Shields E, Seiden-Long I, Massie S, Passante S, Leguillette R
University of Calgary Faculty of Veterinary Medicine (UCVM), 3330 Hospital Dr. NW, Calgary, T2N 4 N1, AB, Canada.
Foothills Medical Centre, University of Calgary Faculty of Medicine and Calgary Lab Services (CLS), Room C618B, 1403-29th St. NW, Calgary, T2N 2 T9, AB, Canada.
BMC Vet Res. 2016 Jun 13;12(1):104. doi: 10.1186/s12917-016-0737-1.
Cardiac troponin-I assays have been validated in horses.'High-sensitivity' cardiac troponin assays are now the standard in human cardiology.
Appropriately validate the'high-sensitivity' cardiac Troponin-T (hscTnT) assay for clinical use in horses, establish reference intervals, determine the biological variation, and demonstrate assay utility in selected clinical cases.
Analytical validation of the Roche hscTnT assay included within- and between-run precision, linear dose response, limit of quantitation (LoQ), stability, and comparison with cTn-I (iSTAT). Reference intervals and biological variation were determined using adult, healthy, Non-Competition Horses (N = 125) and Racing-Thoroughbreds (N = 178). HscTnT levels were measured in two horses with cardiac pathology.
The hscTnT demonstrates acceptable within-run (L1 = 6.5 ng/L, CV 14.9 %, L2 = 10.1 ng/L, CV 8.7 %, L3 = 15.3 ng/L, CV 5.4 %) and between-run precision (L1 = 12.2 ng/L, CV 8.4 %, L2 = 57.0 ng/L, CV 8.4 %, L3 = 256.0 ng/L, CV 9.0 %). The assay was linear from 3 to 391 ng/L. The LoQ was validated at 3 ng/L. Samples demonstrated insignificant decay over freeze-thaw cycle. Comparison with cTnI assay showed excellent correlation (range: 8.0-3535.0 ng/L, R(2) = 0.9996). Reference intervals: The upper 95(th) and 99(th) percentile of the hscTnT population distribution were 6.8 and 16.2 ng/L in Non-Competition Horses, and 14.0 and 23.2 ng/L in Racing-Thoroughbreds. Between-breed, diurnal effect, and between-day variation was below LoQ. Two clinical cases with presumed cardiac pathology had hscTnT levels of 220.9 ng/L and 5723.0 ng/L.
This benchmark study is the first to comply with CLSI guidelines, thus further establishing the performance characteristics of the hscTnT assay, and reference intervals in healthy horses. Two clinical cases demonstrated further the clinical utility of the assay.
心肌肌钙蛋白I检测已在马匹中得到验证。“高灵敏度”心肌肌钙蛋白检测现已成为人类心脏病学的标准。
对用于马匹临床的“高灵敏度”心肌肌钙蛋白T（hscTnT）检测进行适当验证，建立参考区间，确定生物学变异，并在选定的临床病例中证明该检测的实用性。
对罗氏hscTnT检测进行分析验证，包括批内和批间精密度、线性剂量反应、定量限（LoQ）、稳定性，并与cTn-I（iSTAT）进行比较。使用成年健康非竞赛马匹（N = 125）和竞赛纯种马（N = 178）确定参考区间和生物学变异。对两例患有心脏疾病的马匹测量hscTnT水平。
hscTnT检测显示出可接受的批内精密度（L1 = 6.5 ng/L，CV 14.9%，L2 = 10.1 ng/L，CV 8.7%，L3 = 15.3 ng/L，CV 5.4%）和批间精密度（L1 = 12.2 ng/L，CV 8.4%，L2 = 57.0 ng/L，CV 8.4%，L3 = 256.0 ng/L，CV 9.0%）。该检测在3至391 ng/L范围内呈线性。定量限验证为3 ng/L。样本在冻融循环中显示出无显著衰减。与cTnI检测的比较显示出极好的相关性（范围：8.0 - 3535.0 ng/L，R(2) = 0.9996）。参考区间：非竞赛马匹中hscTnT总体分布的第95和第99百分位数分别为6.8和16.2 ng/L，竞赛纯种马中分别为14.0和23.2 ng/L。品种间、昼夜效应和日间变异均低于定量限。两例疑似心脏疾病的临床病例hscTnT水平分别为220.9 ng/L和5723.0 ng/L。
这项基准研究首次符合CLSI指南，从而进一步确立了hscTnT检测的性能特征以及健康马匹的参考区间。两例临床病例进一步证明了该检测的临床实用性。
