High-Sensitivity HBV DNA Testing: Pre-NAT II Automated Nucleic Acid Platform
A Science-Backed Overview of Hepatitis B Virus Quantitative Detection and the VirtueDx Pre-NAT II System
Hepatitis B virus (HBV) infection, commonly known as hepatitis B, is a viral infection of the liver caused by the hepatitis B virus, encompassing both acute and chronic forms. Hepatitis B is a liver-damaging viral infection that can cause acute or chronic disease. The virus is most commonly transmitted from mother to child during birth and delivery, and during early childhood. Other transmission routes include sexual contact with an infected partner, exposure to blood or other body fluids, unsafe injections, and contact with contaminated sharp instruments [1].
The World Health Organization (WHO) estimates that in 2019, 296 million people worldwide were living with chronic hepatitis B infection, with 1.5 million new infections occurring each year. In 2019, hepatitis B caused approximately 820,000 deaths, primarily from cirrhosis and hepatocellular carcinoma (primary liver cancer). However, hepatitis B can be prevented through safe, accessible, and effective vaccines [2].
The hepatitis B epidemiological situation in China remains severe. China's HBV prevalence rate is 5.6%, with HBsAg-positive cases reaching 79.75 million. The diagnosis and treatment rates are only 24% and 15%, respectively. A 2014 survey by the Chinese Center for Disease Control and Prevention (CDC) found that the HBsAg positivity rate among individuals aged 1 to 29 in China was 2.94%, and 0.32% among children under 5 years old. According to estimates by the Polaris International Epidemiology Collaborative, the HBsAg prevalence rate in the general Chinese population in 2016 was 6.1%, with 86 million chronic HBV infection cases [3].
| Metric | Global | China |
|---|---|---|
| Chronic HBV infections | 296 million (2019) | 79.75–86 million |
| HBsAg prevalence rate | 3.8% | 5.6%–6.1% |
| Annual new infections | 1.5 million | Not specified |
| Annual HBV-related deaths | 820,000 | Not specified |
| Diagnosis rate | 10% | 24% |
| Treatment rate | 2% | 15% |
High-sensitivity HBV DNA quantitative testing offers significant advantages over conventional detection methods, particularly for patients with low viral loads who are at risk of false-negative results with standard assays.
Advantage 1 — Superior Analytical Performance
High-sensitivity HBV DNA reagents provide high sensitivity, strong specificity, excellent accuracy, and a wider quantitative linear range compared to conventional assays.
Advantage 2 — Reduced False Negatives for Low Viral Loads
For patients with low-level HBV infection, conventional HBV DNA detection may produce false-negative results. High-sensitivity testing significantly improves detection precision, ensuring accurate diagnosis even at very low viral concentrations.
Advantage 3 — Enhanced Treatment Monitoring
High-sensitivity HBV DNA testing enables more accurate detection of low-level hepatitis B viral loads, facilitating precise treatment efficacy monitoring and supporting clinical decision-making for treatment endpoint determination [4].
The 2022 edition of the Guidelines for the Prevention and Treatment of Chronic Hepatitis B, published by the Chinese Society of Hepatology, explicitly states that for HBsAg-positive individuals — including patients with chronic hepatitis B (CHB) currently receiving antiviral therapy — high-sensitivity HBV DNA nucleic acid detection methods with a large quantitative linear range should be used whenever possible, with a lower limit of quantification of 10–20 IU/mL [5].
Based on recent research advances in antiviral therapy for chronic hepatitis B and the practical needs of clinical diagnosis and treatment, the Chinese Society of Hepatology has developed expert recommendations advising expanded HBsAg screening in the population and the adoption of high-sensitivity HBV DNA detection methods [6].
The VirtueDx Pre-NAT II automated nucleic acid extraction system is built upon three core features — high sensitivity, full automation, and wide linear range — focusing on early screening and disease monitoring to provide timely and reliable diagnostic results for clinical laboratories and central testing facilities.
Pre-NAT II High-Sensitivity HBV DNA Quantitative Detection Kit
High Sensitivity
Detection lower limit of 10 IU/mL, enabling more accurate detection of low-concentration virus, precise treatment endpoint determination, and avoidance of missed detections.
Full Automation Platform
Fully automated process from nucleic acid extraction of primary tube samples through PCR reaction system setup, eliminating manual operations and improving detection stability and reproducibility.
Wide Linear Range
Quantitative range of 20 IU/mL to 10^9 IU/mL, enabling precise quantification of low-concentration samples and direct quantification of high-concentration samples without dilution steps.
| Parameter | Specification |
|---|---|
| Detection lower limit | 10 IU/mL |
| Quantitative linear range | 20 IU/mL – 10^9 IU/mL |
| Automation level | Fully automated (extraction through PCR setup) |
| Sample type | Primary tube (original collection tube) |
| Dilution required | No — direct quantification across full range |
Key Takeaways
- Hepatitis B remains a major global health burden, with 296 million chronic infections worldwide and 79.75–86 million in China alone — yet diagnosis and treatment rates remain critically low.
- High-sensitivity HBV DNA testing (lower limit 10–20 IU/mL) is essential for accurate low-viral-load detection, reducing false negatives, and enabling precise treatment monitoring.
- The 2022 Chinese Society of Hepatology guidelines explicitly recommend high-sensitivity HBV DNA nucleic acid detection methods for all HBsAg-positive patients, including those on antiviral therapy.
- The VirtueDx Pre-NAT II platform combines 10 IU/mL sensitivity, full automation from extraction to PCR setup, and a wide linear range (20 IU/mL to 10^9 IU/mL) — eliminating dilution steps and manual operations.
- Expanded HBsAg screening combined with high-sensitivity HBV DNA detection is the recommended strategy for improving hepatitis B diagnosis and treatment outcomes.
References
[1] WHO. Global Progress Report on HIV, Viral Hepatitis and Sexually Transmitted Infections, 2021. Available at: https://www.who.int/publications/i/item/9789240027077.
[2] Gane EJ, Charlton MR, Mohamed R, et al. Asian consensus recommendations on optimizing the diagnosis and initiation of treatment of hepatitis B virus infection in resource-limited settings. J Viral Hepat, 2020, 27(5): 466–475.
[3] Chinese Society of Infectious Diseases, Chinese Society of Hepatology. Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 Edition). Chinese Journal of Hepatology, 2022, 30(12): 1309–1331.
[4] European Association for the Study of the Liver. EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection. J Hepatol, 2017, 67(2): 370–398.
[5] Chinese Society of Infectious Diseases, Chinese Society of Hepatology. Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 Edition). Chinese Journal of Hepatology, 2022, 30(12): 1309–1331.
[6] Chinese Society of Hepatology. Expert Opinions on Expanding Antiviral Therapy for Chronic Hepatitis B. Chinese Journal of Hepatology, 2022, 30(2): 131–136.
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