DxI 9000 analyzer achieves Six Sigma performance for high-sensitivity Troponin I measurement

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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