Summary: Beckman Coulter Diagnostics has expanded the menu of assays for its DxI 9000 Access Immunoassay Analyzer with the recent CE marking of tests for hepatitis B and C viruses. 


  1. The new hepatitis assays, including Access anti-HCV, Access HBsAg, and Access HBsAg Confirmatory assays, offer enhanced efficiency and accuracy in detecting viral infections, particularly hepatitis B, by eliminating the need for repeat and confirmatory testing for certain samples.
  2. The availability of advanced assays on the DxI 9000 Analyzer facilitates accurate and timely detection, empowering healthcare providers to manage hepatitis infections more effectively.
  3. Beckman Coulter’s DxI 9000 Analyzer is equipped with advanced features such as ZeroDaily Maintenance, PrecisionVision Technology, Lumi-Phos PRO, SimpleSolve Onboard Guide, and DxS IntelliServe.

Beckman Coulter Diagnostics has extended the menu of DxI 9000 Access Immunoassay Analyzer assays, following an announcement that tests for hepatitis B and C viruses—namely Access anti-HCV, Access HBsAg, and Access HBsAg Confirmatory assays—recently received CE marks.

Detection of Hepatitis

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.

The assays are currently available in countries accepting CE mark.

Capabilities of the DxI 9000 Analyzer

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 company.

Scope of Chronic Hepatitis B or C

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.

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.

“By launching these new hepatitis assays on our DxI 9000 Analyzer, we can deliver exceptional quality,” says Kathleen Orland, senior vice president, general manager, Chemistry and Immunoassay for Beckman Coulter Diagnostics. “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.”

Further reading: Beckman Coulter Unveils New Clinical Chemistry Analyzer

Beckman Coulter will showcase these assays in public for the first time at the European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global).

Featured image: The DxI 9000 Analyzer innovations address today’s speed, reliability, reproducibility, quality, and menu expansion demands. Photo: Beckman Coulter