Ortho's CE-Marked VITROS SARS-CoV-2 Antigen Test Detects Asymptomatic COVID-19 Individuals

Ortho Clinical Diagnostics (Raritan, NJ, USA) has announced that its CE-marked VITROS SARS-CoV-2 antigen test can now detect SARS-CoV-2 infection in asymptomatic individuals.

The low-cost VITROS antigen test can run up to 130 tests per hour and is able to detect SARS-CoV-2 infection in individuals who do not report any symptoms, making it a viable choice for frequent, high-throughput testing and monitoring of large community populations including health care workers, schools, sporting organizations, manufacturing facilities, assisted and institutionalized living, and other communities. Ortho's antigen test is offered with 92.3% sensitivity with samples with a cycle threshold (CT - a measure of viral load) count of less than 30. Samples with CT values of 30 or greater are less likely to contain live virus that are capable of replicating in cell cultures, suggesting less infectivity.


The VITROS SARS-CoV-2 Antigen test is the first test to run on Ortho's high-throughput, fully automated VITROS platform using respiratory specimens, 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, and stored at room temperature for up to 24 hours or 48 hours if refrigerated. Contrary to PCR tests, which can take hours to obtain results, Ortho's COVID-19 antigen test can run on the company’s high-throughput 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.

"Cases of COVID-19 continue to rise globally, yet there remains significant need for reliable testing and faster results reporting due to the lack of availability, high expense and infrastructure challenges of polymerase chain reaction (PCR) testing," said Chris Smith, chairman and chief executive officer, Ortho Clinical Diagnostics. "Ortho's antigen test enables accurate, frequent mass testing of both symptomatic and asymptomatic individuals at a lower cost than PCR. By using analyzers already in place across the world, the test can be instrumental in controlling the spread of the disease."