Kavsak Peter A, Sharif Sameer, Demian Wael L, Choi Won-Shik, Belley-Cote Emilie P, Taher Jennifer, Shea Jennifer L, Blank David W, Knauer Michael, Thorlacius Laurel, Raizman Joshua E, Huang Yun, Beriault Daniel R, Fung Angela W S, Yip Paul M, Clark Lorna, Abramson Beth L, Friedman Steven M, McLaren Jesse, Atkinson Paul, Chen-Tournoux Annabel, Suskin Neville, Sivilotti Marco L A, Thiruganasambandamoorthy Venkatesh, Scheuermeyer Frank, Humphries Karin H, Aakre Kristin M, Mondoux Shawn E, Ainsworth Craig, Borges Flavia, Worster Andrew, McRae Andrew, Jaffe Allan S
Faculty of Health Sciences, McMaster University, Hamilton, ON L8N 3Z5, Canada.
Population Health Research Institute, Hamilton, ON L8L 2X2, Canada.
Diagnostics (Basel). 2025 Jun 28;15(13):1652. doi: 10.3390/diagnostics15131652.
In the emergency setting, many diagnostic pathways incorporate change in high-sensitivity cardiac troponin (hs-cTn) concentrations (i.e., the delta) to classify patients as low-risk (rule-out) or high-risk (rule-in) for possible myocardial infarction (MI). However, the impact of analytical variation on the delta for correct classification is unknown, especially at concentrations below and around the 99th percentile. Our objective was to assess the impact of delta variation for correct risk classification across the European Society of Cardiology (ESC 0/1 h and 0/2 h), the High-STEACS, and the common change criteria (3C) pathways. : A yearlong accuracy study for hs-cTnT was performed where laboratories across Canada tested three patient-based samples (level 1 target value = 6 ng/L, level 2 target value = 9 ng/L, level 3 target value = 12 ng/L) monthly across 41 different analyzers. The assigned low-delta between levels 1 and 2 was 3 ng/L (i.e., 9 - 6 = 3 ng/L) and the assigned high-delta between levels 1 and 3 was 6 ng/L (i.e., 12 - 6 = 6 ng/L). The low- and high-deltas for each analyzer were determined monthly from the measured values, with the difference calculated from the assigned deltas. The obtained deltas were then assessed via the different pathways on correct classification (i.e., percent correct with 95% confidence intervals, CI) and using non-parametric analyses. : The median (interquartile range) difference between the measured versus assigned low-delta (n = 436) and high-delta (n = 439) was -1 ng/L (-1 to 0). The correct classification differed among the pathways. The ESC 0/1 h pathway yielded the lowest percentage of correct classification at 35.3% (95% CI: 30.8 to 40.0) for the low-delta and 90.0% (95% CI: 86.8 to 92.6) for the high-delta. The 3C and ESC 0/2 h pathways yielded higher and equivalent estimates on correct classification: 95.2% (95% CI: 92.7 to 97.0) for the low-delta and 98.2% (95% CI: 96.4 to 99.2) for the high-delta. The High-STEACS pathway yielded 99.5% (95% CI: 98.4 to 99.9) of correct classifications for the high-delta but only 36.2% (95% CI: 31.7 to 40.9) for the low-delta. : Analytical variation will impact risk classification for MI when using hs-cTn deltas alone per the pathways. The 3C and ESC 0/2 h pathways have <5% misclassification when using deltas for hs-cTnT in this dataset. Additional studies with different hs-cTnI assays at concentrations below and near the 99th percentile are warranted to confirm these findings.
在急诊情况下，许多诊断路径采用高敏心肌肌钙蛋白（hs-cTn）浓度的变化（即差值）来将患者分类为可能发生心肌梗死（MI）的低风险（排除）或高风险（纳入）。然而，分析变异对用于正确分类的差值的影响尚不清楚，尤其是在低于和接近第99百分位数的浓度时。我们的目的是评估差值变异对欧洲心脏病学会（ESC 0/1小时和0/2小时）、High-STEACS以及通用变化标准（3C）路径中正确风险分类的影响。：进行了一项为期一年的hs-cTnT准确性研究，加拿大各地的实验室每月在41台不同分析仪上对三个基于患者的样本（1级目标值 = 6 ng/L，2级目标值 = 9 ng/L，3级目标值 = 12 ng/L）进行检测。1级和2级之间指定的低差值为3 ng/L（即9 - 6 = 3 ng/L），1级和3级之间指定的高差值为6 ng/L（即12 - 6 = 6 ng/L）。每月根据测量值确定每个分析仪的低差值和高差值，并从指定的差值计算差值。然后通过不同路径对获得的差值进行正确分类评估（即95%置信区间的正确百分比，CI）并使用非参数分析。：测量的与指定的低差值（n = 436）和高差值（n = 439）之间的中位数（四分位间距）差值为 -1 ng/L（-1至0）。不同路径的正确分类有所不同。ESC 0/1小时路径在低差值时正确分类的百分比最低，为35.3%（95% CI：30.8至40.0），在高差值时为90.0%（95% CI：86.8至92.6）。3C和ESC 0/2小时路径在正确分类方面产生了更高且相当的估计值：低差值时为95.2%（95% CI：从92.7至97.0），高差值时为98.2%（95% CI：96.4至99.2）。High-STEACS路径在高差值时正确分类的比例为99.5%（95% CI：98.4至99.9），但在低差值时仅为36.2%（95% CI：31.7至40.9）。：仅根据这些路径单独使用hs-cTn差值时，分析变异会影响MI的风险分类。在该数据集中，使用hs-cTnT差值时，3C和ESC 0/2小时路径的错误分类率<5%。有必要进行更多关于第99百分位数以下和附近浓度的不同hs-cTnI检测的研究来证实这些发现。
