Raizman Joshua E, Tsui Albert K Y, Goudreau Bobbi-Lynn, Füzéry Anna K, Estey Mathew, Sadrzadeh Hossein, Higgins Trefor
Alberta Precision Laboratories, North Sector, Edmonton, Alberta, Canada; Department of Laboratory Medicine & Pathology, University of Alberta, Edmonton, Alberta, Canada.
Alberta Precision Laboratories, North Sector, Edmonton, Alberta, Canada; Department of Laboratory Medicine & Pathology, University of Alberta, Edmonton, Alberta, Canada.
Clin Biochem. 2020 Apr;78:25-31. doi: 10.1016/j.clinbiochem.2019.10.014. Epub 2019 Nov 16.
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.
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.
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).
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.
先前对贝克曼库尔特Access高敏肌钙蛋白（hsTn）I检测法的分析评估主要集中在单一平台和实验室站点。本研究的目的是确定在多个站点的不同平台上该检测法的稳健性、平台特定特征，以及在大型实验室网络中与其他hsTn检测方法的等效性。
使用Barricor血浆评估不精密度、线性、灵敏度（空白限和检测限，LOB/LOD），以及与传统的AccuTnI+3和其他hsTn检测法的可比性。在总共9个使用贝克曼DxI800和Access2平台的实验室中进行了各种研究。
在所有目标患者群体浓度范围内，实验室内精密度均<10%，然而，在3.6 - 44.9 ng/L范围内，DxI800的平均值比Access2高20%。DxI800的LOB和LOD较低，分别为0.27和0.90 ng/L，而Access2的为2.9和3.2 ng/L。两者在整个范围内均显示出良好的线性。在与AccuTnI+3的方法比较中，与Access2相比，DxI800的斜率更高（0.9417对0.8495）且有正偏差（+18.1%对 -9.9%），在浓度<150 ng/L时这种趋势更明显。在<150 ng/L的值时，与雅培hsTnI有良好的一致性（斜率 = 1.017，r = 0.932），但与罗氏hsTnT检测法一致性较差（斜率 = 1.687，r = 0.589）。在2个DxI800和7个Access2站点间的实验室间分割样本比较显示出密切一致性，但在<10 ng/L的低浓度时除外，此时DxI800高2.8 ng/L（p<0.001）。
贝克曼hsTnI检测法在不同实验室和平台上显示出稳健的分析性能。然而，在快速排除急性心肌梗死（AMI）的低浓度时发现了平台间的差异。这些差异对AMI风险评估具有重要意义，表明实验室应制定特定于平台的参数，而不是可互换地使用它们。
