Peterson Mark E, Rishniw Mark, Bilbrough Graham E, Cote Kate B
1 Animal Endocrine Clinic, New York, NY, USA.
2 Cornell University, Ithaca, NY, USA.
J Feline Med Surg. 2018 Apr;20(4):319-324. doi: 10.1177/1098612X17708918. Epub 2017 May 12.
Objectives The Catalyst One Chemistry Analyzer (IDEXX Laboratories) is a point-of-care instrument that can measure total thyroxine (TT4) by immunoassay. The aims of this study were to evaluate the analytic performance of the Catalyst TT4 assay in feline sera and to examine agreement of the Catalyst TT4 results with those measured by immunoassay at a veterinary reference laboratory. Methods Assay precision, reproducibility and linearity were evaluated for the Catalyst TT4 assay. For method comparison, TT4 concentrations in serum samples from 157 cats (127 hyperthyroid, 30 radioiodine-treated cats) were analyzed by both in-clinic and reference laboratory methods. Results The Catalyst TT4 demonstrated good precision and reproducibility (coefficients of variation ⩽8.5%) and excellent linearity in the diagnostic range of 6-150 nmol/l. Differences between the two TT4 methods showed no proportional or fixed bias (Bland-Altman plots) but did demonstrate greater spread of values at higher TT4 concentrations. Statistical analysis of percent differences between methods indicated 95% limits of agreement of ± 30%. When serum TT4 concentrations were classified as low, high or within the reference interval (12-50 nmol/l) for each assay, there was strong agreement (96.8%) in classification between methods. Conclusions and relevance The Catalyst TT4 assay provided precise serum TT4 concentrations in the 157 samples analyzed, which agreed well with results provided by a reference laboratory. Cats with Catalyst TT4 concentrations near decision thresholds (eg, normal vs high) should either have TT4 concentration repeated a few weeks later and/or undergo further testing (eg, free T4, serum thyroid-stimulating hormone, thyroid scintigraphy) to determine thyroid status.
目的 催化物一号化学分析仪(IDEXX实验室)是一种即时检测仪器,可通过免疫测定法测量总甲状腺素(TT4)。本研究的目的是评估催化物TT4检测法在猫血清中的分析性能,并检验催化物TT4检测结果与兽医参考实验室通过免疫测定法测得的结果之间的一致性。方法 对催化物TT4检测法的精密度、重复性和线性进行评估。为进行方法比较,采用临床检测法和参考实验室检测法对157只猫(127只甲状腺功能亢进猫、30只接受放射性碘治疗的猫)血清样本中的TT4浓度进行分析。结果 催化物TT4检测法在6 - 150 nmol/l的诊断范围内显示出良好的精密度和重复性(变异系数≤8.5%)以及出色的线性。两种TT4检测方法之间的差异未显示出比例偏差或固定偏差(布兰德-奥特曼图),但在较高TT4浓度时确实显示出值的离散度更大。对方法间百分比差异的统计分析表明,一致性界限为±30%。当将每种检测方法的血清TT4浓度分为低、高或在参考区间(12 - 50 nmol/l)内时,两种方法在分类上有很强的一致性(96.8%)。结论及意义 在分析的157个样本中,催化物TT4检测法提供了精确的血清TT4浓度,与参考实验室提供的结果高度一致。催化物TT4浓度接近判定阈值(如正常与高值)的猫,应在几周后重复检测TT4浓度和/或进行进一步检测(如游离T4、血清促甲状腺激素、甲状腺闪烁显像)以确定甲状腺状态。