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Hepatitis test solutionsDiagnostics built to deliver confidence

Hepatitis remains a major global public health challenge, with over 300 million people living with chronic hepatitis B or C worldwide, according to the World Health Organization (WHO).1 Despite being preventable and treatable, viral hepatitis causes more than 1.3 million deaths annually.1 Timely, accurate, and accessible testing are important to improving patient outcomes and advancing public health initiatives.2

Benefits

Our hepatitis solutions deliver trusted clinical performance and broad detection capabilities on a platform engineered for high-powered intelligent automation and workflow efficiency, supporting patients and clinicians in the fight against viral hepatitis.

Built to simplify workflows without compromising clinical confidence, our hepatitis solutions combine high performance assays with intelligent automation to support efficient and reliable decision making.

  • Reduced need for repeat testing: Our HBsAg II assay is the only infectious disease assay with a secondary cut-off,3 at an index >50 and is built to streamline laboratory operations by reducing the need for duplicate repeat testing and improving workflow.
  • Built-in workflow intelligence for efficiency: The Atellica Data Manager includes hepatitis algorithms that can help automate and simplify testing by facilitating assay-specific instructions for use. The lab can apply different configurations to customize the workflow and meet your needs.

Hepatitis testing can be labor-intensive and disrupt routine workflows. By consolidating a comprehensive infectious disease portfolio on the Atellica Solution, built for high performance, laboratories can streamline operations, reduce workflow interruptions, and expand testing capacity without added complexity.

The Atellica IM Analyzer software optimizes its dual incubation ring by automatically assigning longer-incubation assays, such as infectious disease testing, to the internal ring while reserving the outer ring for shorter-incubation routine and STAT assays. This intelligent workflow management system enables you to consolidate hepatitis as well as routine and STAT assays on the Atellica Solution without compromising turnaround time.4

Hepatitis assays require high analytical performance to support accurate aid to diagnosis and patient management. Our commitment to assay innovation on the Atellica IM System combines deep scientific expertise with rigorous Six Sigma optimization, disposable sample tip technology, and proprietary Acridinium Ester (AE) chemistry for enhanced precision, sensitivity, and specificity. Together, these design elements provide reliable results to support confident clinical decision making.

Built to simplify workflows without compromising clinical confidence, our hepatitis solutions combine high performance assays with intelligent automation to support efficient and reliable decision making.

  • Reduced need for repeat testing: Our HBsAg II assay is the only infectious disease assay with a secondary cut-off,3 at an index >50 and is built to streamline laboratory operations by reducing the need for duplicate repeat testing and improving workflow.
  • Built-in workflow intelligence for efficiency: The Atellica Data Manager includes hepatitis algorithms that can help automate and simplify testing by facilitating assay-specific instructions for use. The lab can apply different configurations to customize the workflow and meet your needs.

Hepatitis Testing Overview

Hepatitis A5,6

Hepatitis A cannot be distinguished from other acute viral hepatitis based on symptoms alone, making laboratory testing important for aiding in diagnosis. Detection of HAV-specific IgM antibodies is commonly used to identify recent infection, while HAV total antibody testing detects both IgM and IgG antibodies, supporting assessment of prior exposure or immunity from past infection or vaccination. While molecular testing can identify early infection, routine diagnosis and clinical management are typically supported by widely accessible serological assays.

Hepatitis B7-9

Hepatitis B virus (HBV) consists of an outer lipid envelope and an icosahedral nucleocapsid core enclosing viral DNA and a reverse transcriptase DNA polymerase. This viral structure forms the basis for multiple serological markers used as an aid in diagnosing HBV infection, assessing immune status, and supporting patient monitoring.

Hepatitis C10,11

There is currently no vaccine to prevent the hepatitis C virus (HCV). Nearly 75-85% of people with hepatitis C are asymptomatic, increasing the importance of routine testing.13Without testing, individuals may be unaware they have the disease, may not receive available and effective treatment, and could unknowingly transmit HCV to others. Anti-HCV antibodies may not provide immunity against reinfection. Therefore, reinfection, especially in high-risk groups, is possible.

