MUMBAI, 16 AUGUST, 2020 (GPN):

▪  Only with 100% specificity can one be fully confident that the antibody positive test result is a true positive, such as with the one developed and launched recently by Ortho Clinical Diagnostics. 

▪     Being 100% specificity-compliant, Ortho’sVITROS®Anti-SARS-CoV-2 Total and IgG tests can help identify, with great confidence, previously exposed individuals who have developed antibodies to SARS-CoV-2

Why 100% specificity is vital

Unlike many commercially available antibody test kits, Ortho’s high-throughput, automated VITROS® Anti-SARS-CoV-2 antibody tests are highly reliable and have demonstrated 100% specificity in assay validation studies. The tests can help 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.

New CDC guidelines

The recent guidelines from the Centre for Disease Control and Prevention (CDC) for Covid-19 antibody testing emphasizes on the serological methods/antibody testing towards monitoring and responding to the Covid-19 pandemic.

Ortho’s 100% 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 Organization (CDSCO), under the Ministry of Health and Family Welfare, GoI.

High throughput

o        The VITROS®analyzers (i.e. instruments) from Ortho can run up to 150 of these critical tests/hour

o        The COVID-19 antibody tests can be run on all Ortho’s flagship laboratory analyzers, the VITROS® XT 7600 Integrated System, the VITROS® 3600 Immunodiagnostic System and the VITROS® 5600 Integrated System

• Production plans

o        Ortho will be in full production mode in the coming weeks

o        It plans to manufacture several million SARS-CoV-2 antibody tests over the next month

About Ortho Clinical Diagnostics

▪     Ortho Clinical Diagnostics is a global leader of in vitro diagnostics, dedicated to saving and improving lives through innovative laboratory testing and blood-typing solutions- for the past 3 decades

▪     Ortho is powered by Ortho Care™, its global, award-winning, holistic approach to service

‘Long track record’

‘Our test kits have been approved by the CE and the U.S. FDA (EUA). They are widely used by prestigious hospitals and labs, such as Quest Labs, in the US. Our instruments are used for HIV, HBsAg and HCV screening across the world and the technology is being used for blood screening for more than 25 years in prestigious hospitals and blood banks in India and other SAARC countries’ ENDS