in vitro diagnostics company, Ortho Clinical Diagnostics has announced that the U.S. FDA has accepted its Emergency Use Notification (EUN) for the new VITROS® SARS-CoV-2 Antigen test. Designed to detect active SARS-CoV-2 infection the test had earlier gained its CE Mark, allowing distribution throughout the European Union.
Background
All these months into the pandemic, testing for COVID-19 continues to challenge scientists and politicians. Current testing is both slow to process and can suffer a high rate of false positives. The real-time polymerase chain reaction (PCR) test with cycle thresholds of above 30 is able to pick up fragments of viral RNA which may be residual and not live. These patients are highly unlikely to be infectious.
Ortho’s newly accepted test represents a viable alternative to PCR testing for individuals with known or suspected exposure to SARS-CoV-2 or who are displaying symptoms suggestive of viral infection. The test is offered with 100 percent sensitivity with samples with a CT count of less than 34. As such it may be better able to identify individuals with COVID-19 who are infectious
Ortho’s SARS-CoV-2 antigen test claims exceptional utility for mass-scale testing where appropriate. The VITROS SARS-CoV-2 Antigen test is the first test to run on Ortho’s high-throughput, fully automated VITROS® platform from swabs. The self-contained systems do not require an external water source to run, making them suitable for locations that may not have accessible plumbing. Most importantly they are capable of processing up to 130 antigen samples per hour.
Ortho manufactures its SARS-CoV-2 antigen test in Rochester, New York, and will soon scale up production in Pencoed, U.K. The test will be available worldwide in large volumes beginning in early November 2020.
The VITROS SARS-CoV-2 Antigen test is the latest addition to Ortho’s COVID-19 testing solutions. Ortho also manufactures two COVID-19 antibody tests—Total and IgG—which were granted Emergency Use Authorization by the FDA in April and achieved CE Mark in May. With more than 5,600 Ortho immunodiagnostic systems currently in operation worldwide, millions of COVID-19 tests can be processed per day.
Company comments
“At Ortho, we never stop innovating. As COVID-19 cases continue to rise across the globe, Ortho is working to bring to market COVID-19 solutions that help labs meet an ever-growing testing demand and best serve their communities with high-quality, accurate, cost-effective tests that run at high volumes,” said Chris Smith, chairman and chief executive officer, Ortho Clinical Diagnostics.
Source: PR Newswire
published: November 6, 2020 in: Approval/Clearance, COVID-19, News