Ortho's VITROS® SARS-CoV-2 Antigen Test for High-Volume COVID-19 Testing Receives CE Mark; Allows for More Convenient Sample Collection and Expanded Viral Transport Media
RARITAN, N.J., April 13, 2021 /PRNewswire/ -- 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:
About the VITROS® SARS-CoV-2 Antigen Test
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 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.
About Ortho's VITROS® COVID-19 Testing Solutions
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.
Because Ortho's VITROS Systems are already installed worldwide, reporting times may be further improved because lab staff require no additional training, and the instruments are already connected to existing laboratory information systems and software. These systems are self-contained and do not require an external water source to run.
Questions from laboratories, health care providers, or government officials regarding Ortho's COVID-19 solutions can be directed to: OrthoCOVID19Test@orthoclinicaldiagnostics.com. For more information visit: https://www.orthoclinicaldiagnostics.com/global/covid19/.
About Ortho Clinical Diagnostics
Ortho Clinical Diagnostics (Nasdaq: OCDX) is one of the world's largest pure-play in vitro diagnostics (IVD) companies.
More than 800,000 patients across the world are impacted by Ortho's tests each day. Because Every Test is a Life™, Ortho provides hospitals, hospital networks, clinical laboratories and blood banks around the world with innovative technology and tools to ensure test results are fast, accurate, and reliable. Ortho's customized solutions enhance clinical outcomes, improve efficiency, overcome lab staffing challenges and reduce costs.
From launching the first product to determine Rh+ or Rh- blood type, developing the world's first tests for the detection of antibodies against HIV and hepatitis C, introducing patented dry-slide technology and marketing the first U.S. Food and Drug Administration-authorized high-volume antibody and antigen tests for COVID-19, Ortho has been a pioneering leader in the IVD space for over 80 years.
The company is powered by Ortho Care™, an award-winning, holistic service and support program that ensures best-in-class technical, field and remote service and inventory support to laboratories in more than 130 countries and territories around the globe.
1 Viral cultures for COVID-19 infectivity assessment. Systematic review. Tom Jefferson, Elizabeth Spencer, Jon Brassey, Carl Heneghan. medRxiv 2020.08.04.20167932; doi: https://doi.org/10.1101/2020.08.04.20167932.
2 N Engl J Med 2020;382:2081-90. DOI: 10.1056/NEJMoa2008457
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SOURCE Ortho Clinical Diagnostics
Company Codes: NASDAQ-NMS:OCDX