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17th April 2024  Content supplied by: Beckman Coulter Inc.

Beckman Coulter’s New CE-Marked Hepatitis Assays at ESCMID Global


Beckman Coulter's HBsAg High Positive Algorithm for Hepatitis B Detection

  • Beckman Coulter's validated HBsAg High Positive algorithm eliminates the need for repeat and confirmatory testing for samples ≥ 100.00 S/CO.
  • The DxI 9000 Analyzer is being used to develop increasingly sensitive and clinically relevant assays.
  • Beckman Coulter's infectious disease assays boost confidence in accurate reporting and timely disease management.

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 to aid in diagnosing 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 contributes 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 the CE mark.

Visit Beckman Coulter for more or use the Request Information button below to connect with the company.

 *Full name DxI 9000 Access Immunoassay Analyzer


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Date Published: 17th April 2024

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