The firm said that the test is the first automated real-time RT-PCR assay for in vitro qualitative and quantitative detection of SARS-CoV-2 RNA in nasal and nasopharyngeal swab specimens
Roche secures FDA EUA for cobas SARS-CoV-2 Duo PCR test. (Credit: Michael Kretzschmar from Pixabay)
Swiss healthcare company Roche has received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its cobas SARS-CoV-2 Duo.
The test is intended for use on the fully automated cobas 6800/8800 Systems, expanding the Roche COVID-19 portfolio.
The firm said that the test is the first automated real-time RT-PCR assay for in vitro qualitative and quantitative detection of SARS-CoV-2 RNA in nasal and nasopharyngeal swab specimens.
The cobas SARS-CoV-2 Duo test combines a regular SARS-CoV-2 PCR test’s standard qualitative result with a quantitative result that evaluates the viral load of a patient suspected of Covid-19 infection.
It also aims to help the healthcare community with contact tracing, patient triage and the approach to medical care.
Roche Diagnostics CEO Thomas Schinecker said: “With the SARS-CoV-2 Duo test, we are now able to detect the Covid-19 virus and simultaneously measure the viral load in an individual.
“The test’s performance suggests that, by earlier and more accurately identifying infected patients, the results may open the path for healthcare providers to more efficiently organise their therapeutic and monitoring interventions.”
Roche said that the quantitative result can be compared to the SARS-CoV-2 RNA International Standard set by the World Health Organization (WHO).
The advantages of reporting a standardised viral load in addition to the qualitative result could aid doctors in the assessment and monitoring of infected patients between laboratories and over time.
Roche is committed to fighting against Covid-19 by adding a variety of diagnostic tools to its global portfolio.
The test will be available in the US by the second quarter of 2022.