CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
March 13, 2020—The FDA has issued an emergency use authorization for the Roche Cobas SARS-CoV-2. The single-well dual target assay includes specific detection of SARS-CoV-2 and pan-sarbecovirus detection for the sarbecovirus subgenus family that includes SARS-CoV-2. It 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 CDC 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.
“Providing quality, high-volume testing capabilities will allow us to respond effectively to what the World Health Organization has characterized as a pandemic. It is important to quickly and reliably detect whether a patient is infected with SARS-CoV-2,” Thomas Schinecker, CEO of Roche Diagnostics, said in a press release. “Over the last weeks, our emergency response teams have been working hard to bring this test to the patients. CE-mark certification and the FDA’s granting of EUA supports our commitment to give more patients access to reliable diagnostics which are crucial to combat this serious disease.”