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一种用于测量慢性肾病猫体内猫甲状旁腺激素的新型免疫酶法的分析验证

Analytical Validation of a New Immunoenzymatic Method for the Measurement of Feline Parathyroid Hormone in Cats with Chronic Kidney Disease.

作者信息

Zambarbieri Jari, Moretti Pierangelo, Giordano Alessia, Scarpa Paola

机构信息

Department of Veterinary Medicine, University of Milan, Via dell'Università 6, 16900 Lodi, Italy.

出版信息

Animals (Basel). 2021 Oct 29;11(11):3100. doi: 10.3390/ani11113100.

Abstract

The determination of parathyroid hormone (PTH) in cats could be of clinical utility in many metabolic disorders, such as renal diseases, hypercalcemia, or nutritional imbalances. However, the available methods for the measurement of feline PTH are limited, not widely available, and need radioimmunoassays. The aim of this study was to perform the analytical validation of a new immunoenzymatic method for the measurement of feline PTH. Thirty-eight cats affected with chronic kidney disease (CKD) were included. PTH was measured using a two-site immunoenzymatic method validated in humans and dogs (ST AIA-PACK Intact PTH, Tosoh Bioscience, Tessenderlo, Belgium). The analytical validation provided the evaluation of precision (intra-assay and inter-assay), accuracy (linearity under dilution (LUD) and spike recovery test (SRT)), and the storage stability of serum samples at 20 °C, 4 °C, and -20 °C. The method showed good precision (intra-assay CVs (coefficient of variations) 3.19-9.61%; inter-assay CVs 9.26-15.28%). In both the intra- and inter-assays, the highest imprecision was found with the low concentration pool (9.61% and 15.28%) and accuracy (LUD and SRT r = 0.99, < 0.001), while the stability was optimal up until 7 days at -20 °C (-7.7%). The method was successfully validated in cats, allowing its future use in diagnostic procedures.

摘要

测定猫体内的甲状旁腺激素(PTH)在许多代谢紊乱疾病中可能具有临床应用价值,如肾脏疾病、高钙血症或营养失衡。然而,现有的猫PTH检测方法有限,不易广泛获取,且需要放射免疫测定法。本研究的目的是对一种用于测定猫PTH的新型免疫酶法进行分析验证。纳入了38只患有慢性肾病(CKD)的猫。使用在人类和犬类中经验证的双位点免疫酶法(ST AIA-PACK全段甲状旁腺激素,日本东曹生物科学公司,比利时泰森德洛)测定PTH。分析验证包括评估精密度(批内和批间)、准确度(稀释线性度(LUD)和加标回收试验(SRT))以及血清样本在20℃、4℃和-20℃下的储存稳定性。该方法显示出良好的精密度(批内变异系数(CVs)为3.19 - 9.61%;批间CVs为9.26 - 15.28%)。在批内和批间分析中,低浓度样本池的不精密度最高(分别为9.61%和15.28%),准确度(LUD和SRT,r = 0.99,<0.001),而在-20℃下,样本稳定性在7天内最佳(-7.7%)。该方法在猫身上成功验证,使其未来可用于诊断程序。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/97b9/8614346/4ebf54f50649/animals-11-03100-g001.jpg

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