Department of Small Animal Clinical Sciences, School of Veterinary Medicine and Biomedical Sciences, Texas A&M University, College Station, TX, United States of America.
PLoS One. 2023 Jul 18;18(7):e0288801. doi: 10.1371/journal.pone.0288801. eCollection 2023.
Cardiac troponin I (cTnI) is considered the gold standard biomarker for myocardial injury and shows a high degree of homology between humans and dogs. The ADVIA Centaur XP High-Sensitivity Troponin I (AC-cTnI-HS) assay has been validated for use in humans but not dogs. The study objectives were to analytically validate the AC-cTnI-HS assay in dogs, to assess correlation between the AC-cTnI-HS and a previous ADVIA Centaur TnI-Ultra (AC-cTnI-U) assay, to assess cTnI sample storage stability, and to clinically evaluate the AC-cTnI-HS assay in healthy dogs and dogs with cardiac disease. Canine serum samples were used for analytical validation. Intra- and inter-assay variability, dilutional parallelism, and spiking recovery were assessed. Samples from 196 client-owned dogs were evaluated (healthy dogs (n = 39) or dogs with congenital heart disease (n = 54), myxomatous mitral valve disease (n = 68), dilated cardiomyopathy (n = 15), or myocarditis (n = 20)). Inter- and intra-assay coefficient of variation (%CV) was between 2.8-41.4% and 3.8-30.2%, respectively, with pools with concentrations >20 pg/mL all having %CVs <10%. The observed to expected ratios for dilutional parallelism and spiking recovery experiments ranged between 92.3 and 266.7.0% and 84.3 and 108%, respectively. A strong correlation between the AC-cTnI-HS and AC-cTnI-U assays was observed (Spearman's ρ = 0.927), though a proportional bias existed, with AC-cTnI-HS assay concentrations being proportionally lower than AC-cTnI-U assay concentrations. Serum samples stored at -80°C had stable cTnI measurements for up to 2.7 years and after a single freeze-thaw cycle. Healthy dogs and dogs with congenital heart disease had significantly lower cTnI concentrations than dogs in the other three groups. The AC-cTnI-HS assay precisely, reproducibly, and accurately measures cTnI concentrations in dog serum with cTnI concentrations >20 pg/mL.
心肌肌钙蛋白 I（cTnI）被认为是心肌损伤的金标准生物标志物，在人类和犬类之间具有高度同源性。ADVIA Centaur XP 高敏肌钙蛋白 I（AC-cTnI-HS）检测法已在人类中得到验证，但尚未在犬类中得到验证。本研究的目的是对犬的 AC-cTnI-HS 检测法进行分析验证，评估 AC-cTnI-HS 与之前的 ADVIA Centaur TnI-Ultra（AC-cTnI-U）检测法的相关性，评估 cTnI 样本储存稳定性，并在健康犬和患有心脏病的犬中临床评估 AC-cTnI-HS 检测法。使用犬血清样本进行分析验证。评估了批内和批间变异性、稀释平行性和加标回收率。评估了 196 只客户拥有的犬的样本（健康犬（n=39）或患有先天性心脏病的犬（n=54）、黏液样二尖瓣疾病（n=68）、扩张型心肌病（n=15）或心肌炎（n=20））。批内和批间变异系数（%CV）分别为 2.8-41.4%和 3.8-30.2%，浓度>20pg/mL 的所有样本的%CV<10%。稀释平行性和加标回收率实验的观察到的预期比值范围分别为 92.3-266.7.0%和 84.3-108%。AC-cTnI-HS 和 AC-cTnI-U 检测法之间存在很强的相关性（Spearman's ρ=0.927），但存在比例偏差，AC-cTnI-HS 检测法的浓度比例低于 AC-cTnI-U 检测法的浓度。储存在-80°C 下的血清样本可稳定保存长达 2.7 年，且在单个冻融循环后也可稳定保存。健康犬和患有先天性心脏病的犬的 cTnI 浓度明显低于其他三组犬的 cTnI 浓度。AC-cTnI-HS 检测法可精确、可重复、准确地测量犬血清中的 cTnI 浓度，其浓度>20pg/mL。
