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Xpert® HCV Viral Load

Xpert® HCV Viral Load

Product catalog summary

Introduction
Xpert® HCV Viral Load is an in vitro diagnostic medical device designed to provide ultrasensitive results for effective treatment of Hepatitis C Virus (HCV). It addresses the need for a simple, flexible, and highly sensitive viral load test to support new drug regimens.

The Need
Globally, approximately 185 million people are infected with HCV, leading to 350,000 to 500,000 deaths annually from related liver diseases. The primary goal of HCV treatment is achieving a Sustained Virologic Response (SVR), which is the absence of detectable HCV RNA 12 or 24 weeks post-treatment. Current tests are complex and require skilled technicians, highlighting the need for a more user-friendly solution.

The Solution
Xpert HCV Viral Load offers on-demand molecular testing using GeneXpert technology. It employs automated RT-PCR with fluorescence to detect and quantify HCV RNA, covering genotypes 1-6 over a range of 10 to 100,000,000 IU/mL. Key features include:

Ultrasensitivity: LOD of 4.0 IU/mL in EDTA plasma and 6.1 IU/mL in serum.
Ease of Use: Less than 1 minute hands-on time, no PCR room requirements, and no daily maintenance.
Flexibility: 105-minute run time, compatible with any lab volume, and up to 345 results per 8-hour shift.

Performance
A multi-site study compared Xpert HCV Viral Load with a comparator method using 607 specimens. The test demonstrated high sensitivity and reliability, with a maximum LOD of 4.0 IU/mL in plasma and 6.1 IU/mL in serum.

Impact
The test improves patient care by providing same-day results, increases efficiency with sensitive viral load measurements, and strengthens community health by enabling quick treatment decisions. It supports flexible lab operations with 24/7 random access and the ability to run multiple tests simultaneously.

Conclusion
Xpert® HCV Viral Load is a significant advancement in HCV management, offering rapid, reliable, and easy-to-use testing that enhances patient care and laboratory efficiency.

Catalog excerpts

Xpert HCV Viral Load ® Xpert HCV Viral Load ® Ultrasensitve Results for Effective Treatment In Vitro Diagnostic Medical Device

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Cepheid’s Xpert® HCV Viral Load test delivers results in hours rather than days — with the simplicity and ease of use of a point-of-care test. It is a very sensitive test for confirmation of infection and monitoring of HCV, and will assist in better patient management.” Pr. Jean-Michel Pawlotsky M.D., Ph.D. Professor of Medicine at the University of Paris-Est Director of the National Reference Center for Viral Hepatitis B, C and Delta Director of the Department of Virology at the Henri Mondor University Hospital in Créteil, France Director of the Department of Molecular Virology and Immunology...

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THE IMPACT • Improve Patient Care: Same day results support better clinical decisions • Increase Efficiency: Highly sensitive quantitative viral loads of HCV enable earlier adjustments to therapy • Strengthen Communities: Quick decisions can help reduce transmission Move your lab forward • No Waiting: Deliver individual patient results when they’re most needed • Simple & Organised: True 24/7 random access accommodates other urgent test requests • Flexible: Adapt to any throughput requirement • Improve Service: Run more than one test simultaneously PERFORMANCE A multi-site study was conducted...

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Total hands-on time: <1 minute System Throughput* 8-hr shift Transfer at least 1 mL of plasma or serum into the cartridge * Operational throughput per 8-hr shift based on HCV Viral Load testing, internal analysis. Scan, load cartridge and start test Xpert® HCV Viral Load provides reliable, on-demand results in less than 2 hours. CATALOG INFORMATION Xpert HCV Viral Load Mohd Hanafiah K, et al. Global epidemiology of hepatitis C virus infection: new estimates of age-specific antibody to HCV seroprevalence. Hepatology 2013; 57(4): 1333-42. WHO. Hepatitis C Fact Sheet N° 164. Updated April 2014....

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.

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