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Xpert® Xpress CoV-2/Flu/RSV plus (US-IVD Moderately Complex)
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Copan 3C057N (Nasopharyngeal Swab) (Pack of 50)
3C057N
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Copan 3C064N (Nasal Swab) (Pack of 50)
3C064N
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Frequently Asked Questions
The 510(k) cleared product and the EUA Xpert Xpress CoV-2/Flu/RSV plus products are technologically the same; that is, there are no changes to the chemistry or analysis settings of the tests. They do, however, have different Catalog Numbers, unique ADFs, and differ in intended use. Please see respective IFUs for intended use differences.
When compared to the Xpert Xpress SARS-CoV-2/Flu/RSV (version 1) test, there are several enhancements with the Xpert® Xpress CoV-2/Flu/RSV plus (version 2) test. Key enhancements include:
- The addition of a 3rd gene target for SARS-CoV-2 (RdRp now included in addition to E and N2), to be more robust against mutations.
- Expansion of on-label transport media options to include the addition of eNAT® (Copan).
No. The 510(k) product does not yet have a CLIA Waived version. The EUA version of the Xpert Xpress CoV-2/Flu/RSV plus product is included for use at Point of Care (POC) and can be used in CLIA Waived settings. Cepheid is submitting for CLIA Waived status 510(k) version and expects that process to be completed by Q3 2024. Until CLIA Waiver is obtained, the EUA and US-IVD versions of the product will both remain in the market to be used in POC settings and Moderate Complexity settings, respectively.
Though the cartridge design and contents are the same, the EUA and US-IVD versions of the product are different; each has its unique catalog number, labels, and ADFs. Thus, they cannot be used interchangeably. GeneXpert® Dx and Infinity customers should utilize (finish) their existing inventory of EUA products before transitioning to the US-IVD version of the product.
GeneXpert Dx and Infinity Systems:
Sample Types:
- Nasopharyngeal swabs and anterior nasal swabs collected from individuals with signs and symptoms of respiratory tract infection.
Collection Devices:
Nylon flocked swabs, viral transport medium (VTM), Universal Transport Medium (UTM) and eNAT® Molecular Transport Medium are compatible for use with the Xpert Xpress CoV-2/Flu/RSV plus, US-IVD test.
The listed external controls are Zeptometrix External Controls:
- External Positive Control – NATtrol Flu/RSV/SARS-CoV-2; Cat # NATFRC-6C-IVD
- External Negative Control – Coxsackievirus A9; Cat # NATCV9-6C-IVD
These are described in the "materials available but not provided" section of the package insert.
Before going live with a new test, a verification study may be necessary. Please follow your laboratory and regulatory requirements when instituting a new test in your laboratory. A verification guide that describes the preparation of contrived positive specimens (prepared by spiking commercial reference material into negative specimens) is available for download on the Cepheid website: Verification Guide.
For GeneXpert Dx and Infinity customers transitioning from EUA to US-IVD, please contact your FAS representative for additional support
In an effort to reduce our environmental footprint, Cepheid will provide electronic copies of Instructions for Use (IFU) and Assay Definition Files (ADF). The IFUs, ADFs, and ADF import instructions for Xpert® Xpress CoV-2/Flu/RSV plus are available for download here. A CD containing the ADF is also being provided to customers on their first order of this product (Xpert Xpress CoV-2/Flu/RSV plus, US-IVD). For customers who would like to order additional copies, please fill out the CD ADF request using the following link: