Roche Diagnostics has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its cobas SARS-CoV-2 Qualitative PCR test.
The new real-time RT-PCR test has been designed for the qualitative detection of nucleic acids from SARS-CoV-2 in nasal and nasopharyngeal samples collected from symptomatic individuals.
With the ability to run on the fully automated cobas 6800 and cobas 8800 Systems, the test also has a full-process negative control, positive control and internal control.
