Department of Metabolic Biochemistry, La Pitié Salpêtrière-Charles Foix University Hospital (AP-HP), Paris, France.
Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, SSORG-Scandinavian Surgical Outcomes Research Group, Sahlgrenska University Hospital/Östra, Gothenburg, Sweden.
Clin Chem Lab Med. 2018 Apr 25;56(5):818-829. doi: 10.1515/cclm-2017-0256.
Detection of acute myocardial infarction (AMI) is mainly based on a rise of cardiac troponin with at least one value above the 99th percentile upper reference limit (99th URL). However, circulating high-sensitive cardiac troponin T (hs-cTnT) concentrations depend on age, sex and renal function. Using an analytical imprecision-based approach, we aimed to determine age- and sex-specific hs-cTnT 99th URLs for patients without chronic kidney disease (CKD).
A 3.8-year retrospective analysis of a hospital laboratory database allowed the selection of adult patients with concomitant plasma hs-cTnT (<300 ng/L) and creatinine concentrations, both assayed twice within 72 h with at least 3 h between measurements. Absence of AMI was assumed when the variation between serial hs-cTnT values was below the adjusted-analytical change limit calculated according to the inverse polynomial regression of analytical imprecision. Specific URLs were determined using Clinical and Laboratory Standards Institute (CLSI) methods, and partitioning was tested using the proportion method, after adjustment for unequal prevalences.
After outlier removal (men: 8.7%; women: 6.6%), 1414 men and 1082 women with estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m2 were assumed as non-AMI. Partitioning into age groups of 18-50, 51-70 and 71-98 years, the hs-cTnT 99th URLs adjusted on French prevalence were 18, 33, 66 and 16, 30, 84 ng/L for men and women, respectively. Age-partitioning was clearly required. However, sex-partitioning was not justified for subjects aged 18-50 and 51-70 years for whom a common hs-cTnT 99th URLs of about 17 and 31 ng/L could be used.
Based on a laboratory approach, this study supports the need for age-specific hs-cTnT 99th URLs.
急性心肌梗死（AMI）的检测主要基于心肌肌钙蛋白升高，至少有一个值高于第 99 百分位上限（99th URL）。然而，循环高敏心肌肌钙蛋白 T（hs-cTnT）浓度取决于年龄、性别和肾功能。本研究采用基于分析不精密度的方法，旨在确定无慢性肾脏病（CKD）的患者的年龄和性别特异性 hs-cTnT 99th URL。
对医院实验室数据库进行了 3.8 年的回顾性分析，入选同时有血浆 hs-cTnT（<300ng/L）和肌酐浓度的成年患者，在 72 小时内至少有 3 小时的两次检测，且两次检测之间的 hs-cTnT 值变化低于根据分析不精密度逆多项式回归计算的调整后分析变化限值。采用临床和实验室标准协会（CLSI）方法确定特定 URL，并根据不等患病率进行调整后，采用比例法进行分区检验。
去除离群值（男性：8.7%；女性：6.6%）后，假定 1414 名男性和 1082 名肾小球滤过率（eGFR）≥60mL/min/1.73m2 的女性非 AMI。将年龄分组为 18-50 岁、51-70 岁和 71-98 岁，调整法国患病率后的 hs-cTnT 99th URL 分别为男性和女性的 18、33、66 和 16、30、84ng/L。年龄分区是必要的。然而，对于年龄在 18-50 岁和 51-70 岁的患者，性别分区是不合理的，他们可以使用约 17 和 31ng/L 的共同 hs-cTnT 99th URL。
基于实验室方法，本研究支持使用年龄特异性 hs-cTnT 99th URL 的必要性。
