Winter Randolph L, Saunders Ashley B, Gordon Sonya G, Miller Matthew W, Sykes Katharine T, Suchodolski Jan S, Steiner Jörg M
Department of Small Animal Clinical Sciences, College of Veterinary Medicine and Biomedical Sciences, Texas A&M University, College Station, TX, USA.
Department of Small Animal Clinical Sciences, College of Veterinary Medicine and Biomedical Sciences, Texas A&M University, College Station, TX, USA.
J Vet Cardiol. 2014 Jun;16(2):81-9. doi: 10.1016/j.jvc.2014.03.002. Epub 2014 Apr 26.
To analytically validate a commercially available high-sensitivity immunoassay for measurement of cardiac troponin I (cTnI) in humans for use in dogs and to evaluate serum cTnI concentrations in healthy dogs and 3 well-defined groups of dogs with common cardiac diseases.
Canine serum samples were used for validation. 85 client-owned dogs including 24 healthy controls, 20 with myxomatous mitral valve disease, 19 with congenital heart disease, and 22 with arrhythmias.
Four serum samples were used to analytically validate the ADVIA Centaur TnI-Ultra assay by assessing intra-assay variability, inter-assay variability, spiking recovery, and dilutional parallelism. Dogs were grouped based on examination, echocardiography, and additional testing as clinically indicated, and serum cTnI concentrations were compared.
Analysis of the serum samples used for validation revealed an intra-assay coefficient of variation between 3.6% and 5.7%, and an inter-assay coefficient of variation between 2.4% and 5.9%. Observed to expected ratios for spiking recovery were 97.9 ± 8.6% (mean, SD). Observed to expected ratios for dilutional parallelism were 73.0 ± 11.5% (mean, SD). Dogs with cardiac disease had significantly higher serum cTnI concentrations (P < 0.005) than healthy dogs.
The ADVIA Centaur TnI-Ultra's low limit of detection allows measurement of serum cTnI in the majority of dogs even with no or mild cardiac disease. Dilution of samples for measurement of values above the upper limit of detection is not reliable and therefore not recommended. Serum cTnI concentrations are significantly higher in dogs with cardiac disease compared to healthy dogs.
分析验证一种市售的用于检测人心脏肌钙蛋白I（cTnI）的高灵敏度免疫测定法在犬类中的适用性，并评估健康犬以及患有常见心脏病的3组明确犬类群体的血清cTnI浓度。
犬血清样本用于验证。85只客户拥有的犬，包括24只健康对照犬、20只患有黏液瘤性二尖瓣疾病的犬、19只患有先天性心脏病的犬和22只患有心律失常的犬。
使用4份血清样本通过评估批内变异性、批间变异性、加标回收率和稀释平行性来分析验证ADVIA Centaur TnI-Ultra测定法。根据检查、超声心动图和临床指示的其他检测对犬进行分组，并比较血清cTnI浓度。
用于验证的血清样本分析显示批内变异系数在3.6%至5.7%之间，批间变异系数在2.4%至5.9%之间。加标回收率的观察值与预期值之比为97.9±8.6%（平均值，标准差）。稀释平行性的观察值与预期值之比为73.0±11.5%（平均值，标准差）。患有心脏病的犬血清cTnI浓度显著高于健康犬（P<0.005）。
ADVIA Centaur TnI-Ultra的低检测限使得即使在没有心脏病或患有轻度心脏病的大多数犬中也能测量血清cTnI。对于检测值高于检测上限的样本进行稀释测量不可靠，因此不建议使用。与健康犬相比，患有心脏病的犬血清cTnI浓度显著更高。
