What are the diagnostic tests for Hepatitis B (HBV) diagnosis?

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From the Guidelines

Hepatitis B diagnosis should involve initial screening with blood tests for hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc), followed by additional tests including hepatitis B e antigen (HBeAg) and antibody (anti-HBe), hepatitis B viral load (HBV DNA), and liver function tests if HBsAg is positive. The diagnosis of hepatitis B infection is made or excluded on the basis of various serologic and viral markers, including HBsAg, anti-HBs, HBeAg, anti-HBc-IgM/G, and HBV-DNA 1.

Key Tests for Hepatitis B Diagnosis

  • HBsAg: indicates active infection
  • Anti-HBc: shows exposure to the virus
  • HBeAg and anti-HBe: determine infectivity
  • HBV DNA: measures viral replication
  • Liver function tests (ALT, AST, bilirubin, albumin): assess liver damage
  • Complete blood count and prothrombin time/INR: evaluate overall health and clotting function
  • Imaging studies like ultrasound, FibroScan, or FibroTest: assess liver damage and fibrosis
  • Liver biopsy: determines the extent of liver damage in some cases

According to the most recent and highest quality study, the persistence of HBsAg beyond 6 months of acute hepatitis B is adequate for a diagnosis of chronic hepatitis B 1. Regular monitoring is essential for patients with chronic hepatitis B to track disease progression and treatment effectiveness. The measurement of HBV-DNA is a particularly important guiding tool for the administration and monitoring of antiviral treatment 1.

Importance of Regular Monitoring

  • Track disease progression
  • Monitor treatment effectiveness
  • Adjust treatment plans as needed
  • Prevent complications and improve patient outcomes

In real-life clinical practice, it is crucial to prioritize the side of caution when the evidence is not very strong or equivocal, and make firm decisions based on the most recent and highest quality studies, such as 1, to ensure the best possible outcomes for patients with hepatitis B infection.

From the Research

Hepatitis B Diagnosis

Hepatitis B virus (HBV) infection is a major global health problem, and timely diagnosis is crucial to diminish its burden 2. The diagnosis of HBV infection involves serological and molecular tests.

Serological Tests

Serological markers, such as hepatitis B surface antigen (HBsAg) and anti-HBs, anti-HBc IgM and IgG, and hepatitis B e antigen (HBeAg) and anti-HBe, are used to detect antigens and antibodies in the blood 2, 3. HBsAg is the hallmark of HBV infection and is the first serological marker to appear in acute hepatitis B 3.

Molecular Tests

Molecular tests, such as quantitative or qualitative PCR, are used to verify the diagnosis, quantify viral load, and identify genotypes 2, 4. These tests are essential for monitoring liver disease activity, differentiating other etiologies of hepatitis activity, and predicting the risk of hepatocellular carcinoma (HCC) development or liver-related mortality 3.

Diagnostic Approach

The diagnostic approach for HBV infection involves:

  • Screening for HBsAg and anti-HBs in high-risk individuals 5
  • Detecting HBV DNA in serum or tissue to diagnose occult HBV infection 3
  • Monitoring serum HBV DNA levels to assess liver disease activity and predict the risk of HCC development 3
  • Using new biomarkers, such as hepatitis B virus core-related antigen (HBcrAg) and HBV RNA, to reflect intrahepatic cccDNA status 4

Laboratory Tests

Various laboratory tests are available for diagnosing HBV infection, including:

  • Electrochemiluminescence immunoassay (ECLIA) and enzyme-linked immunosorbent assay (ELISA) for detecting serum HBV markers 6
  • Quantitative PCR for measuring HBV DNA levels 3, 4
  • Genotyping tests to identify HBV genotypes 3

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Diagnosis of hepatitis B.

Annals of translational medicine, 2016

Research

Diagnosis of hepatitis B virus infection through serological and virological markers.

Expert review of gastroenterology & hepatology, 2008

Research

Current laboratory tests for diagnosis of hepatitis B virus infection.

International journal of clinical practice, 2021

Research

Comparison of two immunoassays for determining hepatitis B virus serum markers.

Clinical chemistry and laboratory medicine, 2011

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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