Introduction
Xpert® HBV Viral Load is an in vitro diagnostic medical device designed to simplify the management of Hepatitis B treatment. It offers a flexible workflow suitable for various testing settings and delivers quality results in approximately one hour. However, it is not available in all countries, including the United States.

Goal
The primary goal is the elimination of Hepatitis by 2030. Viral hepatitis is a leading cause of death globally, comparable to HIV/AIDS, tuberculosis, or malaria, and is responsible for 80% of liver cancer cases. The WHO strategy aims to eliminate viral hepatitis as a major public health threat by 2030, requiring expanded service delivery to manage Hepatitis B Virus (HBV) effectively.

Need
Efficient treatment delivery is crucial as there is no cure for HBV, and lifelong treatment is necessary for those chronically infected. Rapid antibody testing is common at the point of care, but viral load testing traditionally occurs in laboratories with long turnaround times, risking patient follow-up and care. Expanded prevention, testing, and treatment services are needed.

Solution
The Xpert HBV Viral Load on the GeneXpert® System provides accurate and reliable quantification of HBV DNA in human serum or plasma. It offers flexible throughput for any testing setting with on-demand results, simplifying disease management with results available in less than an hour.

Impact
The system improves patient care by providing same-day results, increasing efficiency with high-quality quantitative results for accurate treatment delivery, and strengthening communities by reducing drug resistance and transmission. It is designed for both near-patient testing and high-throughput labs, offering rapid individual patient results and accommodating other urgent test requests.

System Features
The modular system adapts to any throughput requirement, from health clinics to national reference centers. It can be used as an indicator of disease prognosis and for assessing viral response to antiviral treatment in plasma and serum specimens, with rapid results provided in less than an hour.

Workflow
The workflow involves two easy steps with a total hands-on time of less than one minute: transferring at least 1 mL of plasma or serum into the cartridge, scanning, loading the cartridge, and starting the test.

Contact Information
Corporate Headquarters: 904 Caribbean Drive, Sunnyvale, CA 94089 USA. Toll-Free: +1.888.336.2743. Phone: +1.408.541.4191. Fax: +1.408.541.4192.
European Headquarters: Vira Solelh, 81470 Maurens-Scopont France. Phone: +33.563.82.53.00. Fax: +33.563.82.53.01. Email: [email protected]. Website: www.Cepheidinternational.com.

Reference
WHO Global Health Sector Strategy 2016-2021, June 2016.