Analytical evaluation of a high-sensitivity troponin T assay and its clinical assessment in acute coronary syndrome
Analytical evaluation of a high-sensitivity troponin T assay and its clinical assessment in acute coronary syndrome
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DOI：
10.1258/acb.2011.011019
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发表时间：
2011-09-01
影响因子：
2.2
通讯作者：
Lefevre, Guillaume
中科院分区：
文献类型：
--
作者：
Chenevier-Gobeaux, Camille;Meune, Christophe;Lefevre, Guillaume
背景资料：最近开发的高灵敏度心肌肌钙蛋白T（hs-cTnT）免疫测定提高了急性心肌梗死（AMI）的检测。然而，这种方法需要进一步的分析和临床evaluation.Methods：不精密度，线性，定量限和干扰进行了评价，hs-cTnT与传统的心肌肌钙蛋白I测定（cTnI），进行了比较，在一个人口的患者与疑似AMI的X-pand（R）HM。结果：不精密度分析表明变异系数（CV）小于4%，线性相关系数为0.999，回收率为99.9%，定量限（CV）为9.2ng/L。当补充血红蛋白高于0.25 g/dL时，观察到对溶血的负干扰（>20%）。可疑AMI患者hs-cTnT升高（83%）明显高于cTnI升高（55%，P < 0.01）。63%的hs-cTnT升高但cTnI未升高的患者存在不稳定型心绞痛。我们参考人群的第99百分位值为16.9 ng/L。213例健康献血员血清hs-cTnT水平与年龄显著相关（P <0.0001），男性高于女性（P < 0.0001）。确定样本中的溶血程度对于hs-cTnT结果的解释至关重要。建立了我们参考人群的第99百分位值。
Background: The recently developed, highly sensitive cardiac troponin T (hs-cTnT) immunoassay improves the detection of acute myocardial infarction (AMI). However, this assay requires further analytical and clinical evaluation.Methods: Imprecision, linearity, limits of quantification and interferences were evaluated; hs-cTnT was compared with a conventional cardiac troponin I assay (cTnI), performed on an X-pand (R) HM, in a population of patients with suspected AMI. Finally, the 99th percentile cut-off point for a reference population was explored in 213 healthy control subjects.Results: Imprecision analysis demonstrated coefficients of variation (CVs) below 4%, linearity showed a 0.999 coefficient of correlation, with excellent recovery (99.9%) and a limit of quantification (10%CV) was found at 9.2 ng/L. A negative interference (>20%) with haemolysis was observed when supplemental haemoglobin was above 0.25 g/dL. Patients with suspected AMI more frequently displayed an increased hs-cTnT (83%) than an increased cTnI (55%, P < 0.01). Unstable angina was present in 63% of patients with an increased hs-cTnT associated with no increase in cTnI. The 99th percentile value for our reference population was 16.9 ng/L. In 213 healthy blood donors, hs-cTnT levels were significantly correlated with age (P < 0.0001), and were higher in men than in women (P < 0.0001).Conclusions: The analytical performance of hs-cTnT complied with the international guidelines for AMI detection. Determining the degree of haemolysis in a sample is of paramount importance to the interpretation of hs-cTnT results. The 99th percentile value of our reference population was established.