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Average User Rating:

Cepheid - GeneXpert System
Contact:

Cepheid

904 Caribbean Drive

Sunnyvale, CA 94089

POC: Chinmay Sheth
System Cost: $79,200
Analysis Cost: $50
Survey Source: Vendor Supplied Information
General Description
The GeneXpert System is a closed, self-contained, fully-integrated and automated platform that represents a paradigm shift in the automation of molecular analysis, producing accurate results in a timely manner with minimal risk of contamination. The GeneXpert System is the only system to combine on-board sample preparation with real-time PCR (polymerase chain reaction) amplification and detection functions for fully integrated and automated nucleic acid analysis. The system is designed to purify, concentrate, detect and identify targeted nucleic acid sequences thereby delivering answers directly from unprocessed samples. Modular in design, the GeneXpert System has a variety of configurations to meet the broad range of testing demands of any clinical environment. The Cepheid GeneXpert System makes biothreat agent detection possible in minutes — all from unprepared samples. This easy-to-use, automated and highly accurate real-time PCR instrument combines the ingenuity of more than 30 patents into a sophisticated genetic tool for first responders. A patented, disposable, cartridge test for anthrax is available now, and can be performed on-site — delivering critical answers in critical situations.
Technical Description
The GeneXpert System fully integrates and automates the three processes required for real-time PCR-based molecular testing: sample preparation, amplification, and detection, all in one cartridge. On-demand. Just load a biological sample and the system does the rest.
Notes:
In use by U.S. Postal screening systems
Evaluation Criteria
THROUGHPUT:
  • Between 60 minutes and 8 hours for detection
  • 1 sample, <10 tests/sample per run
  • 349-96 samples every 2 hours
  • The system or device is currently fully automated
  • Device or system is intended for multiple detection assays
  • 2 solutions, buffer, eluents, and/or reagents
  • 1 component
  • No set-up of the system is required
  • 1-2 steps are required for detection
LOGISTICS:
  • Very brief (minutes-hours) training and minimal technical skills
  • Between 5 and 25 kg
  • Wired connections are available
  • System or device has 110V electrical requirement
OPERATIONS:
  • Can be used from 4°C to 41°C
  • Components must be stored at room temperature (27°C)
  • Performance is not influenced by relative humidity
  • Between 6 months and 1 year shelf life
  • Greater than 10 years expected life
  • Results can be viewed in real-time
  • The system is not capable of autonomy
  • The system software is closed and not available for modification
  • The system hardware is closed and not available for modification
DETECTION:
  • System currently has 510k clearance
  • System currently has FDA approval
  • Less than 250 µL
  • Excellent specificity. System has occasional false alarms
  • under certain conditions (<2%)
  • Fully automated spore lysis
Tier Selection
BioImageChemImageRadImage
Field Use
Mobile
Diagnostic
Analytical
Tier Key:
Tier 1 Top Tier
Tier 2 Second Tier
Tier 3 Third Tier
Tier 4 Fourth Tier
Tier 5 Bottom Tier
Scoring Analysis
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Impact Chart
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FIELD USE
MOBILE USE
DIAGNOSTIC USE
ANALYTIC USE