New CE-marked hepatitis assays unveiled at ESCMID Global

Beckman Coulter Diagnostics, a leader in clinical diagnostics, has unveiled an expanded menu of assays for the DxI 9000 Immunoassay Analyzer ahead of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global) congress. The new tests for Hepatitis B and C viruses, including Access anti-HCV, Access HBsAg, and Access HBsAg Confirmatory assays, have received CE marks, signifying their adherence to stringent European regulatory standards.

Detection of the viral surface antigen (HBsAg) in serum or plasma serves as a crucial indicator of hepatitis B virus (HBV) infection. Beckman Coulter's validated HBsAg High Positive algorithm streamlines testing processes by eliminating the need for repeat and confirmatory testing for reactive patient samples with high accuracy. With 96.9% of initially reactive samples ≥ 100.00 S/CO directly reported as positive, laboratories can rely on precise results, thereby facilitating early diagnosis and screening for blood and plasma donors.

By utilising the proven capabilities of the DxI 9000 Analyzer, Beckman Coulter aims to enhance efficiency and confidence in hepatitis testing. The addition of these assays underscores the platform's versatility in developing sensitive and clinically relevant tests to meet evolving healthcare needs. As chronic hepatitis B and C infections continue to pose significant global health challenges, early diagnosis facilitated by advanced diagnostics is paramount for improved patient outcomes.

Kathleen Orland, Senior Vice President and General Manager of Chemistry and Immunoassay for Beckman Coulter Diagnostics, emphasised the company's commitment to delivering exceptional quality through advanced technology. The newly introduced hepatitis assays, along with the DxI 9000 Analyzer's innovative features such as ZeroDaily Maintenance and PrecisionVision Technology, empower healthcare professionals to make informed decisions and contribute to better patient care.

Beckman Coulter will showcase these ground-breaking assays for the first time at ESCMID Global 2024, scheduled from 27 to 30 April 2024, in Barcelona. The assays are currently available in countries accepting CE marks, providing healthcare providers with reliable tools for accurate disease management.

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