VIDEO
Cepheid Receives Emergency Use Authorization for SARS-CoV-2, Flu A, Flu B and RSV Combination Test
Challenged by Similar Clinical Presentations, Accurate Detection & Differentiation of all 4 Viruses is Critical for Clinicians This Flu Season
Xpert® Xpress SARS-CoV-2/Flu/RSV
Actionable rapid respiratory results to meet the challenges of the ongoing pandemic
The Need
- Detection and differentiation of flu, RSV, and COVID-19 which all present with similar symptoms
- Insights for effective triage and patient management
- Risk assessment for patients and staff while resuming traditional healthcare procedures
- Identify potential cases of co-infections during respiratory season
- Current flu and SARS-CoV-2 therapies need definitive diagnosis for each pathogen
The Solution
- Actionable detection of SARS-CoV-2, Flu A, Flu B, and RSV in as little as 25 minutes^
- Actionable on-demand results with 1 sample collection
- Optimizes GeneXpert® System module capacity by combining 2 Xpress tests into 1
- Standardization of results between the central lab and near patient testing sites
The Impact
- Empower patients with rapid results to help keep their loved ones and the community safe
- Assist hospitals to effectively manage limited resources
- Provide labs with single-test confidence to accelerate workflows
- Support clinicians with on-demand, timely, and accurate results
*For Use Under an Emergency Use Authorization (EAU) only. This test has not been FDA cleared or approved; this test has been authorized by FDA under an EUA for use by authorized laboratories; this test has been authorized only for the simultaneous qualitative detection and differentiation of nucleic acids from SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV), and not for any other viruses or pathogens; and this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
^ For positives when running SARS-CoV-2 only on Xpress SARS-CoV-2/Flu/RSV; otherwise, the test will have a runtime of approximately 36 minutes.
