Ortho's VITROS SARS-CoV-2 Antigen Test for High-Volume Testing Receives FDA EUA for New Performance, Sensitivity Data

Ortho Clinical Diagnostics (Raritan, NJ, USA) has received authorization from the US Food and Drug Administration 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 US.

Authorized for use in the US in January 2021, Ortho's VITROS SARS-CoV-2 Antigen Test offers reliable detection of SARS-CoV-2 in patients suspected of COVID-19 by their healthcare provider within seven days of the onset of symptoms with high sensitivity and specificity. 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, bolstering the ability of hospitals and reference labs to address testing backlogs, supply shortages, and delayed results that have undermined previous testing efforts. 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.


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 30. 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. 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.

Testing leaders 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, which is readily available and cost effective, 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.

"Communities and laboratories across the United States continue to seek fast, reliable, simplified diagnostic solutions to help them tackle the volume of COVID-19 tests needed to aid safe reopening measures," said Chockalingam Palaniappan, PhD, chief innovation officer, Ortho Clinical Diagnostics. "Ortho Clinical Diagnostics continues to innovate to provide them with solutions - including our antigen test with new performance and sensitivity data, that enable fast, high-volume testing with accurate results."