Ortho's CE-Marked VITROS SARS-CoV-2 Antigen Test Detects Asymptomatic COVID-19 Individuals - Seite 2
For its VITROS SARS-CoV-2 Antigen test, Ortho achieved CE Mark on October 23, 2020, allowing test distribution throughout the European Union (EU). Ortho also submitted EUA and Emergency Use Notification (EUN) to the FDA on October 23, 2020. The FDA posted the Ortho SARS-CoV-2 antigen test on their website on October 30, 2020, allowing for distribution across the U.S. while the EUA is in review. The addition of asymptomatic claims is currently limited to the CE-Marked product while the FDA EUA review of Ortho's antigen test is ongoing.
The VITROS SARS-CoV-2 Antigen test is also the first test to run on Ortho's high-throughput, fully automated VITROS platform using respiratory specimens, rather than the blood and body fluid samples typically run by the systems. Samples for Ortho's SARS-CoV-2 antigen test can be collected in bulk, and stored at room temperature for up to 24 hours or 48 hours if refrigerated. Contrary to PCR tests, which can take hours to obtain results, Ortho's COVID-19 antigen test can run on Ortho's high-throughput VITROS Systems.
Ortho's SARS-CoV-2 antigen test runs on Ortho's VITROS XT 7600 Integrated System, the VITROS 3600 Immunodiagnostic System, and the VITROS 5600 Integrated System. An additional benefit to Ortho's VITROS Systems is that they are self-contained and do not require an external water source to run, making them suitable for myriad locations that may not have accessible plumbing.
The test, now commercially available, is manufactured in Rochester, New York.
Questions from laboratories, health care providers, or government officials regarding Ortho's COVID-19 solutions can be directed to: OrthoCOVID19Test@orthoclinicaldiagnostics.com. For more information visit: https://www.orthoclinicaldiagnostics.com/global/covid19/.
This project has been funded with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response under contract number 75A50120P00103.
The VITROS SARS-CoV-2 Antigen test has met the requirements for a diagnostic test cited in Section IV, Policy C in the following FDA Guidance: Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff --Document issued on the web on May 11, 2020. The VITROS SARS-CoV-2 Antigen test has been validated but the FDA's independent review of the labeling and validation is pending.