DOCUMENT
eNAT IFU
Copan eNAT® Molecular Collection and Preservation Medium
Xpert® Xpress CoV-2/Flu/RSV plus
Actionable, rapid respiratory results to meet the challenges of the ongoing pandemic.
The Need
- Rapidly detect SARS-CoV-2, including emerging variants, to provide timely, effective triage.
- Accurately diagnose respiratory tract infections to ensure appropriate treatment.
- Rapidly differentiate flu, RSV, and SARS-CoV-2 and potential co-infections during respiratory season.
The Solution
- Robust design with three distinct gene targets for SARS-CoV-2: N2, E, RdRP.
- Accurate detection and differentiation of SARS-CoV-2, Flu A, Flu B, and RSV. Results for SARS-CoV-2 in as little as 25 minutes.^
- Actionable results from a single sample with less than one minute of hands-on time.
- Standardization of results between the central lab and near-patient testing sites.
The Impact
- 3-gene design supports clinicians with broader coverage for SARS-CoV-2 variants.
- Ensures that patients receive appropriate treatment in a timely manner.
- Single cartridge with an easy-to-use workflow, enabling effective management of limited resources.
For Use Under an Emergency Use Authorization (EUA) 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.
Full test runtime is 36 minutes. SARS-CoV-2 positive results available in as soon as 25 minutes with early assay termination.
Ordering Info
Xpert® Xpress CoV-2/Flu/RSV plus
Number of Tests: 10
Catalog #: XP3COV2/FLU/RSV-10