DxI 9000 Access Immunoassay Analyzer

The updated 2024 CLIA proficiency testing (PT) criteria, the first major change since 1992, tightens goals by up to 40%, raising quality challenges for laboratories. Current data shows many diagnostic instruments achieve only two to three sigma, risking PT failures under the new standards. The Beckman Coulter DxI 9000 analyzer stands out with Six Sigma performance, helping labs meet the 2024 criteria, reduce quality control workload, and optimize processes with fewer Westgard Rules.

This resource is shared as part of the global CLINICAL24 conversation. Visit the Innovation Hub to learn more about high-sensitivity immunoassay advances.

The Beckman Coulter DxI 9000 analyzer features advanced technology like the Lumi-Phos PRO substrate, an upgraded luminometer, and precise low-volume pipetting, which enhances assay sensitivity. These improvements enable reduced sample and reagent volumes, conserving patient samples, minimizing packaging waste, and increasing tests per reagent pack. Studies on Access TSH, βhCG, and PSA assays show analytical performance is maintained with decreased volumes. This supports efficient, resource-conserving immunoassay development while maintaining performance standards.

This resource is shared as part of the global CLINICAL24 conversation. Visit the Innovation Hub to learn more about high-sensitivity immunoassay advances.

In July 2024, the Clinical Laboratory Improvement Act (CLIA) established proficiency testing (PT) quality standards for Troponin I, a previously non-CLIA-regulated analyte. In this study by the Westgard QC group†, performance of Troponin I PT was evaluated on six instrument platforms: Abbott ARCHITECT, Beckman Coulter Unicel DxI, Roche e600 Ser/E170, Siemens Atellica IM HS, Vitros 36/56/76.Eci/Q, and the Beckman Coulter DxI 9000 Immunoassay Analyzer*.

The study found:

• The DxI 9000 analyzer achieved >90% Six Sigma performance for high-sensitivity Troponin I (hsTnI) measurement in both Troponin I lithium heparin and Troponin I serum samples
• The hsTnI assay on the DxI 9000 analyzer easily exceeds CLIA 2024’s new PT criteria
• The Beckman Coulter Unicel DxI analyzer achieved >3 Sigma for hsTnI measurement

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Kevin O’Reilly, President of Beckman Coulter Diagnostics, reflects on two years of progress since the launch of the DxI 9000 Analyzer at EuroMedLab 2023. This high-sensitivity, high-throughput immunoassay analyzer — capable of testing up to 450 samples per hour — has since been enhanced with over 61 new assays, covering key clinical areas including cardiac health, sepsis, anemia, reproductive health, and infectious disease.

In this exclusive EuroMedLab 2025 update, O’Reilly also reveals groundbreaking advancements in blood-based testing for Alzheimer’s disease, including a Breakthrough Device Designation from the FDA for Beckman Coulter’s p-tau217 / Aβ1-42 assay. This test aims to replace expensive and invasive diagnostics like PET scans and lumbar punctures with scalable, community-accessible blood testing.

Beckman Coulter’s global R&D teams are leading innovation in neurodegenerative biomarkers, collaborating with the Davos Alzheimer’s Collaborative and Global Alzheimer’s Task Force to bring precision diagnostics to more patients, sooner.

Watch now to see how Beckman Coulter is transforming access to Alzheimer’s diagnostics and redefining core lab performance.

This video was filmed at EuroMedLab2025.

Join Beckman Coulter Diagnostics as it enters an exciting era of clinical innovation. The company's new President, Kevin O’Reilly, shares his vision for advancing Beckman Coulter Diagnostics with groundbreaking technologies like the award-winning DxI 9000.

Discover how Beckman Coulter is revolutionizing clinical diagnostics through enhanced reliability, automation, and workflow efficiency. Learn about the company's commitment to making significant clinical impacts, including the development of a blood-based Alzheimer's biomarker test.

This video was filmed at ADLM 2024 and is shared as part of the global CLINICAL24 conversation. .

Beckman Coulter Immunoassay and Beckman Coulter Microbiology have joined forces at ESCMID Global to introduce the DxI 9000 Immunoassay Analyzer where the company launched a brand-new suite of blood virus assays to the public. This new suite of assays complements the Microbiology portfolio to provide mechanisms for early detection and confirmation of bacterial and viral infections to improve patient outcomes. Discover how Beckman Coulter Diagnostics is transforming the landscape of diagnostic testing, offering a patient-centric approach with unprecedented accuracy, efficiency, and reliability.

This video was filmed at ESCMID Global 2024.

Guest editorial by Arindam Ghosh, MBBS, PhD, a physician-scientist by training with extensive experience in neurodegenerative and neuropsychiatric disorders, particularly Alzheimer’s disease and dementia

Guest editorial by Mark Holland, Ph.D. Director, Bioinformatics/Biostatistics for Chemistry and Immunoassay Research and Development, Beckman Coulter

Thermo Fisher Scientific, Beckman Coulter Clinical Diagnostics, and LGC Clinical Diagnostics among those recognized