Standardized CLIA Waived Molecular Testing
For physician offices 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
CPT Code: 87635
Xpert® Xpress SARS-CoV-2*
Positive results in as soon as 30 minutes^
Sample Type: Nasopharyngeal or nasal swabs
Positive Percent Agreement
97.8%
Negative Percent Agreement
95.6%
PLA Code: 02420U or 0241U
Xpert® Xpress SARS-CoV-2/Flu/RSV plus*
Positive results in as soon as 25 minutes#
Sample Type: Nasopharyngeal or nasal swabs
CPT Code: 87651
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
* For use under an Emergency Use Authorization in the United States.
^ With early assay termination for positive results; negatives reported in approximately 45 minutes.
# For positives when running SARS-CoV-2 only on Xpress SARS-CoV-2/Flu/RSV; otherwise, the test will have a runtime of approximately 36 minutes.
† With early assay termination for positive results; negatives reported in approximately 24 minutes.
Refer to Package Insert Xpert Xpress Strep A 301-6574 Rev D, Package Insert Xpert Xpress Strep A CW 302-2294 Rev. A and 301-6127 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
