Roche announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the cobas SARS-CoV-2 Qualitative PCR test for use on the fully automated cobas 6800 and cobas 8800 Systems.
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This standalone test is intended for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19 disease, in nasal and nasopharyngeal samples from symptomatic patients who are suspected of having COVID-19 as determined by their healthcare provider.
The cobas SARS-CoV-2 Qualitative test has been available in the U.S. under Emergency Use Authorization (EUA) since March 2020 and was the first commercial molecular test to receive this status.
The FDA clearance is based on a comprehensive package submitted to the agency, including analytical and clinical studies.
The cobas SARS-CoV-2 Qualitative assay is a single-well dual target assay, which includes both specific detection of SARS-CoV-2 and pan-sarbecovirus detection for the sarbecovirus subgenus that includes SARS-CoV-2.
The test is a real-time RT-PCR test intended for the qualitative detection of nucleic acids from SARS-CoV-2 in nasal and nasopharyngeal swab specimens collected from symptomatic individuals suspected of COVID-19 by their healthcare provider.
The test runs on the cobas 6800/8800 Systems and has a full-process negative control, positive control and internal control.
Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Results are meant to be used in conjunction with clinical observations, patient history, recent exposures and epidemiological information, and laboratory data, in accordance with the guidelines provided by the relevant public health authorities.
The cobas SARS-CoV-2 Qualitative assay is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and on the use of the cobas 6800/8800 Systems.
The Roche cobas 6800/8800 Systems, which are used to perform the cobas SARS-CoV-2 test, provide results in three and half hours and offer improved operating efficiency, flexibility, and fastest time-to-results with the highest throughput providing up to 96 results in about three hours and a total of 1,440 results for the cobas 6800 System and 4,128 results for the cobas 8800 System in 24 hours.
The test can be run simultaneously with other assays provided by Roche for use on the cobas 6800/8800 Systems. ■