13th March 2020 Product update: Roche Diagnostics
Roche cobas SARS-CoV-2 Test is Now CE-IVD and FDA-EUA Approved
Roche has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its cobas® SARS-CoV-2 Test. It is intended for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19 disease, in nasopharyngeal and oropharyngeal swab samples from patients who meet COVID-19 clinical and/or epidemiological criteria for testing.
Hospitals and reference laboratories can run the test on Roche's fully automated cobas® 6800 and cobas® 8800 Systems, which are widely available in the U.S. and around the world. The CE-IVD Test is also available in markets accepting the C.E. mark for patients with signs and symptoms of COVID-19 disease and living in affected areas where the SARS-CoV-2 virus is known to be present.
The widely available Roche's cobas 6800/8800 Systems, which are used to perform the cobas SARS-CoV-2 Test, provide test 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.
The cobas SARS-CoV-2 Test is a single-well dual-target assay, which includes both specific detection of SARS-CoV-2 and pan-sarbecovirus detection for the sarbecovirus subgenus family 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 nasopharyngeal and oropharyngeal swab samples from patients who meet the C.D.C. SARS-CoV-2 clinical criteria. 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. Negative results must be combined with clinical observations, patient history, and epidemiological information.
The cobas SARS-CoV-2 is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. In the United States, the cobas SARS-CoV-2 is only for use under the F.D.A.'s Emergency Use Authorization.
Date Published: 13th March 2020
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