Beckman introduces novel CE-Marked Hepatitis Assays at ESCMID Global

Published: 17-Apr-2024

The HBsAg high positive algorithm eliminates the need for repeat and confirmatory testing for samples ≥ 100.00 S/CO

Beckman Coulter Diagnostics, a clinical diagnostics specialist, has announced 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 Analyser 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’s 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. 

354 million people worldwide live with chronic hepatitis B or C

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 Analyser, Beckman Coulter is elevating efficiency and confidence for hepatitis testing. This milestone reinforces the DxI 9000 Analyser’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.

Capitalising on the unique technologic advancements of the DxI 9000 Analyser, 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.

Beckman Coulter chose ESCMID Global 2024 to showcase these assays in public for the first time. The assays are currently available in countries accepting CE mark.

 

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