Atellica IM Portfolio

Hepatitis Menu

Hepatitis A

HAV IgM, HAV Total

Hepatitis B

Anti-HBe 2, Anti-HBs 2, HBc IgM, HBc Total 2, HBeAg, HBsAg II, HBsAg II Quant*, HBsAg II Confirmatory

Hepatitis C

aHCV

*
Not available in the U.S.

Evidence

Testimonials

“The integration of serological tests, such as hepatitis, on the same automation as urgent assays had no negative impact on turnaround times. On the contrary, we observed an improvement, even for critical assays like Troponin I.”
Dr. Carole Chirica
Dr. Carole Chirica
University Hospital of Grenoble, France
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Product availability may vary from country to country and is subject to varying regulatory requirements. Please contact your local representative.
The statements by the Siemens Healthineers customers described herein are based on results that were achieved in the customer's unique setting. Because there is no “typical” hospital or laboratory and many variables exist (e.g., hospital size, sample mix, case mix, level of IT and/or automation adoption), there can be no guarantee that other customers will achieve the same results.
1
Global hepatitis report 2024: action for access in low- and middle-income countries. World Health Organization. Available from https://www.who.int/publications/i/item/9789240091672. [accessed 2026 Jan]
2
G. Papatheodoridis, et al., “Addressing barriers to the prevention, diagnosis and treatment of hepatitis B and C in the face of persisting fiscal constraints in Europe: report from a high-level conference,” (in English), J. Viral Hepat. 23 (2016) 1–1.
3
Atellica IM HBsII assay instructions for use. Siemens Healthcare Diagnostics Inc. 10995358_EN Rev. 08, 2025-12
4
Real World Assessment of the Impact of Infectious Disease Assays on Workflow Capabilities of Atellica IM Analyzer White Paper QR700010799 07-2024
5
Hepatitis A. World Health Organization. Available from: https://www.who.int/news-room/fact-sheets/detail/hepatitis-a. [accessed 2026 Mar]
6
Clinical Screening and Diagnosis for Hepatitis A. CDC. Available from: https://www.cdc.gov/hepatitis-a/hcp/diagnosis-testing/index.html. [accessed 2026 Mar]
7
Hepatitis B Surveillance Guidance. CDC. Available from: https://www.cdc.gov/hepatitis/php/surveillance-guidance/hepatitis-b.html. [accessed 2026 Mar]
8
Understanding Your Test Results. Hepatitis B Foundation. Available from: https://www.hepb.org/prevention-and-diagnosis/diagnosis/understanding-your-test-results/. [accessed 2026 Mar]
9
Guidelines for the prevention, diagnosis, care and treatment for people with chronic hepatitis B infection. World Health Organization. Available from: https://www.who.int/publications/i/item/9789240090903. [accessed 2026 Mar]
10
Testing for HCV Infection: An Update of Guidance for Clinicians and Laboratorians. CDC. Available from: https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6218a5.htm. [accessed 2026 Mar]
11
Hepatitis C Surveillance Guidance. CDC. Available from: https://www.cdc.gov/hepatitis/php/surveillance-guidance/hepatitis-c.html. [accessed 2026 Mar]
12
Training workshop on screening, diagnosis and treatment of hepatitis B and C. World Health Organization. Available from: https://cdn.who.int/media/docs/default-source/searo/hiv-hepatitis/training-modules/08-hbv-serological-markers.pdf?sfvrsn=b4ca38a4_2. [accessed 2026 Mar]
13
CDC Clinical Screening and Diagnosis for Hepatitis C. CDC. Available from: https://www.cdc.gov/hepatitis-c/hcp/diagnosis-testing/index.html. [accessed 2026 Mar]
14
Interpretation of Results of Tests for Hepatitis C Virus (HCV) Infection and Further Actions. CDC. Available from: https://www.cdc.gov/hepatitis-c/media/pdfs/2025/08/hcv_graph_New.pdf. [accessed 2026 Mar]
15
CDC Viral Hepatitis Among People with HIV. CDC. Available from: https://www.cdc.gov/hepatitis/hcp/populations-settings/hiv.html. [accessed 2026 Jun]
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