Ortho Clinical Diagnostics, Raritan, NJ, announced that the 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 enhanced 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% sensitivity[i] 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,” says 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, NY, and will soon scale up production in Pencoed, UK. The test will be available worldwide in large volumes beginning in early November 2020.

For more information, visit Ortho.

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.

Featured image: The Vitros SARS-CoV-2 Antigen test runs on the Vitros XT 7600 Integrated System, pictured. (Courtesy: Ortho Clinical Diagnostics)


[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