SSD Biochimica ad Elevata Automazione, Azienda Ospedaliero-Universitaria di Parma, Via Gramsci 14, 43126 Parma, Italy.
SSD Biochimica ad Elevata Automazione, Azienda Ospedaliero-Universitaria di Parma, Via Gramsci 14, 43126 Parma, Italy.
Clin Chim Acta. 2019 May;492:26-28. doi: 10.1016/j.cca.2019.01.028. Epub 2019 Jan 31.
The detection of an increase and/or decrease of cardiac troponin (cTnI) values, with at least one value above the 99th percentile of the upper reference limit (URL) have a central role in acute myocardial infarction (AMI) diagnosis. The employment of sex specific 99th percentile URLs and High-sensitivity (Hs) assays are recommended. We assessed sex specific 99th percentile URL for Access Hs-cTnI and AccuTnI3+ (Beckman Coulter) using European donor reference population following recent International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) recommendations.
300 males and 300 females plasma samples were collected. Both chemiluminescent immunoenzymatic assays were performed on UniCel DxI 800 platform (Beckman Coulter).
For Access hsTnI, the observed sex-specific 99th percentile URLs were 5.5 (90% CI: 4.4-7.6) for females and 13.9 ng/L (90% CI: 7.4-17.4) for males. For AccuTnI+3 we could not establish them because the assay couldn't report detectable values of troponin for most of the analyzed samples.
The sex-specific 99th percentile URLs established for Access hsTnI assay were significantly lower than those declared by the manufacturer caused by the different choice of population selection, age groups and sample types: for those reasons, we maintain the 99th URLs provided by manufacturer.
肌钙蛋白 I（cTnI）值的升高和/或降低，至少有一个值高于 99%上限参考值（URL），在急性心肌梗死（AMI）诊断中具有核心作用。建议使用性别特异性 99%URL 和高敏（Hs）检测法。我们根据最近国际临床化学和实验室医学联合会（IFCC）的建议，使用欧洲供体参考人群评估了 Access Hs-cTnI 和 AccuTnI3+（贝克曼库尔特）的性别特异性 99%URL。
收集了 300 名男性和 300 名女性的血浆样本。两种均采用化学发光免疫酶联测定法在 UniCel DxI 800 平台（贝克曼库尔特）上进行检测。
对于 Access hsTnI，观察到的性别特异性 99%URL 分别为女性 5.5（90%CI：4.4-7.6）ng/L 和男性 13.9 ng/L（90%CI：7.4-17.4）ng/L。对于 AccuTnI+3，我们无法确定其 99%URL，因为该检测法无法报告分析样本中大多数可检测到的肌钙蛋白值。
Access hsTnI 检测法确定的性别特异性 99%URL 明显低于制造商声明的 URL，这是由于人群选择、年龄组和样本类型的不同造成的：基于这些原因，我们保留制造商提供的 99%URL。
