Xpert® HCV Viral Load
Highly sensitive, timely results for effective patient management and improved access to testing.
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The Need

An estimated 185 million people, 3% of the world's population, have been infected with HCV.1 An estimated 399,000 people died from HCV in 2016.2
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
The need for a rapid HCV viral load test with flexibility to adapt to any throughput requirements and random access for urgent samples is greater than ever.
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. Accessed Jul 2021. https://www.who.int/en/news-room/fact-sheets/detail/hepatitis-c
(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.

The Solution

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
  • 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)^
  • Minimal hands-on time
  • Run daily or on-demand
  • No requirements for PCR room settings
  • No daily maintenance or liquid waste management
  • 105 minutes run time with a viral load trend report#
  • Provide timely results for 1 to 345 tests on demand
  • Random access 24/7 availability
  • Quantification standards run in every test for fixed cost per reportable result independent of daily volume
* Interpretation in conjunction with other clinical and laboratory findings.
^ HCV genotype 1 (WHO 4th International standard).
# Trend report available for patients'viral load measured multiple times on the same GeneXpert System.
† Operational throughput on Infinity-80; internal analysis..

(5)Xpert HCV Viral Load. Package Insert. 301-3019 Rev J February 2021

The Impact

  • Increase Efficiency: Simplified workflow and on demand testing reduces hands-on time
  • Improve Patient Care: Fast results enable earlier adjustment to appropriate therapy
  • Better for Patients: Same day results and treatment decisions reduces anxiety and time for multiple clinical appointments
Move Your Lab Forward
  • No Waiting: Run any test anytime with 24/7 random access
  • Flexible: Adaptable to meeting throughput requirements
  • Improve Sample Processing: Speed up results turnaround time to meeting clinical need and deliver a better service