BARCELONA, Spain, April 16,
2024 /PRNewswire/ -- Beckman Coulter Diagnostics, a
leader in clinical diagnostics, announced today, ahead of the
congress of the European Society of Clinical Microbiology and
Infectious Diseases (ESCMID Global), that it has extended the menu
of DxI 9000 Immunoassay Analyzer* assays. Recently, tests for
Hepatitis B and C viruses — namely Access anti-HCV, Access HBsAg,
and Access HBsAg Confirmatory assays — received CE marks.
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
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 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.
According to Kathleen Orland,
Senior Vice President, General Manager, Chemistry and Immunoassay
for Beckman Coulter Diagnostics, "By launching these new hepatitis
assays on our DxI 9000 Analyzer, 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."
Beckman Coulter chose ESCMID Global 2024, which will be taking
place between April 27th and 30th,
2024, in Barcelona, to
showcase these assays in public for the first time.
The assays are currently available in countries accepting CE
mark.
Follow and connect with Beckman Coulter via LinkedIn, X, and
Facebook.
About Beckman Coulter Diagnostics
A global leader in
advanced diagnostics, Beckman Coulter has challenged convention to
elevate the diagnostic laboratory's role in improving patient
health for more than 80 years. Our mission is to Relentlessly
Reimagine Healthcare, One Diagnosis at a Time – and we do this
by applying the power of science, technology and the passion and
creativity of our teams. Our diagnostic solutions are used in
complex clinical testing, and are found in hospitals, reference
laboratories and physician office settings around the globe. We
exist to deliver smarter, faster diagnostic solutions that move the
needle forward from what's now to what's next. We seek to
accelerate care with an extensive clinical menu, scalable lab
automation technologies, insightful clinical informatics, and
optimize lab performance services. Headquartered in Brea, California, with more than 11,000 global
team members, Beckman Coulter Diagnostics is proud to be part of
Danaher. Danaher is a global science and technology leader.
Together we combine our capabilities to accelerate the real-life
impact of tomorrow's science and technology to improve human
health.
*Full name DxI 9000 Access Immunoassay Analyzer
© 2024 Beckman Coulter. All rights reserved. Beckman Coulter,
the stylized logo, and the Beckman Coulter product and service
marks mentioned herein are trademarks or registered trademarks of
Beckman Coulter, Inc. in the United
States and other countries. Lumigen and the Lumigen product
marks mentioned herein are trademarks or registered trademarks of
Lumigen, Inc. in the United States
and other countries. Lumigen is a Beckman Coulter company. All
other trademarks are the property of their respective owners.
2024-12753
NOT ALL PRODUCTS ARE AVAILABLE IN ALL COUNTRIES
PRODUCT AVAILABILITY AND REGULATORY STATUS DEPENDS ON COUNTRY
REGISTRATION PER APPLICABLE REGULATIONS
IVD: In Vitro Diagnostic Products. These products are labelled "For
In Vitro Diagnostic Use"
CE-IVD, CE: Products intended for in vitro diagnostic use and
conforming to Vitro Diagnostic Medical Devices Regulation (EU)
2017/746 (IVDR)
NOTE: Devices may be CE marked to other directives than
(98/79/EC)
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SOURCE Beckman Coulter Diagnostics