Analytical and Clinical Validation of a New Immunoenzymatic Method for the Measurement of Canine Parathyroid Hormone

SIMPLE SUMMARY: In dogs affected with chronic kidney disease (CKD), mineral disorders, including renal hyperparathyroidism (RHPT), are frequent. