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FDA Authorizes Roche’s COVID-19 Test that Can Detect Viral Load

The automated, RT-PCR assay allows in-vitro qualitative and quantitative SARS-CoV-2 RNA detection.

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By: Sam Brusco

Associate Editor

Roche has gained U.S. Food and Drug Administration (FDA) emergency use authorization (EUA) for its cobas SARS-CoV-2 Duo for use on the fully automated cobas 6800/8800 Systems.
 
The automated, RT-PCR assay allows in-vitro qualitative and quantitative SARS-CoV-2 RNA detection in nasal and nasopharyngeal swab specimens.
 
“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,” Thomas Schinecker, CEO of Roche Diagnostics told the press. “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 organize their therapeutic and monitoring interventions.”
 
Reporting a standardized viral load along with the qualitative result can help clinicians assess and monitor infected patients across labs and over time. The test will be available by the end of Q2.

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