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Frequently Asked Questions
The US-IVD product and the EUA Xpert Xpress CoV-2 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 (version 1) test, there are several enhancements with the Xpert® Xpress CoV-2 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).
- Faster Turn-Around-Time, from approx. 45 min to approx. 30 min.
No. The US-IVD product does not yet have a CLIA Waived version. The Emergency Use Authorization includes use in CLIA Waived settings, and thus the EUA version of the Xpert Xpress CoV-2 plus can be used at the Point of Care (POC). For use in CLIA Waived settings separate from EUA, Cepheid is submitting for a CLIA Waiver. Once the 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 individuals suspected of COVID-19.
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 plus, US-IVD test.
The listed external controls are Zeptometrix External Controls:
- SARS Associated Coronavirus 2 (SARS-CoV-2) Positive Control, Catalog# NATSARS(COV2)-ERC
- SARS Associated Coronavirus 2 (SARS-CoV-2) Negative Control, Catalog# NATSARS(COV2)-NEG
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.
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 plus, US-IVD 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 plus, US-IVD). For customers who would like to order additional copies, please fill out the CD ADF request form on the Cepheid website.