Answering the Call for Hepatitis B Testing

Hepatitis B virus (HBV) infection has long been a public health concern. According to the World Health Organization (WHO), this infection led to an estimated 1.1 million deaths in 2022.¹ However, only 13% of people living with chronic Hepatitis B at that time had been diagnosed—and only 3% had been treated.²

Early diagnosis is important to help patients begin timely treatments. Laboratorians around the world are answering the call for increased HBV testing, and we are here to support you with our latest Access HBsAg assay.

It takes a strong combination of efficient workflows and clinical performance to keep pace with today’s growing HBV testing needs. Fortunately, these are two key components of our philosophy of Advantaged Workflows, which combines our products, services, and expertise to accelerate more precise clinical decision-making. To better understand how our latest Access HBsAg assay can help power Advantaged Workflows, our Immunoassay Product Manager, Jackie Smithee, asked Daniela Bernasconi, Infectious Disease Business Development Manager, to share her insights.

JS: Why is the demand for Hepatitis B testing growing in labs today?

DB: The call for testing is growing because, even though an effective vaccine is available, chronic Hepatitis B affects hundreds of millions of people, and the number of lives lost due to viral hepatitis is increasing.³ According to the WHO, in highly endemic areas, Hepatitis B is most commonly spread from mother to child at birth (vertical transmission), or through other exposure to infected blood (horizontal transmission).⁴ However, in 2022, only 45% of babies received the hepatitis B vaccine within 24 hours of birth.⁵ Many global programs are working to eliminate the disease, including through increased testing—particularly for pregnant people and high-risk individuals.

JS: Last year, the World Health Organization released updated guidelines for HBV testing. Can you tell us a bit about what has changed?

DB: The WHO has set a goal to eliminate Hepatitis B by 2030, focusing on scaling up viral hepatitis prevention, testing, and treatment to prevent liver diseases.⁴ In March 2024, the organization released updated guidelines for hepatitis B testing and treatment and introduced key changes making care more accessible, especially in places with limited resources. One of the biggest updates is the expanded and simplified treatment criteria, which now include adults and adolescents. That means more people can start treatment earlier and more easily. The guidelines also broaden access to antiviral prophylaxis during pregnancy, which is a big step toward preventing mother-to-child transmission. And beyond just who gets treated, the WHO is emphasizing the importance of delivering high-quality, integrated care—with strategies to help patients stay on therapy long term. The updates are about making sure people not only get diagnosed but also stay connected to care and treatment.

JS: What challenges are labs facing today when testing for the Hepatitis B virus?

DB: Laboratorians are constantly balancing the need for clinical confidence against the demand for efficient, high-throughput workflows to drive productivity. This is especially true when working with critical assays like hepatitis B surface antigen, which plays a crucial role in universal HBV screening for adults and during pregnancy. Many HBV testing protocols recommend confirmatory testing for reactive (positive) samples, and they often include expanded panels to improve accuracy. However, repeat testing can cost labs significant time and resources.

With a turnaround time (TAT) of 29 minutes, our latest Access HBsAg assay can help deliver results quickly, which can be particularly important in emergency situations such as testing for pregnant women who are unaware of their infectious status.

In addition to the rapid TAT, our validated HBsAg high-positive algorithm eliminates the need for repeat and confirmatory testing for samples ≥100.00 S/CO (signal-to-cutoff ratio).⁸ From a lab workflow perspective, that can mean time saved, reduced testing costs, and the ability to deliver results to physicians and patients quickly so they can begin appropriate treatments sooner. It also means greater confidence in the classification of results. These are all key benefits of Advantaged Workflows.

JS: How have you seen this come to life in labs so far?

DB: Several recent examples come to mind. San Jacopo Hospital in Pistoia, Italy, has felt the impact of the new Access HBsAg assay. This hospital, whose lab typically runs 6 million tests annually, implemented the new HBsAg assay on the DxI 9000 Immunoassay Analyzer.

They improved TAT efficiency by 36% with the HBsAg assay on the DxI 9000 compared to reference and some competitive assays. And beyond assay performance, the DxI 9000 analyzer offered additional workflow advantages. Notably, it required less than half the sample volume compared with the reference analyzer and assays.⁶ This feature can be particularly valuable to critical patients, where sample availability may be limited.

At another hospital, early results highlighted the value of the high-positive algorithm. This lab generally uses confirmatory testing for borderline samples, especially in postpartum women awaiting breastfeeding clearance, patients with biological risk, and transplant candidates. In three months of routine testing with the Access HBsAg assay, 8,751 tests were performed, with 2.64% (231 samples) showing results ≥ 100 S/CO. The high-positive algorithm led to a reduction in additional testing, saving time (TAT) and improving overall lab efficiency.⁷

These examples show that our new HBsAg assay can contribute to clinical impact while enhancing laboratory workflow. The increased accuracy means labs may be able to reduce reflex testing which, in turn, can help reduce turnaround times. And when we add in the DxI 9000 analyzer’s throughput (up to 450 tests per hour), high sensitivity, and disposable tips minimizing the risk of carryovers, labs can achieve faster, more confident results.

These workflow efficiencies do more than help labs operate more effectively; they also support timely and confident decision-making. By delivering  reliable results faster, the new Access HBsAg assay and the DxI 9000 analyzer can help  inform decision-making.

JS: Tell us more about the Access HBsAg assays.

DB: We designed these assays to deliver the sensitivity and specificity our customers need to be confident in their results. Hepatitis B infections are major causes of chronic liver disease.¹ These tests are crucial to help connect patients to the care they need, so healthcare providers need to be able to trust their results.

In product validation testing, our assay showed 99.92% specificity. 96.9% of initially reactive samples were ≥100.00 S/CO, eliminating the need for repeat and confirmatory testing. And with 100.00% sensitivity, all initially reactive results were confirmed positive using the Access HBsAg Confirmatory assay.⁸

These assays strongly support our philosophy of Advantaged Workflows, where clinical performance and operational efficiency go hand in hand.

JS: What else do you want laboratory teams to know about Advantaged Workflows?

DB: The philosophy is all about helping labs address their workflow challenges and find new ways to succeed. With rising sample volumes, increasing complexity, and labor constraints, every investment in the lab needs to support efficient and effective workflows.

We designed the DxI 9000 Immunoassay Analyzer to set a new standard for productivity. It has minimal maintenance requirements, and it is designed to streamline workflows with real-time error detection, instrument monitoring, and predictive analytics. When we combine this efficiency with a high-performing menu of assays, it’s a great solution to help labs put Advantaged Workflows into action.

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