Beckman Coulter Diagnostics has announced an expanded DxI 9000 Immunoassay Analyzer menu, with tests for hepatitis B and C viruses - namely Access anti-HCV, Access HBsAg, and Access HBsAg Confirmatory assays - receiving CE marks.
The announcement comes ahead of Beckman Coulter Diagnostics’ presence at the European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global) meeting, to be held in Barcelona on 27-30 April 2024, where these assays will be showcased in public for the first time.
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 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.
Kathleen Orland, Senior Vice President, General Manager, Chemistry and Immunoassay for Beckman Coulter Diagnostics, commented: “By launching these new hepatitis assays on our DxI 9000 analyser, 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."
The assays are currently available in countries accepting the CE mark.