Ortho Clinical Diagnostics (OCDX) VITROS SARS-CoV-2 Antigen Test for High-Volume COVID-19 Testing Receives CE Mark

Ortho Clinical Diagnostics (Nasdaq: OCDX), one of the world's largest pure-play in vitro diagnostics companies, today announced it received CE Marking for its VITROS® SARS-CoV-2 Antigen Test, initially launched in October 2020. The 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 CollectionWhen 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.
• Additional Viral Transport Media (VTM)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.
• New Sensitivity DataThe VITROS® SARS-CoV-2 Antigen Test now demonstrates 98 and 92.3 percent sensitivity (nasopharyngeal and nasal, respectively) for samples with a PCR cycle threshold (Ct— an assessment of viral load), of less than 30. Studies 1,2 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.

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