Xpert® Xpress CoV-2/Flu/RSV plus

Sample Types: Nasopharyngeal swab and anterior nasal swab specimens collected from individuals with signs and symptoms of respiratory tract infection.

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.

Yes. The FDA cleared product is for moderate complexity environment and CLIA waived for use on GeneXpert® Xpress systems. Refer to the applicable package insert for details.

Before going live with a new test, a verification study may be necessary. Please refer to your relevant laboratory accreditation regulations for verification requirements. 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. The decision to perform verification studies and the level of verification required is at the discretion of the laboratory director and should be conducted according to applicable regulations.

In an effort to reduce waste, 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 with the first order place of XPRS4PLEX-10 or on the first order post ADF update for existing XPRS4PLEX-10 users. For customers who would like to order additional copies and/or misplaced the CD, please fill out the CD ADF request using the following link: USA CD ADF REQUEST FORM

The FDA cleared and the EUA Xpert Xpress CoV-2/Flu/RSV plus products are technologically identical. There are no changes to the chemistry sample processing, consumables, procedures 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.

Both product versions cannot be used interchangeably, each has its unique catalog number, labels, and ADFs. Customers are recommended to utilize (finish) their existing inventory of EUA product before transitioning to the FDA cleared version of product.

Yes. For GeneXpert systems that are compatible with both the EUA and FDA cleared products, the ADFs can be installed and used concurrently for both versions of product, on the same computer. Please Note: The EUA version is not compatible with GeneXpert System with Touchscreen.

While there are no significant performance differences between both versions of the tests, there are some differences in the product claims compared to the EUA version:

• Sample types
  The following sample types are no longer supported by the FDA cleared version: nasal aspirate/wash. Nasopharyngeal and Anterior Nasal swabs are still on-label.
  
  
• Collection media
  The following collection media is no longer supported by the FDA cleared version: saline.
  
  
• Sample storage conditions
  Now ON-LABEL on the FDA cleared version: Frozen (-80ºC) NPS and NS specimens in VTM/UTM and eNAT that have undergone 1 freeze/thaw cycle are now on claim.
   

See IFU for details.