Ortho Clinical Diagnostics, a US-based vitro diagnostics company, is set to launch its SARS-CoV-2 COVID-19/coronavirus antibody test under the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack.

The company plans to release testing kits to the US market in a few weeks.

Ortho Clinical Diagnostics said that it had adhered to the guidelines set by the US Food and Drug Administration’s (FDA) Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency.

Commenting on the coronavirus antibody test, Chris Smith – CEO of Ortho Clinical Diagnostics said: “The unprecedented nature of this rapidly spreading virus required an immediate response from the diagnostics industry, and Ortho followed through on its commitment to help develop better ways to treat patients and provide robust data to help manage COVID-19.

“At Ortho Clinical Diagnostics, the patient is at the heart of everything we do—because we believe behind every test is a life.”

According to the vitro diagnostics company, the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack detects antibodies, including IgG and IgM, to SARS-CoV-2 that can be used for detecting an immune response to the virus.

The test can be used in epidemiological research to help better understand the spread of coronavirus and could also be used to help in diagnosing suspected patients in conjunction with the COVID-19 molecular tests.

Chockalingam Palaniappan – chief innovation officer of Ortho Clinical Diagnostics, commenting on the coronavirus antibody test, said: “Ortho leveraged its history of innovation and history of advancing through science to quickly develop these solutions.

“It’s inspiring to think of the good the healthcare community can do by advancing the learning about this virus.”

The new coronavirus antibody test will run on the flagship analyzer of Ortho Clinical Diagnostics – VITROS XT 7600 Integrated System, the VITROS 3600 Immunodiagnostic System, the VITROS 5600 Integrated System and VITROS ECi/ECiQ Immunodiagnostic Systems and can process nearly 150 tests in an hour.

Ortho Clinical Diagnostics said that its systems are designed to eliminate barriers and are adaptable for non-traditional laboratory environments as they don’t need an external water supply to run and are installed already in over 1,000 hospital and reference labs across the US.

  Chockalingam Palaniappan, Chris Smith, Coronavirus, COVID-19, Ortho Clinical Diagnostics, USA