OBJECTIVES Previous analytical evaluations of the Beckman Coulter Access high sensitivity troponin (hsTn) I assay have focused on single platforms and laboratory sites. The purpose of this study was to determine assay robustness across different platforms at multiple sites, platform-specific characteristics, and equivalence to other hsTn methods 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. Various studies were conducted across a total of 9 laboratories using Beckman DxI800 and Access2 platforms. RESULTS Within-laboratory precision was <10% across all target patient pool concentrations, however, DxI800 mean values were 20% higher than Access2 in the range of 3.6-44.9 ng/L. LOBs and LODs were lower on DxI800, 0.27 and 0.90 ng/L, respectively, compared to 2.9 and 3.2 ng/L, on Access2. Both showed excellent linearity across the full range. In method comparison to AccuTnI+3, DxI800 had a higher slope (0.9417 versus 0.8495) and positive bias (+18.1% versus -9.9%) compared to Access2, a trend further pronounced at concentrations <150 ng/L. At values <150 ng/L, there was good agreement with Abbott hsTnI (slope = 1.017, r = 0.932), but poor agreement with the Roche hsTnT assay (slope = 1.687, r = 0.589). Inter-laboratory split sample comparisons across 2 DxI800 and 7 Access2 sites showed close agreement, except at low concentrations <10 ng/L where DxI800 was 2.8 ng/L higher (p<0.001). CONCLUSIONS The Beckman hsTnI assay showed robust analytical performance across different laboratories and platforms. However, discrepancies between platforms were found at low concentrations where rapid acute myocardial infarction (AMI) rule-out decisions occur. These differences have important implications for AMI risk assessment, suggesting that laboratories should develop platform-specific parameters rather than using them interchangibly.

中文翻译：

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使用Barricor血浆在不同实验室位置对Beckman Coulter Access高灵敏度肌钙蛋白I测定进行多平台分析评估。

目标先前对Beckman Coulter Access高灵敏度肌钙蛋白（hsTn）I分析的分析评估集中在单个平台和实验室现场。这项研究的目的是确定跨多个站点的不同平台的测定稳健性，特定于平台的特征以及与大型实验室网络中其他hsTn方法的等效性。方法使用ric离子血浆评估不精确度，线性，灵敏度（空白和检测限，LOB / LOD）以及与常规AccuTnI + 3和其他hsTn测定法的可比性。使用Beckman DxI800和Access2平台在总共9个实验室中进行了各种研究。结果在所有目标患者池浓度中，实验室内的精密度均<10％，但是，DxI800的平均值在3.6-44范围内比Access2高20％。9 ng / L。与Access2上的2.9和3.2 ng / L相比，DxI800的LOB和LOD分别较低，分别为0.27和0.90 ng / L。两者在整个范围内均表现出出色的线性度。在与AccuTnI + 3的方法比较中，与Access2相比，DxI800具有更高的斜率（0.9417对0.8495）和正偏差（+ 18.1％对-9.9％），在浓度<150 ng / L时趋势更加明显。在值<150 ng / L时，与雅培hsTnI的一致性好（斜率= 1.017，r = 0.932），但与Roche hsTnT分析的一致性差（斜率= 1.687，r = 0.589）。在2个DxI800和7个Access2站点进行的实验室间分割样品比较显示出一致的结果，但低浓度<10 ng / L时DxI800高2.8 ng / L（p <0.001）。结论Beckman hsTnI测定法在不同实验室和平台上均显示出强大的分析性能。但是，发现平台之间的差异在低浓度时会发生快速急性心肌梗塞（AMI）排除决定。这些差异对AMI风险评估具有重要意义，表明实验室应该开发平台特定的参数，而不是可互换地使用它们。