Viral Hepatitis: Why Accurate Diagnosis Is Key to Global Health

Viral hepatitis—especially hepatitis B (HBV) and hepatitis C (HCV)—continues to pose a major global health threat and remains one of the most pressing global health challenges. Despite decades of research and public health efforts, millions of people worldwide continue to live with chronic infections, often unaware of their status. And without treatment, hepatitis infection can lead to serious complications, including liver cirrhosis and hepatocellular carcinoma (HCC). As emphasized in Prof. Stéphane Chevaliez's recent Association for Diagnostics & Laboratory Medicine (ADLM) webinar, accurate and accessible diagnostic testing is the gateway to effective treatment and disease elimination.

A Silent Epidemic

HBV and HCV are major causes of chronic liver disease, cirrhosis, and hepatocellular carcinoma (HCC)—now the sixth most common cancer worldwide and the third leading cause of cancer-related deaths.¹ Alarmingly, only 1 in 10 people infected with hepatitis B are aware of their condition and even fewer receive treatment.² This lack of awareness contributes to late diagnoses, poor treatment outcomes, and continued transmission.

Hepatitis by the Numbers²

• 304 million people living with chronic hepatitis
  • 254 million with HBV
  • 50 million with HCV
• New infections decreased from 3 million in 2019 to 2.2 million in 2022
  • 1.2 million HBV
  • 1 million HCV
• Diagnosis gap: Only 13% of people with HBV and 36% with HCV are diagnosed
• Treatment gap: Only 3% and 20% of those diagnosed, respectively, have received curative treatment
• Deaths: The estimated number of deaths from viral hepatitis increased from 1.1 million to 1.3 million between 2019 and 2022
  • 83% from HBV
  • 17% from HCV

These numbers reflect a persistent global burden, with the highest prevalence in Africa, Asia, and parts of Europe. The clinical stakes are particularly high in resource-limited settings. In sub-Saharan Africa, where HBV serves as the predominant cause of HCC, patients are diagnosed at much younger ages with significantly shorter survival rates compared to Europe and North America. These disparities underscore how gaps in screening and early detection directly impact patient outcomes.

Without intervention, projections indicate deaths from chronic viral hepatitis will surpass those from tuberculosis, HIV, and malaria by 2040.³

Why Diagnosis Matters

The WHO has set a lofty goal to eliminate viral hepatitis by 2030 by increasing testing services, expanding prevention strategies—including those targeting vertical transmission—and providing equitable access to treatment for those infected with hepatitis viruses.^{2, 4-5} Accurate diagnosis is the cornerstone of effective hepatitis management, enabling:

• Early detection before symptoms emerge
• Timely treatment to prevent liver damage
• Monitoring of treatment efficacy
• Safer medical procedures by identifying active infections
• Prevention of transmission in high-risk populations

With highly effective treatments now available, the biggest barrier to hepatitis elimination is diagnostic access. Scaling up testing—especially in underserved and high-risk populations—is essential to meet the WHO's 2030 goal.

Yet there is hope. Hepatitis B vaccination has achieved remarkable success in infants—more than 80% coverage with three doses, reducing chronic infection prevalence from 5% to less than 1%.⁶ For hepatitis C, modern treatments have transformed the disease into a curable condition. The key to unlocking these therapeutic advances lies in accurate, timely diagnosis.

Despite technological advances, gaps remain. There are still low screening rates among adults, especially in high-risk groups, limited access to testing in low-resource settings, and a lack of awareness around testing that hinders people from going in for testing.

Understanding the Diagnostic Toolkit

Prof. Chevaliez emphasized that effective hepatitis management requires a comprehensive understanding of available diagnostic markers. These biomarkers serve three essential functions: identifying patients with viral hepatitis, enabling appropriate treatment decisions, and monitoring antiviral response.

Serological Assays

Serological assays remain the first line for large-scale screening. Modern immunoassay platforms using enzyme immunoassay (EIA) or chemiluminescent immunoassay (CLIA) technology offer excellent analytical performance. For HBsAg detection, ultra-sensitive assays with analytical sensitivity as low as 0.005 IU/mL enable detection of even low-level infections. The evolution of anti-HCV testing—from first-generation assays in 1989 to fourth-generation tests—has progressively reduced the diagnostic window period, enabling earlier detection.

Molecular Assays

Molecular assays based on real-time PCR or transcription-mediated amplification (TMA) represent the standard of care for confirming diagnosis, guiding treatment decisions, and evaluating therapeutic response. These platforms require high sensitivity (≥95%), specificity (99%), and low limits of detection (≤10-15 IU/mL) to reliably predict disease progression and confirm sustained virologic response.

Changing the Outcome

Hepatitis C (HCV)

The introduction of direct-acting antivirals (DAAs) has revolutionized HCV treatment. These oral medications are well-tolerated and highly effective:

• Cure rates exceed 95% with 8–12 weeks of DAA therapy⁷
• In real-world studies, SVR (sustained virological response) was achieved in 89.6% of patients treated with sofosbuvir-based regimens. Modified regimens pushed success rates to over 90%, even among patients with cirrhosis.⁸

Hepatitis B (HBV)

While HBV cannot yet be cured, antiviral therapy significantly improves outcomes:

• Functional cure—defined as sustained loss of HBsAg—is achieved in up to 39.9% of patients after 144 weeks of interferon-based therapy⁹
• Patients with low baseline HBsAg (<100 IU/mL) had cure rates nearing 59% within 96 weeks^9,10
• Nucleos(t)ide analogs like tenofovir and entecavir effectively suppress viral replication and reduce liver inflammation, decreasing the risk of liver complications¹¹

Integrated Testing Algorithms with Serological and Molecular Assays

Integrated testing algorithms streamline the diagnostic process and are essential for efficient patient care. For HCV, a positive antibody test is followed by reflex testing for HCV RNA or core antigen to confirm active infection. For HBV, a combination of HBsAg, anti-HBs, and anti-HBc provides a full infection profile.

These algorithms are especially vital for high-risk populations—including people who inject drugs, prisoners, and individuals co-infected with HIV—where timely diagnosis can significantly improve outcomes.

The Access Advantage for Hepatitis Testing

The Beckman Coulter DxI 9000 Access Immunoassay Analyzer exemplifies how modern diagnostic platforms meet the demanding requirements of viral hepatitis testing. Access Infectious Disease Assays deliver the sensitivity, specificity, and reliability clinicians need for confident diagnostic decisions.

Random access capability means laboratories can process urgent hepatitis screens alongside routine testing without batching delays, reducing turnaround times and enabling faster clinical action. This flexibility is particularly valuable in settings serving high-risk populations where timely diagnosis prevents transmission and enables earlier intervention. For laboratories implementing reflex testing algorithms—where positive antibody screens automatically trigger confirmatory testing—the DxI 9000 platform's integration capabilities streamline workflows and reduce manual touchpoints.

The Future of Hepatitis Diagnostics

To address remaining gaps, the future of hepatitis diagnostics lies in simplification and decentralization. Innovations like self-testing, point-of-care RNA detection, and ultra-sensitive assays are paving the way for broader access and earlier intervention.

To learn more about how Beckman Coulter Access Infectious Disease Assays can support your hepatitis testing needs, visit our Infectious Disease Solutions page or contact your Beckman Coulter representative

The ADLM webinar "Integrated Hepatitis Testing: What's New in Viral Hepatitis Diagnosis and Management?" featuring Prof. Stéphane Chevaliez is available on demand at https://myadlm.org/education/all-webinars/webinars/2025/october/integrated-hepatitis-testing