Jossi S, Gordon S L, Legge M A, Armstrong G P
Department of Clinical Chemistry, North Shore Hospital, Takapuna, Auckland, New Zealand.
Intern Med J. 2006 May;36(5):325-7. doi: 10.1111/j.1445-5994.2006.01073.x.
Troponin measurement is central to the management and risk stratification of acute coronary syndromes. Decisions are made by categorizing troponin as positive or negative. We sought to evaluate categorical agreement between four troponin assays. Sixty blood samples were analysed by three troponin I assays (Centaur, Architect and point-of-care i-STAT) and one troponin T (TnT) assay (Roche Elecys). The upper reference limit was taken as the lowest value with a coefficient of variation of 10% or less. Continuous agreement between assays was good (Pearson's correlation coefficient 0.871-0.995). Categorical agreement assessed by Cohen's kappa varied from poor (between Architect and Centaur kappa = 0.37, and between TnT and Centaur kappa = 0.48) to good (between Architect and i-STAT kappa = 0.68, and between TnT and i-STAT kappa = 0.68). Percentage of positive results varied almost twofold, from 37% for the Centaur to 72% for the Architect. Comparison of four troponin assays showed up to twofold variations in the proportion of positive results. This implies that either a large proportion of troponin-positive diagnoses are missed by some assays or the assays with higher positivity are generating large numbers of false positives. Clinicians should evaluate troponin results in the clinical context and not base decisions solely on the 'normal range' of their local troponin assay.
肌钙蛋白检测对于急性冠脉综合征的管理和风险分层至关重要。通过将肌钙蛋白分类为阳性或阴性来做出决策。我们旨在评估四种肌钙蛋白检测方法之间的分类一致性。对60份血样进行了三种肌钙蛋白I检测(Centaur、Architect和即时检验i-STAT)和一种肌钙蛋白T(TnT)检测(罗氏Elecys)。将变异系数为10%或更低的最低值作为参考上限。各检测方法之间的连续一致性良好(皮尔逊相关系数为0.871 - 0.995)。通过科恩kappa系数评估的分类一致性从较差(Architect和Centaur之间kappa = 0.37,TnT和Centaur之间kappa = 0.48)到良好(Architect和i-STAT之间kappa = 0.68,TnT和i-STAT之间kappa = 0.68)不等。阳性结果的百分比几乎相差两倍,从Centaur的37%到Architect的72%。四种肌钙蛋白检测方法的比较显示,阳性结果的比例差异高达两倍。这意味着要么某些检测方法遗漏了很大一部分肌钙蛋白阳性诊断,要么阳性率较高的检测方法产生了大量假阳性。临床医生应在临床背景下评估肌钙蛋白结果,而不应仅基于当地肌钙蛋白检测的“正常范围”来做决策。