Odsæter Ingrid Hov, Grenne Bjørnar, Hov Gunhild Garmo, Laugsand Lars Erik, Wiseth Rune, Mikkelsen Gustav
Department of Clinical Chemistry, St. Olav's Hospital, Trondheim University Hospital, Trondheim, Norway.
Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.
Clin Chem Lab Med. 2020 Apr 10;58(9):1557-1563. doi: 10.1515/cclm-2019-1023. Print 2020 Aug 27.
The recommended cut-off of cardiac troponin (cTn) for the diagnosis of acute myocardial infarction (AMI) is the 99th percentile in a healthy reference population. We aimed to determine the 99th percentile of the novel ADVIA Centaur® High Sensitivity Troponin I assay (Siemens Healthcare Diagnostics) in fresh lithium heparin plasma samples from healthy blood donors.
A total of 1000 apparently healthy blood donors were included. High-sensitivity (hs) cTnI, hs-cTnT, creatinine and N-terminal pro b-type natriuretic peptide (NT-proBNP) were measured in fresh lithium heparin plasma samples, and glycated hemoglobin (HbA1c) was measured in ethylenediaminetetraacetic acid (EDTA)-blood. The 99th percentile was estimated for the whole population, as well as for males and females separately.
For the total population the 99th percentile of ADVIA Centaur® High Sensitivity Troponin I was 96 (65-149) ng/L. The estimated value differed significantly from results published by others and was highly dependent on which values were considered statistical outliers.
The estimated 99th percentile for hs-cTnI in the population studied differed significantly from previously published results. There is a need for further specifications regarding how subjects used for estimating the 99th percentile of cTns in healthy populations should be recruited and how outlier values should be identified, as this can highly influence the diagnostic cut-off applied for AMI.
用于诊断急性心肌梗死（AMI）的心脏肌钙蛋白（cTn）推荐临界值是健康参考人群中的第99百分位数。我们旨在确定新型ADVIA Centaur®高敏肌钙蛋白I检测法（西门子医疗诊断公司）在健康献血者新鲜肝素锂血浆样本中的第99百分位数。
共纳入1000名表面健康的献血者。在新鲜肝素锂血浆样本中检测高敏（hs）cTnI、hs-cTnT、肌酐和N末端B型利钠肽原（NT-proBNP），并在乙二胺四乙酸（EDTA）抗凝血中检测糖化血红蛋白（HbA1c）。分别估算总体人群以及男性和女性的第99百分位数。
总体人群中ADVIA Centaur®高敏肌钙蛋白I的第99百分位数为96（65 - 149）ng/L。该估算值与其他研究发表的结果显著不同，并且高度依赖于哪些值被视为统计异常值。
在所研究人群中，hs-cTnI的估算第99百分位数与先前发表的结果显著不同。对于健康人群中用于估算cTns第99百分位数的受试者应如何招募以及异常值应如何识别，需要进一步明确，因为这会对应用于AMI的诊断临界值产生很大影响。
