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Cepheid GeneXpert 4

Standardized CLIA Waived Molecular Testing

For physician offices, urgent cares and specialty clinics

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

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

Obtain swab speciman
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Transfer sample to cartridge 
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Insert cartridge and start test 
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Watch: How the GeneXpert® Xpress System Can Improve Your Workflow

Targeted Test Menu

CLIA Waived tests for actionable, rapid respiratory results

  • Xpert Xpress Strep A
  • Xpert Xpress Strep SARS-CoV-2
  • Xpert Xpress Strep SARS-CoV-2/Flu/RSV


*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

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