therapy without antibodies to SARS-CoV-2, active ingredients in convalescent plasma therapy

With 65,35,354 confirmed cases worldwide and 3,87,155 deaths due to the novel coronavirus scourge —2,36,657 cases / 6,642 deaths in India — healthcare professionals, researchers and government officials in the country and across the globe are racing against the clock to find solutions to better manage COVID-19 and save more lives and families. ICMR has asked states to conduct antibody tests on large scale.

Study results show that even with 97 per cent specificity, there is a chance of getting 30 false positive results out of 1,000 and with 99.6 per cent, four false positive results out of 1,000. Only with 100 per cent specificity can one be fully confident that the antibody positive test result is a true positive.

Ortho’s high-throughput, automated VITROS Anti-SARS-CoV-2 antibody tests have demonstrated 100 per cent specificity in assay validation studies. The tests can help to identify with high accuracy a previously infected patient who can donate antibody-containing plasma to treat severe COVID-19 patients. This is important because any inaccurate test result could lead to a plasma therapy without antibodies to SARS-CoV-2, the active ingredients in the convalescent plasma therapy.

Both VITROS Anti-SARS-CoV-2 antibody tests target the S1 subunit of the Spike (S) protein of SARS-CoV-2. The virus uses the S1 protein to bind to the angiotensin-converting enzyme 2 (ACE2) receptor to facilitate viral entry and infection.  Antibodies that can bind to S1 and block S1-ACE2 interaction can inhibit viral infection, which are called neutralising antibodies. The VITROS Anti-SARS-CoV-2 antibody tests can detect neutralising antibodies that bind to the S1 protein. 

Ortho’s 100 per cent specificity-compliant antibody assay for COVID-19 testing — the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total and IgG Reagent Packs and Calibrators — have now been included in the updated list of approved Rapid / CLIA / ELISA kits the Central Drugs Standard Control Organisation (CDSCO), under the Ministry of Health and Family Welfare, GoI. 

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