Beckman Coulter’s DxI 9000 Immunoassay Analyzer Extends Menu with New CE-Marked Hepatitis Assays at ESCMID Global


Barcelona, April 16, 2024  — Beckman Coulter Diagnostics, a leader in clinical diagnostics, announced today, ahead of the congress of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global), that it has extended the menu of DxI 9000 Immunoassay Analyzer* assays. Recently, tests for Hepatitis B and C viruses — namely Access anti-HCV, Access HBsAg, and Access HBsAg Confirmatory assays — received CE marks.

Detection of the viral surface antigen (HBsAg) in serum or plasma indicates an infection caused by hepatitis B virus (HBV). It is the first serological marker to appear during the course of the disease and may be present in the blood two to three weeks before clinical symptoms appear. Current protocols often require retesting and then confirmatory testing for reactive patient samples. Beckman Coulter’s validated HBsAg High Positive algorithm eliminates the need for repeat and confirmatory testing for samples ≥ 100.00 S/CO with 96.9% of initially reactive samples being able to be directly reported as positive providing laboratories with accurate results.  The assay is intended to be used as an aid in the diagnosis of HBV infection and as a screening test for blood and plasma donors.

Building on the strengths and global success of the DxI 9000 Analyzer, Beckman Coulter is elevating efficiency and confidence for hepatitis testing. This milestone reinforces the DxI 9000 Analyzer’s capability to develop increasingly sensitive and clinically relevant assays, enabling the platform to keep pace with today’s needs and tomorrow’s testing requirements as healthcare providers strive to detect evermore challenging diseases. 

According to the World Health Organization (WHO), an estimated 354 million people worldwide live with chronic hepatitis B or C. Together, hepatitis B and C are the most common cause of liver cirrhosis, liver cancer, and viral hepatitis-related deaths, impacting hundreds of millions of people. Early diagnosis is a key contributor to patients beginning timely treatments, allowing for better long-term health outcomes.

Capitalizing on the unique technologic advancements of the DxI 9000 Analyzer, ZeroDaily Maintenance, PrecisionVision Technology, Lumi-Phos PRO, SimpleSolve Onboard Guide, and DxS IntelliServe, Beckman Coulter’s newly introduced infectious disease assays boost confidence in accurate reporting and timely disease management. 

According to Kathleen Orland, Senior Vice President, General Manager, Chemistry and Immunoassay for Beckman Coulter Diagnostics, “By launching these new hepatitis assays on our DxI 9000 Analyzer, we can deliver exceptional quality. Together, our advanced technology allows for accurate and timely detection, enabling healthcare professionals to diagnose infections earlier and promote better patient outcomes. Our commitment to providing reliable diagnostics empowers healthcare providers to make informed decisions and ultimately contributes to a safer and healthier community." 

Beckman Coulter chose ESCMID Global 2024, which will be taking place between April 27th and 30th, 2024, in Barcelona, to showcase these assays in public for the first time. 

The assays are currently available in countries accepting CE mark. 

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About Beckman Coulter Diagnostics

A global leader in advanced diagnostics, Beckman Coulter has challenged convention to elevate the diagnostic laboratory’s role in improving patient health for more than 80 years. Our mission is to Relentlessly Reimagine Healthcare, One Diagnosis at a Time – and we do this by applying the power of science, technology and the passion and creativity of our teams. Our diagnostic solutions are used in complex clinical testing, and are found in hospitals, reference laboratories and physician office settings around the globe. We exist to deliver smarter, faster diagnostic solutions that move the needle forward from what’s now to what’s next. We seek to accelerate care with an extensive clinical menu, scalable lab automation technologies, insightful clinical informatics, and optimize lab performance services. Headquartered in Brea, California, with more than 11,000 global team members, Beckman Coulter Diagnostics is proud to be part of Danaher. Danaher is a global science and technology leader. Together we combine our capabilities to accelerate the real-life impact of tomorrow’s science and technology to improve human health.



Maria Paccagnani 
European Public Relations 
Beckman Coulter Diagnostics

 *Full name DxI 9000 Access Immunoassay Analyzer 

© 2024 Beckman Coulter. All rights reserved. Beckman Coulter, the stylized logo, and the Beckman Coulter product and service marks mentioned herein are trademarks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries. Lumigen and the Lumigen product marks mentioned herein are trademarks or registered trademarks of Lumigen, Inc. in the United States and other countries. Lumigen is a Beckman Coulter company. All other trademarks are the property of their respective owners. 2024-12753

IVD: In Vitro Diagnostic Products. These products are labelled "For In Vitro Diagnostic Use
CE-IVD, CE: Products intended for in vitro diagnostic use and conforming to Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR)
NOTE: Devices may be CE marked to other directives than (98/79/EC)