Beckman Coulter Diagnostics has extended the menu of DxI 9000 Immunoassay Analyser assays, with tests for Hepatitis B and C viruses — Access anti-HCV, Access HBsAg, and Access HBsAg Confirmatory assays — receiving CE marks.
Building on the strengths and success of the Analyzer, Beckman Coulter is elevating efficiency and confidence for hepatitis testing, reinforcing the instrument’s ability to develop increasingly sensitive and clinically relevant assays, keeping pace with today’s needs and tomorrow’s testing requirements as healthcare providers strive to detect evermore challenging diseases. The assays will be showcased for the first time at ESCMID Global 2024, in Barcelona, from April 27 to 30.
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, and will be available in countries accepting CE mark.
The technologic advancements adds to existing DxI 9000 Analyzer features, such as ZeroDaily Maintenance, PrecisionVision Technology, Lumi-Phos PRO, SimpleSolve Onboard Guide, and DxS IntelliServe.
Kathleen Orland, Senior Vice President, General Manager, Chemistry and Immunoassay for Beckman Coulter Diagnostics, said: “By launching these new hepatitis assays on our DxI 9000 Analyzer, we can deliver exceptional quality. 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."
