Xpert HCV Viral Load

Xpert® HCV Viral Load

Ultrasensitve Results for Effective Treatment

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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 at the Institut Mondor de Recherche Biomédicale

    An estimated 185 million people, 3% of the world’s population, have been infected with HCV.1 Each year, 350,000 to 500,000 people die from HCV-related liver disease.2

    The primary objective of anti-HCV treatment is the Sustained Virologic Response (SVR), defined as undetectable HCV RNA by a sensitive test 12 or 24 weeks after the end of treatment.3 With increasing numbers of patients achieving SVR following treatment, eradication of HCV is being discussed for the first time.4

    Existing HCV viral load tests are complicated to use, require complex technical settings and highly trained technicians to operate.

    An ultrasensitive, easy to use HCV viral load test with the flexibility to adapt to any throughput is critical as a companion test for newly developed drug regimens.

    (1) 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. (2) WHO. Hepatitis C Fact Sheet N° 164. Updated April 2014. Accessed April 2015 at http://www.who.int/mediacentre/factsheets/fs164/en/; (3) Ghany MG, et al. Diagnosis, management, and treatment of hepatitis C: an update. Hepatology 2009 Apr;49 (4):1335-74. (4) Graham CS, et al. A Path to Eradication of Hepatitis C in Low-and-Middle-Income Countries. Antiviral Res. 2015 Jan 20; pii: S0166-3542(15)00005-4. [Epub ahead of print].

    Xpert HCV Viral Load is a quantitative test that provides on-demand molecular testing for diagnosis# and monitoring of HCV.
    Based on the GeneXpert technology, Xpert HCV Viral Load utilises automated reverse transcriptase polymerase chain reaction (RT-PCR) using fluorescence to detect and quantify RNA.

    Xpert HCV Viral Load quantifies HCV genotypes 1–6 over the range of 10 to 100,000,000 IU/mL.

    Redefining Simple:

    Ultrasensitive

    • LOD of 4.0 IU/mL in EDTA plasma (95% CI 2.8 – 5.2)
    • LOD of 6.1 IU/mL in serum (95% CI 4.2 – 7.9)

    Easy

    • 1 minute hands-on time
    • Run daily or on-demand
    • No requirements for PCR room settings
    • No daily maintenance or liquid waste management

    Flexible

    • 105 minutes run time with a viral load trend report*
    • Compatible with any lab volume
    • Providing up to 345 viral load results per 8 hours^
    • Random access 24/7 availability
    • Fixed cost per reportable result independent of daily volume

    *   Trend report available for patients’ viral load measured multiple times on the same GeneXpert.
    ^   Operational throughput on Infinity-80; internal analysis.
    #   Interpretation in conjunction with other clinical and laboratory findings

    • 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

     

     

    • Cepheid - The Molecular Diagnostics Leader
    • Catalog #: GXHCV-VL-CE-10

      Xpert HCV Viral Load
      Number of Tests: 10

    • How can I place an order?

      Submit your request using our Request Information form, or call 1.888.838.3222, select option 1.