Kupchak Peter, Wu Alan H B, Ghani Farooq, Newby L Kristen, Ohman E Magnus, Christenson Robert H
Nanogen, Point of Care Diagnostics Division, Toronto, Ontario, Canada.
Clin Chem. 2006 Apr;52(4):752-3. doi: 10.1373/clinchem.2005.064477. Epub 2006 Feb 9.
There has been considerable debate regarding the impact of assay imprecision on the performance of cardiac biomarkers for diagnosis of acute coronary syndromes (ACS) and risk stratification for future adverse cardiac events.
Using existing data from 2 published clinical trials, we used a resampling method to statistically introduce 5%, 10%, and 20% imprecision to results for B-type natriuretic peptide (BNP) and cardiac troponin I (cTnI) and examined its impact on ROC curve analysis.
Superimposition of artificial imprecision produced no significant difference in the area under the ROC curve observed for BNP for diagnosis of heart failure or for cTnI for 30-day risk stratification of patients with ACS.
Assay imprecision does not appear to be a critical determinant in the interpretation of cardiac marker results for patients with heart disease.
关于检测不精密度对用于急性冠状动脉综合征（ACS）诊断的心脏生物标志物性能以及未来不良心脏事件风险分层的影响，一直存在大量争论。
利用两项已发表临床试验的现有数据，我们采用重抽样方法，对B型利钠肽（BNP）和心肌肌钙蛋白I（cTnI）的结果在统计学上引入5%、10%和20%的不精密度，并检验其对ROC曲线分析的影响。
人工引入的不精密度对用于诊断心力衰竭的BNP或用于ACS患者30天风险分层的cTnI的ROC曲线下面积无显著差异。
检测不精密度似乎并非心脏病患者心脏标志物结果解读的关键决定因素。
