Cepheid Xpert C. difficile

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Product Details:

Usage Type Laboratory
Function C. difficile toxin gene (tcdB) detection
Features On-demand, single sample testing; closed system; minimal hands-on time
Storage Instructions Store at 228C, do not freeze
Measurement Range Qualitative detection
Shelf Life Usually 12 months from manufacture
Instruments Type Diagnostic Cartridge
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Cepheid Xpert C. difficile Price And Quantity

Cepheid Xpert C. difficile Product Specifications

Weight Cartridge: ~60 g
Real-Time Operation Yes
Usage Type Laboratory
Technology Real-Time PCR
Instruments Type Diagnostic Cartridge
Operating Type Automated
Power Source Not Applicable (analyte cartridge; require GeneXpert instrument)
Function C. difficile toxin gene (tcdB) detection
Dimension (L*W*H) Cartridge size: Approximately 12 cm x 5 cm x 4 cm
Shelf Life Usually 12 months from manufacture
Condition New
Measurement Range Qualitative detection
Storage Instructions Store at 228C, do not freeze
Features On-demand, single sample testing; closed system; minimal hands-on time
Accuracy >95% (based on clinical sensitivity/specificity)
Wall Mounted No
Color Transparent/White cartridge
Material Plastic/Polymer Cartridge
Use Detection of Clostridium difficile toxin genes
Equipment Type Molecular Diagnostic Assay
Portable No (for use with GeneXpert System only)

Intended Users Trained Laboratory Professionals
Sample Volume Approximately 300 µL
Controls Included Probe Check Control, Sample Processing Control, and Internal Control
CE-IVD Marked Yes
Compatibility For use with Cepheid GeneXpert Systems Only
Analysis Time ~45 minutes per test
Target Genes tcdB (toxin B), cdt (binary toxin), tcdC (deletion)
Regulatory Status CE-IVD, FDA Cleared
Sample Type Unformed stool

Cepheid Xpert C. difficile Trade Information

Supply Ability 100 Unit Per Week
Delivery Time 7 Days

Product Description

Brand	Cepheid
Product Type	PCR Kit
Pack Size	10T
CAT No	GXCDIFFICILE-10
Application	Molecular Biology

Cepheid's Xpert C. difficile test provides on-demand results you can trust and empowers your clinical team to better manage patients. Cepheid's XpertA C. difficile delivers both in just 40 minutes:

Superior test accuracy eliminates the need for additional or repeat testing
Testing of all suspected CDI cases directly with PCR is cost effective
Rapid identification of infected patient helps infection control efforts
Timely reporting enables clinicians to administer appropriate therapy thereby improving patient management.

Rapid and Reliable C. difficile Detection

The Cepheid Xpert C. difficile test enables laboratories to rapidly identify toxin-producing Clostridium difficile using real-time PCR technology. Its straightforward cartridge system streamlines workflows, delivering results in less than an hour. By automating sample processing and analysis, this assay reduces human error and enhances laboratory productivity, providing high confidence in clinical diagnostics.

Fully Automated and Easy-to-Use Cartridge System

This molecular assay incorporates a closed, single-use plastic/polymer cartridge that houses all necessary reagents and controls. The process requires only approximately 300 L of unformed stool, with minimal hands-on steps. All sample processing, amplification, and detection take place within the cartridge, ensuring safety and efficiency. The system is exclusively designed for use with Cepheid GeneXpert instruments.

Designed for Clinical Laboratory Environments

CE-IVD and FDA clearances confirm the Xpert C. difficile's suitability for regulated laboratory settings. The cartridge's robust design supports ambient storage (2-28C) and simplifies inventory. With a shelf life of up to 12 months and on-demand testing capability, it caters to busy clinical laboratories as a dependable, high-throughput diagnostic option.

FAQ's of Cepheid Xpert C. difficile:

Q: How does the Cepheid Xpert C. difficile assay detect Clostridium difficile toxins?

A: The assay employs real-time PCR technology to qualitatively detect key C. difficile toxin genes (tcdB, cdt, tcdC deletions) directly from unformed stool. The cartridge contains all necessary reagents and controls to ensure precise and reliable results.

Q: What is the recommended sample type and volume for this test?

A: The test is validated for use with unformed stool specimens, requiring approximately 300 L. Only this sample type should be used to ensure accuracy and validity of the test results.

Q: When can I expect results after beginning the assay?

A: The Xpert C. difficile provides results in roughly 45 minutes per test, significantly expediting clinical decision-making and infection control procedures.

Q: Where can this product be used and who is authorized to operate it?

A: This diagnostic assay is intended for use in licensed clinical laboratories by trained laboratory professionals. It is not meant for home or point-of-care use and requires the Cepheid GeneXpert System for operation.

Q: What controls are incorporated to ensure test reliability?

A: Each cartridge includes a Probe Check Control, Sample Processing Control, and Internal Control. These built-in controls monitor for proper reagent performance, sample processing, and the overall validity of each assay run.

Q: What are the primary benefits of using the Xpert C. difficile assay in the laboratory?

A: Key advantages include rapid, highly accurate detection (>95% accuracy), a fully automated workflow, minimal sample handling, on-demand single-sample testing, and reduced risk of contamination thanks to the closed cartridge system.

Q: How should cartridges be stored and what is the shelf life?

A: Cartridges should be kept at 2-28C and must not be frozen. Shelf life is typically 12 months from the date of manufacture, allowing for convenient and flexible inventory management.

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