U.S. FDA Accepts Ortho's Emergency Use Notification for VITROS® SARS-CoV-2 Antigen Test--Capable of Accurate Mass-Scale Testing
- Offered with 100 percent sensitivity[i] with samples with a PCR Cycle Threshold (CT) of less than 34, Ortho's test may be better able to identify individuals with COVID-19 who are infectious compared to PCR
- Ortho's new 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 CE Mark and FDA Emergency Use Authorization
RARITAN, N.J., Nov. 4, 2020 /PRNewswire/ -- Ortho Clinical Diagnostics, a global leader of in vitro diagnostics, today announced that the U.S. Food and Drug Administration (FDA) accepted the company's Emergency Use Notification (EUN) for the new VITROS® SARS-CoV-2 Antigen test, designed to detect active SARS-CoV-2 infection. On October 23, 2020, Ortho submitted an Emergency Use Authorization (EUA) request to the FDA and achieved CE Mark, allowing test distribution throughout the European Union (EU).
With high sensitivity and specificity,ii Ortho's SARS-CoV-2 antigen test offers exceptional utility for mass-scale testing where appropriate. Ortho's test is a viable alternative to real-time polymerase chain reaction (PCR) testing for individuals with known or suspected exposure to SARS-CoV-2 or who are displaying symptoms suggestive of viral infection. Studies iii,iv showed that samples with PCR cycle threshold (CT— a measure of viral load) levels at 30 - 33 or greater carry little to no live virus, suggesting these patients may no longer be infectious. Compared to PCR, Ortho's test may be better able to identify individuals with COVID-19 who are infectious because the test is offered with 100 percent sensitivity with samples with a CT count of less than 34.
"At Ortho, we never stop innovating. As COVID-19 cases continue to rise across the globe, Ortho is working to bring to market COVID-19 solutions that help labs meet an ever-growing testing demand and best serve their communities with high-quality, accurate, cost-effective tests that run at high volumes," said Chris Smith, chairman and chief executive officer, Ortho Clinical Diagnostics.
According to Smith, the VITROS SARS-CoV-2 Antigen test is the latest addition to Ortho's COVID-19 testing solutions. Ortho also manufactures two COVID-19 antibody tests—Total and IgG—which were granted Emergency Use Authorization by the FDA in April and achieved CE Mark in May. Millions of COVID-19 tests per day can be processed through the more than 5,600 Ortho immunodiagnostic systems currently in operation worldwide.
The VITROS SARS-CoV-2 Antigen test is also the first test to run on Ortho's high-throughput, fully automated VITROS® platform from swabs, rather than the blood and body fluid samples typically run by the systems. Samples for Ortho's SARS-CoV-2 antigen test can be collected in bulk, stored at room temperature for up to 24 hours or 48 hours if refrigerated, and contrary to PCR tests, which can take hours to obtain results, run on Ortho's high-throughput VITROS® Systems, which are capable of processing up to 130 antigen samples per hour.
Ortho's SARS-CoV-2 antigen test runs on Ortho's VITROS® XT 7600 Integrated System, the VITROS® 3600 Immunodiagnostic System, and the VITROS® 5600 Integrated System. An additional benefit to Ortho's VITROS Systems is that they are self-contained and do not require an external water source to run, making them suitable for myriad locations that may not have accessible plumbing.
Ortho manufactures its SARS-CoV-2 antigen test in Rochester, New York, and will soon scale up production in Pencoed, U.K. The test will be available worldwide in large volumes beginning in early November 2020.
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/.
This project has been funded with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response under Contract No. 75A50120P00103.
The VITROS SARS-CoV-2 Antigen test has met the requirements for a diagnostic test cited in Section IV, Policy C in the following FDA Guidance: Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff --Document issued on the web on May 11, 2020. The VITROS SARS-CoV-2 Antigen test has been validated but the FDA's independent review of the labeling and validation is pending.
The VITROS Anti-SARS-CoV-2 Total and IgG tests have not been FDA cleared or approved. They have been authorized by the FDA under an Emergency Use Authorization and testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate or high complexity tests. The VITROS Antibody tests have been authorized only for the detection of either Total or IgG antibodies from SARS-CoV-2, not for any other viruses or pathogens, and results should not be used as the sole basis for diagnosis. These tests are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
About Ortho Clinical Diagnostics
Ortho Clinical Diagnostics is a global leader of in vitro diagnostics dedicated to improving and saving lives through innovative laboratory testing and blood-typing solutions.
Because Every Test is a Life,™ we never stop innovating to offer streamlined, sustainable laboratory solutions that deliver fast, accurate, reliable test results that support exceptional patient care.
For more information about Ortho's solutions and services, visit Ortho's website or social media channels: LinkedIn, Twitter, Facebook, Instagram and YouTube.
i Sensitivity: (95% CI: 88.5- 100%)
ii Sensitivity (Days 1-6): 95.7% (95% CI: 85.5%–99.5%); Specificity: 99.2% (95% CI:95.4%–100.0%)
iii 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.
iv N Engl J Med 2020;382:2081-90. DOI: 10.1056/NEJMoa2008457
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