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Cepheid GeneXpert 4

Standardized CLIA Waived Molecular Testing

For physician offices and specialty clinics

Xpert® Xpress SARS-CoV-2*
Xpert® Xpress SARS-CoV-2/Flu/RSV plus*
Xpert® Xpress Strep A
Cepheid GeneXpert
Scalable Design: 2 and 4-module options available for customized throughput needs
Random Access: True, on-demand walkaway testing system
Easy Integration: No specialized training or daily maintenance required

Improved Diagnostics

Fast and accurate PCR results for your patients

RT-PCR Tests have >90% sensitivity compared to Rapid Influenza Diagnostic Tests (RIDTs) at 50-70%1
PCR can detect infection beyond 72 hours of illness onset2
PCR provides better detection of Flu & COVID-19 mutations positively impacting your clinical decisions
PCR improves treatment accuracy and antimicrobial stewardship

Download

PDF File
PDF
Read how a high-volume clinic reduced unnecessary treatment and improved provider confidence during a busy flu season
PDF File
PDF
Read a whitepaper by Frost & Sullivan on how to choose an effective COVID-19 diagnostic for your practice.

Simplified Workflow

Fits into existing point-of-care workflows

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GeneXpert Workflow:

• Prep and load samples in less than 1 minute

• True walk away workflow

• As easy as 1, 2, 3

1
Obtain swab speciman
swab speciman image
2
Transfer sample to cartridge 
workflow image
3
Insert cartridge and start test 
cepheid genexpert image

Watch: How the GeneXpert® Xpress System Can Improve Your Workflow

Targeted Test Menu

CLIA Waived tests for actionable, rapid respiratory results

Xpert

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

Positive Percent Agreement
Negative Percent Agreement
Flu A
Flu B
RSV
SARS-CoV-2
100%
100%
100%
100%
100%
100%
100%
100%
Xpert® Xpress Strep A image

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

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