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Respiratory Diagnostic Test Given Emergency Use Permission by FDA

12th June 2024

The cobas liat SARS-CoV-2, influenza A/B, and RSV nucleic acid test (Roche) have been approved for use in emergencies by the FDA. For the Cobas Liat system, the test is a programmed real-time polymerase chain reaction assay that takes around 20 minutes to complete.

 

Matt Sause, CEO of Roche Diagnostics, commented: “Diagnostics play a critical role in the fight against respiratory illness.”

He continued: “We are proud to provide this innovative test to address the significant burden placed on health care systems. Now, health care professionals will be able to detect and differentiate these respiratory viruses within a single patient visit, enabling improved public health outcomes.”

 

Only professionals with training in the Cobas Liat system may take the test, and only in accordance with the EUA.

 

Although positive findings suggest the presence of illnesses, they cannot rule out co-infection or an infection with bacteria. Furthermore, the news release states that negative findings do not rule out infection and that they should not be the only factor considered when making decisions.

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