Department of Laboratory Medicine, Konventhospital Barmherzige Brueder Linz, Linz, Austria.
Department of Laboratory Medicine, Konventhospital Barmherzige Brueder Linz, Linz, Austria.
Clin Chim Acta. 2016 May 1;456:19-23. doi: 10.1016/j.cca.2016.02.014. Epub 2016 Feb 24.
Here we describe the determination of upper reference limits (URL) for galectin-3, high-sensitivity cardiac troponin I (hs-cTnI) and high-sensitivity cardiac troponin T (hs-cTnT) in a single cohort of healthy blood donors using routine assays.
For this reference value study, we used a cohort of 402 consecutive blood donors (64% were male and 36% were female). The median individuals' age was 35.0 years (range, 18.0-64.4). Individuals of this reference population were free of cardiovascular disease, diabetes mellitus, renal disease, cancer, current infection and chronic inflammatory disease. Plasma concentrations of galectin-3 were measured with the "routine Galectin-3" assay (Abbott Diagnostics), of hs-cTnI with the "STAT High Sensitive Troponin-I" assay (Abbott Diagnostics), and of hs-cTnT with the "Troponin T hs" assay (Roche Diagnostics). URLs were calculated by using a non-parametric percentile method.
The 97.5th percentile URL for galectin-3 was 16 ng/mL in males and 17 ng/mL in females; the 99 th percentile URL for hs-cTnI was 39 ng/L in males and 24 ng/L in females; and the 99 th percentile URL for hs-cTnT was 14 ng/L in males and 11 ng/L in females. Those individuals with hs-cTnI values ≥ 15 ng/L (n=8) were different from those individuals with hs-cTnT values ≥ 10 ng/L (n=7). Of the 402 individuals, none had galectin-3 values below the limit of detection (LOD, <1.0 ng/mL), 290 (72%) had hs-cTnI values below the LOD (i.e., 1.9 ng/L), and 359 (89%) had hs-cTnT values below the LOD (i.e., 5.0 ng/L).
Plasma concentrations of galectin-3, hs-cTnI and hs-cTnT and corresponding 99 th percentile URLs were rather low in our cohort of healthy blood donors compared with previously published data. In our reference population, analyte plasma concentrations above the LOD were detectable in 100% of the individuals with the Abbott galectin-3 assay, but only in less than 50% for both the Abbott hs-cTnI assay and the Roche hs-cTnT assay.
本研究旨在使用常规检测方法,在单个健康献血者队列中确定半乳糖凝集素-3、高敏心肌肌钙蛋白 I(hs-cTnI)和高敏心肌肌钙蛋白 T(hs-cTnT)的上参考限(URL)。
在这项参考值研究中,我们使用了 402 名连续献血者的队列(64%为男性,36%为女性)。中位个体年龄为 35.0 岁(范围为 18.0-64.4)。该参考人群中无心血管疾病、糖尿病、肾脏疾病、癌症、当前感染和慢性炎症性疾病。使用 Abbott Diagnostics 的“常规 Galectin-3”检测法测量半乳糖凝集素-3的血浆浓度,使用 Abbott Diagnostics 的“STAT 高敏肌钙蛋白-I”检测法测量 hs-cTnI 的血浆浓度,使用 Roche Diagnostics 的“Troponin T hs”检测法测量 hs-cTnT 的血浆浓度。通过使用非参数百分位数法计算 URL。
男性半乳糖凝集素-3的第 97.5 百分位 URL 为 16ng/mL,女性为 17ng/mL;男性 hs-cTnI 的第 99 百分位 URL 为 39ng/L,女性为 24ng/L;男性 hs-cTnT 的第 99 百分位 URL 为 14ng/L,女性为 11ng/L。那些 hs-cTnI 值≥15ng/L(n=8)的个体与那些 hs-cTnT 值≥10ng/L(n=7)的个体不同。在 402 名个体中,无半乳糖凝集素-3值低于检测限(LOD,<1.0ng/mL),290 名(72%)hs-cTnI 值低于 LOD(即 1.9ng/L),359 名(89%)hs-cTnT 值低于 LOD(即 5.0ng/L)。
与先前发表的数据相比,我们健康献血者队列中半乳糖凝集素-3、hs-cTnI 和 hs-cTnT 的血浆浓度及其相应的第 99 百分位 URL 相对较低。在我们的参考人群中,使用 Abbott 半乳糖凝集素-3 检测法,可在 100%的个体中检测到分析物血浆浓度高于 LOD,但 Abbott hs-cTnI 检测法和 Roche hs-cTnT 检测法中,仅有不到 50%的个体可检测到。