Cepheid Xpert HBV Viral Load

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Product Details:

Instruments Type IVD Cartridge for GeneXpert System
Display Type NA (analyzed via GeneXpert instrument display)
Features Rapid results, Easy workflow, High sensitivity and specificity
Storage Instructions Store at 228C, protected from sunlight
Function Detection and quantification of HBV DNA
Usage Type Laboratory
Shelf Life Varies per manufacturer guidelines (usually 12-18 months)
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Cepheid Xpert HBV Viral Load Price And Quantity

Sample Type Human Plasma or Serum
Regulatory Status CE-IVD, FDA cleared (Region dependent)
Target Region HBV DNA
Assay Principle Automated Nucleic Acid Extraction and Real-Time PCR
Sample Volume 1 mL
Waste Disposal Biohazard regulations apply; single-use cartridge
Analytical Sensitivity 10 IU/mL
Intended User Healthcare Professionals, Clinical Laboratories
Package Content Disposable, ready-to-use cartridge with integrated reagents
Time to Result < 90 minutes
Compatible Instruments GeneXpert and GeneXpert Infinity Systems
Operator Training Minimal; user-friendly cartridge-based system
Lot Traceability Unique lot and barcode on each cartridge

Cepheid Xpert HBV Viral Load Product Specifications

Storage Instructions Store at 228C, protected from sunlight
Function Detection and quantification of HBV DNA
Usage Type Laboratory
Shelf Life Varies per manufacturer guidelines (usually 12-18 months)
Color Transparent/White (cartridge body)
Display Type NA (analyzed via GeneXpert instrument display)
Wall Mounted No
Features Rapid results, Easy workflow, High sensitivity and specificity
Accuracy High; Correlates with international reference standards
Use Quantification of Hepatitis B Virus (HBV) DNA
Weight Cartridge: Approx. 50 g
Measurement Range 10 IU/mL to 1x10^9 IU/mL
Noise Level Low
Technology Real-Time PCR (Polymerase Chain Reaction)
Portable No, requires compatible instrument
Dimension (L*W*H) Cartridge: Approx. 12 cm x 4 cm x 4 cm
Instruments Type IVD Cartridge for GeneXpert System
Operating Type Automatic
Condition New
Material Plastic & Reagents
Power Consumption As per analyzer configuration
Equipment Type Molecular Diagnostic Assay
Voltage As per analyzer requirements
Real-Time Operation Yes
Power Source Electrical (compatible with GeneXpert Instrument)

Sample Type Human Plasma or Serum
Regulatory Status CE-IVD, FDA cleared (Region dependent)
Target Region HBV DNA
Assay Principle Automated Nucleic Acid Extraction and Real-Time PCR
Sample Volume 1 mL
Waste Disposal Biohazard regulations apply; single-use cartridge
Analytical Sensitivity 10 IU/mL
Intended User Healthcare Professionals, Clinical Laboratories
Package Content Disposable, ready-to-use cartridge with integrated reagents
Time to Result < 90 minutes
Compatible Instruments GeneXpert and GeneXpert Infinity Systems
Operator Training Minimal; user-friendly cartridge-based system
Lot Traceability Unique lot and barcode on each cartridge

Cepheid Xpert HBV Viral Load 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	GXHBV-VL-CE-10
Application	Molecular Biology

Xpert HBV Viral Load on the GeneXpert System

Accurate and reliable quantification of HBV DNA in human serum or plasma
Flexible throughput for any testing setting with round the clock, on-demand results
Simplify disease management with the possibility of having sample to viral load results less than one hour.

Streamlined Viral Load Testing for HBV

Cepheid Xpert HBV Viral Load offers an all-in-one system for fast, reliable quantification of Hepatitis B Virus DNA. Its easy-to-use cartridge format integrates sample processing and analysis, reducing hands-on time and simplifying workflow for busy clinical laboratories and healthcare environments.

High Sensitivity and Rapid Turnaround

Delivering results in under 90 minutes, this assay boasts analytical sensitivity down to 10 IU/mL and a measurement range up to 1 109 IU/mL. Healthcare professionals can make prompt, informed decisions for patient management, thanks to real-time PCR technology and robust international-standard accuracy.

Safety, Compliance, and Traceability

Each disposable cartridge includes integrated reagents and features a unique lot number and barcode for complete traceability. The design meets biohazard waste regulations and supports shelf-life stability between 12 and 18 months when stored at 2-28C and away from sunlight.

FAQ's of Cepheid Xpert HBV Viral Load:

Q: How does the Cepheid Xpert HBV Viral Load assay work?

A: The assay uses an automated cartridge that extracts nucleic acids and performs real-time PCR to detect and quantify HBV DNA in human plasma or serum. The process takes less than 90 minutes, requiring only 1 mL of sample, and provides results on a GeneXpert instrument.

Q: What are the benefits of using this assay in clinical laboratories?

A: Benefits include rapid turnaround, high sensitivity down to 10 IU/mL, minimal operator training, standardized workflow, and a disposable cartridge for easy, biohazard-compliant waste disposal. Accuracy correlates with international reference standards, supporting reliable patient care.

Q: When should this assay be used?

A: This assay is intended for the quantification of HBV DNA to support diagnosis, treatment monitoring, and clinical management of patients with hepatitis B infection. Laboratories can use it whenever fast, precise viral load data is needed.

Q: Where can the Cepheid Xpert HBV Viral Load test be run?

A: The assay is designed for use in clinical laboratories and healthcare settings equipped with compatible GeneXpert or GeneXpert Infinity Systems. It is not portable or intended for point-of-care use, as it requires electrical power and designated analyzers.

Q: What process should be followed for waste disposal of used cartridges?

A: After testing, the single-use cartridge should be disposed of in accordance with local biohazard waste regulations. The design ensures safe handling and traceability through a unique lot barcode system.

Q: How should unused assay cartridges be stored?

A: Store the cartridges at 2-28C, protected from direct sunlight. Always follow manufacturer guidelines regarding shelf life (typically 12-18 months) to maintain reagent integrity and test performance.

Q: What are the sample requirements and compatible instruments for this assay?

A: The assay requires 1 mL of human plasma or serum and runs exclusively on GeneXpert or GeneXpert Infinity Systems, ensuring seamless integration into laboratory workflows.

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