Zambarbieri Jari, Tagliasacchi Filippo, Moretti Pierangelo, Giordano Alessia, Scarpa Paola
Department of Veterinary Medicine, University of Milan, Via dell'Università 6, 26900 Lodi, Italy.
Animals (Basel). 2020 Dec 17;10(12):2411. doi: 10.3390/ani10122411.
Renal hyperparathyroidism (RHPT) is one of the main complications in dogs affected with Chronic Kidney Disease (CKD). The measurement of serum parathyroid hormone (PTH) could be of clinical utility for the disease's treatment and follow-up; however, PTH is not routinely determined due to limited available methods, often not fully validated in dogs. The aims of this study were the analytical validation of an immunoenzymatic method for the measurement of PTH in canine serum and the analysis of preliminary association of the obtained results with renal function. Twenty-six samples obtained from dogs healthy or affected with CKD were analysed. PTH was measured using a two-site immunoenzymometric human assay (ST AIA-PACK Intact PTH, Tosoh Bioscience). The analytical validation protocol evaluated the assay precision and accuracy. Also, the PTH's storage stability at 20 °C, 4 °C and -20 °C was assessed. Clinical validation was performed by comparing PTH values with creatinine, phosphorus and International Renal Interest Society (IRIS) stage. The method showed optimal precision and accuracy, whereas stability was adequate up to 4 h at 20 °C, 24 h at 4 °C and 6 months at -20 °C. PTH was positively associated with creatinine, phosphorus and IRIS stage. The investigated method was thus successfully validated in dogs, allowing its use for clinical purpose.
肾性甲状旁腺功能亢进（RHPT）是患有慢性肾脏病（CKD）犬类的主要并发症之一。血清甲状旁腺激素（PTH）的检测对于该疾病的治疗和随访可能具有临床实用性；然而，由于可用方法有限，且这些方法在犬类中往往未得到充分验证，PTH并非常规检测项目。本研究的目的是对一种用于检测犬血清中PTH的免疫酶法进行分析验证，并分析所得结果与肾功能的初步相关性。对26份来自健康犬或患有CKD犬的样本进行了分析。使用双位点免疫酶法（ST AIA-PACK完整PTH，东曹生物科学公司）检测PTH。分析验证方案评估了该检测方法的精密度和准确性。此外，还评估了PTH在20℃、4℃和-20℃下的储存稳定性。通过将PTH值与肌酐、磷和国际肾脏兴趣协会（IRIS）分期进行比较来进行临床验证。该方法显示出最佳的精密度和准确性，而在20℃下稳定性可达4小时，4℃下可达24小时，-20℃下可达6个月。PTH与肌酐、磷和IRIS分期呈正相关。因此，所研究的方法在犬类中成功得到验证，可用于临床目的。
