New CE-Marked Hepatitis Assays to Help Diagnose Infections Earlier

According to the World Health Organization (WHO), an estimated 354 million individuals globally are afflicted with chronic hepatitis B or C. These viruses are the leading causes of liver cirrhosis, liver cancer, and deaths related to viral hepatitis, affecting hundreds of millions. Early detection plays a crucial role in initiating timely treatments that improve long-term health outcomes. The detection of the hepatitis B virus surface antigen (HBsAg) in serum or plasma is an early indicator of infection. HBsAg is the first serological marker to appear in the progression of the disease, emerging in the blood two to three weeks before symptoms become apparent. Traditional testing protocols typically require retesting and subsequent confirmatory tests for reactive samples. Now, two newly introduced hepatitis assays use advanced technology to elevate efficiency and confidence in hepatitis testing.

Beckman Coulter Diagnostics (Brea, CA, USA) has extended the menu of DxI 9000 Immunoassay Analyzer assays with new tests for Hepatitis B and C viruses — namely Access anti-HCV, Access HBsAg, and Access HBsAg Confirmatory assays. The company’s validated HBsAg High Positive algorithm removes the need for repeat and confirmatory testing for samples with results ≥ 100.00 S/CO. This allows 96.9% of initially reactive samples to be directly reported as positive, thereby providing laboratories with prompt and accurate results. The assay is designed both as an aid in diagnosing HBV infections and as a screening test for blood and plasma donors.

Leveraging the success of its DxI 9000 Analyzer, Beckman Coulter is now advancing the efficiency and reliability of hepatitis testing. This advancement underscores the analyzer's ability to develop increasingly sensitive and clinically relevant assays, meeting current needs and anticipating future diagnostic requirements in healthcare. The DxI 9000 Analyzer incorporates cutting-edge technologies such as ZeroDaily Maintenance, PrecisionVision Technology, Lumi-Phos PRO, SimpleSolve Onboard Guide, and DxS IntelliServe. These innovations enhance Beckman Coulter's new infectious disease assays, increasing confidence in accurate diagnostics and timely management of diseases. Beckman Coulter’s new Access anti-HCV, Access HBsAg, and Access HBsAg Confirmatory assays have received CE marks.

"By launching these new hepatitis assays on our DxI 9000 Analyzer, we can deliver exceptional quality,” said 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."

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