The cobas SARS-CoV-2 Qualitative assay is a single-well dual target assay that enables both specific detection of SARS-CoV-2 and pan-sarbecovirus detection
Roche Diagnostics building in Rotkreuz. (Credit: F. Hoffmann-La Roche Ltd)
Swiss healthcare company Roche has received the US Food and Drug Administration (FDA) 510(k) approval for the cobas SARS-CoV-2 Qualitative PCR test to be used on the company’s fully automated cobas 6800 and cobas 8800 Systems.
The standalone test is intended for the qualitative detection of SARS-CoV-2 in nasal and nasopharyngeal samples from symptomatic patients, who are suspected of having Covid-19.
It has been available in the US under Emergency Use Authorization (EUA) since March 2020 and was the first commercial test to receive the EUA status.
Roche Diagnostics CEO Thomas Schinecker said: “Roche is fully committed to continuing our support and innovation for Covid-19 diagnostics to address evolving healthcare needs and to help keep communities safe.
“We are actively working with health authorities to pursue FDA-cleared status for the tests in our Covid-19 portfolio. This will ensure clinicians and patients have continued access to accurate, reliable and efficient testing options.”
The cobas SARS-CoV-2 Qualitative assay is a single-well dual target assay that enables both specific detection of SARS-CoV-2 and pan-sarbecovirus detection.
Its FDA approval is supported by a comprehensive package submitted to the US agency, including analytical and clinical studies.
The real-time RT-PCR test is intended to be performed by qualified clinical laboratory personnel, specifically trained for real-time PCR and the use of cobas 6800/8800 Systems.
Roche’s cobas 6800/8800 Systems are designed to enhance operating efficiency, flexibility, and rapid time-to-results, delivering test results within three and half hours.
The systems can provide up to 96 results in around three hours, with a total of 1,440 results for the cobas 6800 System and 4,128 results for the cobas 8800 System within 24 hours.
Furthermore, the cobas 6800/8800 Systems allows the test to be performed simultaneously with other assays offered by the Swiss firm.
Earlier this month, Roche rolled out three next-generation range SARS-CoV-2 rapid antigen tests (2.0) for professional use and self-testing in countries accepting the CE Mark.
The SARS-CoV-2 Rapid Antigen Test 2.0 and SARS-CoV-2 Rapid Antigen Test 2.0 Nasal are meant for professional use, while the SARS-CoV-2 Antigen Self-Test Nasal is for self-testing, said the Swiss company.