Ortho’s VITROS SARS-CoV-2 Antigen Test for high volume COVID-19 testing receives CE Mark

April 14, 2021 – Ortho Clinical Diagnostics (Raritan, NJ) announced it received CE Marking for its VITROS SARS-CoV-2 Antigen Test, initially launched in October 2020.

The company says that receipt of CE Mark allows for more convenient sample collection and expanded viral transport media.

“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.”

Updates to Ortho’s COVID-19 antigen test include:

  • More Convenient Sample Collection
  • Additional Viral Transport Media (VTM)
  • New Sensitivity Data

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.

Ortho’s SARS-CoV-2 Antigen Test is the latest addition to the company’s COVID-19 solutions, which include two COVID-19 antibody tests — Total and IgG — both of which have U.S. Food and Drug Administration (FDA) Emergency Use Authorization and CE Mark.

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