Xpert® Xpress CoV-2 plus

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

The specimen is collected and placed into a viral transport tube containing 3 mL viral transport medium (VTM)/Universal Transport Medium (UTM) or 2 mL eNAT™.

Refer to package insert for details.

The listed external controls are Zeptometrix External Controls:

• SARS Associated Coronavirus 2 (SARS-CoV-2) Positive Control, Catalog# NATSARS(COV2)-ERC-IVD
  
  
• SARS Associated Coronavirus 2 (SARS-CoV-2) Negative Control, Catalog# NATSARS(COV2)-NEG-IVD
   

These are described in the “materials available but not provided” section of the package insert.

Yes. The FDA cleared product is also CLIA Waived for use on GeneXpert® Xpress systems. Refer to 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 plus, are available for download here. A CD containing the ADF is also being provided with the first order of XPRS-COV2-10 or on their first order post ADF update for existing XPRS-COV2-10 users. For customers who would like to order additional copies, please fill out the CD ADF request form on the Cepheid website. USA CD ADF REQUEST FORM

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 the 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 two versions of the tests, there are some differences in the product claims compared to the EUA version:

• Populations
  Populations are no longer supported or claimed for the FDA cleared version: asymptomatic and those suspected of COVID-19 disease
  
  
• Sample types
  The following sample types are no longer supported for the FDA cleared version: nasal aspirate/wash, mid-turbinate, and oropharyngeal. Nasopharyngeal and Anterior Nasal are still on-label.
  
  
• Collection media
  The following collection media is no longer supported for the FDA cleared version: saline.
  
  
• Sample storage conditions
  Now ON-LABEL for 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.