Raritan-based Ortho Clinical Diagnostics said April 3, it is launching to market its COVID-19 antibody test.
The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack testing kits are expected to be available in a few weeks.
“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,” said Chris Smith, chief executive officer. “At Ortho Clinical Diagnostics, the patient is at the heart of everything we do—because we believe behind every test is a life.”
In a statement, Ortho said it followed guidelines established by the U.S. Food and Drug Administration’s Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency.
The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack detects antibodies (including IgG and IgM) to COVID-19 that can be used to detect immune response to the virus.
The test may be used in epidemiological research to help better understand the spread of the disease and may also be used to aid in the diagnosis of suspected COVID-19 patients in conjunction with molecular tests.
“Ortho leveraged its history of innovation and history of advancing through science to quickly develop these solutions,” said Chockalingam Palaniappan, chief innovation officer. “It’s inspiring to think of the good the health care community can do by advancing the learning about this virus.”
The test will run on Ortho’s flagship analyzer, the VITROS XT 7600 Integrated System, the VITROS 3600 Immunodiagnostic System, the VITROS 5600 Integrated System and VITROS ECi/ECiQ Immunodiagnostic Systems and can process approximately 150 tests in an hour.
The systems are designed to remove barriers and are adaptable for non-traditional laboratory environments because they don’t require an external water supply to run.
Ortho said they are already installed in more than 1,000 hospital and reference labs throughout the United States.
“Given the incredible demand for information to change the tide of this pandemic, Ortho felt it was necessary to market as quickly as possible with a notification to the FDA,” said Smith. “We are working to make our antibody test kit available to the areas with the greatest need first and will be working in parallel to both increase our test kit production and follow additional regulatory pathways to secure further approvals.”