March 24, 2021 – Ortho Clinical Diagnostics (Raritan, NJ) has received authorization from the U.S. Food and Drug Administration (FDA) to update key claims for the VITROS SARS-CoV-2 Antigen Test, the first high-volume SARS-CoV-2 antigen assay to receive Emergency Use Authorization (EUA) in the United States.
The VITROS SARS-CoV-2 Antigen Test demonstrates 94.8% sensitivity for samples with a PCR cycle threshold (CT— an assessment of viral load), of less than 301.
According to the company, studies have shown that samples with PCR CT values at 30 – 33 or greater carry little to no live virus, suggesting these patients may no longer be infectious. Ortho says that this further solidifies the test’s clinical utility in identifying individuals who are in the acute stage of COVID-19 infection when the risk for viral transmission is the highest.
When utilizing Ortho’s antigen test, personnel at hospitals, reference labs, and other healthcare settings will now be able to use a nasal sample which is more convenient than the nasopharyngeal swab specimen collection method. Further, the authorization allows for easier and faster sample collection.
Users will now be able to utilize three additional viral transport media (VTM) options. Designed to preserve the integrity of collected samples during transportation to laboratories, new VTM options authorized for use with the VITROS SARS-CoV-2 Antigen Test include Saline, or Phosphate Buffered Saline (PBS), Bartels FlexTrans transport media [Trinity Biotech], and the World Health Organization’s formulation of VTM, in addition to the CDC’s formulation of VTM, COPAN Universal Transport Media (UTM), and Hardy R99 VTM—expanding options and testing capacity for customers who use Ortho’s antigen assay.
With utility for mass-scale testing and same-day results for labs, Ortho’s antigen test can be processed at a rate of up to 130 tests per hour on a single analyzer.
The company says that the VITROS SARS-CoV-2 Antigen Test also offers a practical and cost-effective testing alternative to polymerase-chain reaction (PCR) tests, which, while highly accurate, can be expensive and require long processing times during testing surges.