Xpert® Xpress SARS-CoV-2

Cepheid has developed an automated molecular test for the qualitative detection of SARS-CoV-2.The test leverages the design principles of Xpert® Xpress Flu/RSV cartridge technology, in which multiple regions of the viral genome are targeted. The test can provide detection of coronavirus SARS-CoV-2 in approximately 45 minutes with less than a minute of hands on time to prepare the sample. The Xpert Xpress SARS-CoV-2 kit contains sufficient reagents to process 10 specimens or quality control samples. For use with GeneXpert II, IV, XVI, Infinity 48, Infinity 80, and Xpress Systems. The GeneXpert Instrument Systems automate and integrate sample preparation, nucleic acid extraction and amplification, and detection of the target sequences in simple or complex samples using real-time PCR assays. *For Use Under an Emergency Use Authorization (EUA) Only. Test pending submission and review by international regulatory agencies. The Emergency Use Authorization (EUA) authority under section 564 allows FDA to facilitate availability and unapproved uses of medical countermeasures needed to prepare for and respond to Chemical, Biological, Radiological, or Nuclear emergencies.

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Availability: Commercially Available

Paul Boschee
Director of Corporate Accounts
paul.boschee@cepheid.com
+1 408 400 4809
904 Caribbean Drive Sunnyvale, CA 94089
USA
Use the green "Request Info" button on the Cepheid website for region specific inquiries.
www.cepheid.com
Manufacturer
Cepheid
Product Name
Xpert® Xpress SARS-CoV-2
Detection Category
Biological
Detection Principle
Molecular;
Detection Method
Polymerase Chain Reaction;
Application
Detection;Diagnostics;
Product Model Number
XPRSARS-COV2-10
Equipment Type
Diagnostic
Product Synopsis
Cepheid has developed an automated molecular test for the qualitative detection of SARS-CoV-2.The test leverages the design principles of Xpert® Xpress Flu/RSV cartridge technology, in which multiple regions of the viral genome are targeted. The test can provide detection of coronavirus SARS-CoV-2 in approximately 45 minutes with less than a minute of hands on time to prepare the sample. The Xpert Xpress SARS-CoV-2 kit contains sufficient reagents to process 10 specimens or quality control samples. For use with GeneXpert II, IV, XVI, Infinity 48, Infinity 80, and Xpress Systems. The GeneXpert Instrument Systems automate and integrate sample preparation, nucleic acid extraction and amplification, and detection of the target sequences in simple or complex samples using real-time PCR assays. *For Use Under an Emergency Use Authorization (EUA) Only. Test pending submission and review by international regulatory agencies. The Emergency Use Authorization (EUA) authority under section 564 allows FDA to facilitate availability and unapproved uses of medical countermeasures needed to prepare for and respond to Chemical, Biological, Radiological, or Nuclear emergencies.
Availability
Commercially Available
Technology Readiness Level (TRL)
8
Market Entry Date
Spring 2020
User Feedback Sources
Indifferent/No user feedback
Weight
<30 lbs.
Power Requirements
None
Noise Produced
Negligible
Transportability
Pocket Size
Ruggedness
None
Operating Conditions
Store the Xpert Xpress SARS-CoV-2 cartridges at 2-28°C. Do not shake the cartridge. Shaking or dropping the cartridge after opening the cartridge lid may yield non-determinate results.
Solvents/Reagents
A viral transport tube containing 3 mL transport medium or 3 mL of saline.
Calibration Schedule
A Sample Processing Control (SPC) and a Probe Check Control (PCC) are also included in the cartridge.
Expected Operational Life
Each catridge is a single use item.
Other Biological Targets
SARS-CoV-2 (COVID-19)
Adaptability
No; cannot detect or add new targets
Sample Introduction
Liquid; Biological sample
Response Time (Sample Application To Output)
>15 minutes; <1 hour
Total Run Time
45 minutes
Other Operational Parameters
Appropriate sample types for testing include nasopharyngeal swabs (NPS) in UTM/VTM, nasal aspirates, and nasal washes. The specimen is collected and placed into a viral transport tube, mixed by inversion, and transferred to the sample chamber of the cartridge. The cartridge is loaded onto the GeneXpert Instrument System platform.
Training Required
<1 day training
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