A limited quantity of tests kits have already been shipped to areas of highest priority. Ortho will be in full production in the coming weeks and plans to manufacture several million SARS-CoV-2 antibody tests over the next month, with rapid production expansion following thereafter.
Following Ortho's April 3 launch of the test under the FDA's notification pathway for serology tests, Ortho further worked with the FDA to secure additional review of the data under its Emergency Use Authorization pathway, which allows the FDA to expedite review and authorization of SARS-CoV-2 diagnostic tests to rapidly expand testing capacity during the COVID-19 public health emergency.
The VITROS® Anti-SARS-CoV-2 antibody tests are designed and solely intended to be performed by laboratory professionals and cannot be directly used by patients as they are not for home use.
Questions from laboratories, healthcare providers, government, or media regarding the COVID-19 antibody test can be directed to: OrthoCOVID19Test@orthoclinicaldiagnostics.com. For more information visit: https://orthoclinical.info/34FEPue.
*High Throughput: If an instrument has high throughput, it can output a large number of test results in a short period of time. When running infectious disease tests such as our COVID-19 tests, Ortho's instruments can process up to 150 tests per hour.
If an instrument is fully automated, it doesn't require a lab employee to perform each test by hand. Instead, each patient tube is loaded in bulk into the instrument, and the instrument automatically mixes the patient sample with test solutions. The ensuing chemical reaction provides the patient result. That result is automatically sent to the hospital's laboratory information systems and ultimately, the physician.
About Ortho Clinical Diagnostics
Ortho Clinical Diagnostics is a global leader of in vitro diagnostics dedicated to improving and saving lives through innovative laboratory testing and blood-typing solutions.
Because Every Test is a Life™, we never stop innovating to offer streamlined, sustainable laboratory solutions that deliver fast, accurate, reliable test results that support exceptional patient care.
As a trusted partner of hospitals, hospital networks, blood banks, and labs around the world, we proudly serve the clinical laboratory and transfusion medicine communities with customized solutions that enhance clinical outcomes, improve lab performance, overcome staffing challenges and better manage costs.
