Standardized CLIA Waived Molecular Testing
For physician offices, urgent cares and specialty clinics
Improved Diagnostics
Fast and accurate PCR results for your patients
Simplified Workflow
Fits into existing point-of-care workflows
GeneXpert Workflow:
• Prep and load samples in less than 1 minute
• True walk away workflow
• As easy as 1, 2, 3
Watch: How the GeneXpert® Xpress System Can Improve Your Workflow
Targeted Test Menu
CLIA Waived tests for actionable, rapid respiratory results
Xpert® Xpress CoV-2 plus*
Positive results in as soon as 20 minutes^
Sample Type: Nasopharyngeal, Anterior nasal swabs, Oropharyngeal,# Mid-turbinate swab, Nasal wash/aspirate#
Xpert® Xpress CoV-2/Flu/RSV plus*
Positive results in as soon as 25 minutes†
Sample Type: Nasopharyngeal, anterior nasal swabs, or nasal wash/aspirates‡
Xpert® Xpress Strep A
Positive results in as soon as 18 minutes§
Sample Type: Throat swab
Sensitivity
Specificity
Positive Predictive Value
Negative Predictive Value
CLIA-Waived
99.4%
94.1%
85.3%
99.8%
Watch: How a Cepheid Molecular Test is Developed
- Xpert Xpress Strep A
- Xpert Xpress Strep SARS-CoV-2
- Xpert Xpress Strep SARS-CoV-2/Flu/RSV
References
*These tests have not been FDA cleared or approved. These tests have been authorized by FDA under an EUA for use by authorized laboratories. Xpert Xpress CoV-2 plus has been authorized only for the detection of nucleic acids from SARS-CoV-2, and not for any other viruses or pathogens. Xpert Xpress CoV-2/Flu/RSV plus 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. The emergency use of these products is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
**PPA and NPA for asymptomatic specimens were calculated using anterior nasal swab specimens.
^ With early assay termination for positive results; otherwise, the full test runtime is approximately 30 minutes.
#Specimen type not supported for use with GeneXpert Xpress systems (point of care)
† Approximately 36 minutes. When running SARS-CoV-2 only, positive results in as soon as 25 minutes
‡ See package insert for details, sample types vary by system. Nasal wash/aspirate samples not available for use with GeneXpert Xpress systems (Tablet and Hub Configurations)
§ With early assay termination for positive results; negatives reported in approximately 24 minutes. Refer to Package Insert Xpert Xpress Strep A 301F6574 Rev D, Package Insert Xpert Xpress Strep A CW 302F2294 Rev. A and 301F6127 Quick Ref Guide, Xpress Strep A
1. https://www.cdc.gov/flu/professionals/diagnosis/clinician_guidance_ridt.htm
2. https://www.cdc.gov/flu/professionals/diagnosis/algorithm-results-circulating.htm
