Multi-platform analytical evaluation of the Beckman Coulter Access high-sensitivity troponin I assay across different laboratory sites using Barricor plasma

Abstract Objectives Previous analytical evaluations of the Beckman Access high sensitivity troponin (hsTn) I assay have focused on single platforms and laboratories. The purpose of this study was to determine assay robustness across different platform models at multiple sites, platform-specific characteristics, and equivalence to other hsTn methods to be used in a large laboratory network. Methods Barricor plasma was used to assess imprecision, linearity, sensitivity (limit of blank and detection, LOB/LOD), and comparability to the conventional AccuTnI+3 and other hsTn assays. Studies were conducted in at least 3 laboratories using multiple DxI800 and Access2 platforms. Results Within-laboratory precision was Conclusions The Beckman hsTnI assay showed robust analytical performance across different laboratories/platforms. Excellent precision and sensitivity make it suitable for accelerated AMI protocols. However, discrepancies in assay performance between platforms can lead to major errors when using rapid rule-out algorithm.