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


100 per cent 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.

Covid testing is at an all time high as India continues to reel under increasing incidence of positive Corona cases. Individuals who have recovered from Covid-19 can help in the treatment of Covid positive patients using Plasma therapy. It is therefore critical to be sure that only those individuals who have developed antibodies to SARs-CoV-2 be identified for therapy. Instances of faulty test reports can prove extremely fatal in such critical cases.  

100 per cent 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 per cent 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 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 Organization (CDSCO), under the Ministry of Health and Family Welfare, GoI.

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

‘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’, says Anand Pande, VP, A-Pac, Ortho Clinical Diagnostics

Ortho will be in full production mode in the coming weeks and plans to manufacture several million SARS-CoV-2 antibody tests over the next month

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