Clinical Chemistry Laboratory, Cochin and Hôtel-Dieu Hospitals, Assistance Publique des Hôpitaux de Paris, Paris, France.
Ann Clin Biochem. 2011 Sep;48(Pt 5):452-8. doi: 10.1258/acb.2011.011019. Epub 2011 Jun 22.
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.
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(®)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.
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).
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.
最近开发的高敏心肌肌钙蛋白 T（hs-cTnT）免疫分析法提高了急性心肌梗死（AMI）的检测能力。然而，该检测方法需要进一步进行分析和临床评估。
评估不精密度、线性、定量下限和干扰；比较 hs-cTnT 与在 X-pand(®)HM 上进行的传统心肌肌钙蛋白 I 检测（cTnI）在疑似 AMI 患者人群中的结果。最后，在 213 名健康对照者中探讨了参考人群的第 99 百分位截断值。
不精密度分析显示变异系数（CVs）低于 4%，线性相关系数为 0.999，回收率极好（99.9%），定量下限（10%CV）为 9.2ng/L。当补充血红蛋白高于 0.25g/dL 时，观察到溶血的负干扰（>20%）。疑似 AMI 患者中 hs-cTnT 升高的比例（83%）显著高于 cTnI 升高的比例（55%，P<0.01）。hs-cTnT 升高但 cTnI 无升高的患者中，不稳定型心绞痛占 63%。我们参考人群的第 99 百分位值为 16.9ng/L。在 213 名健康献血者中，hs-cTnT 水平与年龄显著相关（P<0.0001），且男性高于女性（P<0.0001）。
hs-cTnT 的分析性能符合 AMI 检测的国际指南。确定样本中溶血的程度对 hs-cTnT 结果的解释至关重要。我们参考人群的第 99 百分位值已建立。
