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

The analytical Sigma metric provides information on potential future problems with proficiency testing and optimization of quality control procedures, including the number of Westgard rules, control levels, and reduced quality control frequency. The Westgard group also identified the highest proportion of Six Sigma assays on the DxI 9000 analyzer compared against competitor assays and analyzers.

At Beckman Coulter, we are committed to revolutionizing the next generation in immunoassay testing with precision and sensitivity to drive innovations, advance medical insights, and enhance diagnostic availability.

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Learn more about Beckman Coulter’s hsTnI assay here here

^†This study was funded by Beckman Coulter

*Full name DxI 9000 Access Immunoassay Analyzer