Ortho's VITROS SARS-CoV-2 Antigen Test for High-Volume COVID-19 Testing Receives CE Mark

Ortho Clinical Diagnostics (Raritan, NJ, USA) has received CE Marking for its VITROS SARS-CoV-2 Antigen Test, allowing for more convenient sample collection and expanded viral transport media.

Initially CE Marked in October 2020, 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 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.


Following the CE Marking, personnel at hospitals, reference labs, and other healthcare settings utilizing Ortho's antigen test will now be able to use a nasal sample which is more convenient than the nasopharyngeal swab specimen collection method. Laboratories 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 existing 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.

"Regions across the world are in various stages of reopening and recovering, yet there remains a great need for reliable tests that can be performed quickly and in bulk to ensure the continued safety of these 'back-to-normal' measures," said Chockalingam Palaniappan, PhD, chief innovation officer, Ortho Clinical Diagnostics. "Ortho's customers continue to trust its COVID-19 testing solutions—including the updated antigen test—to efficiently meet the demand for accurate mass testing and fast, trusted results."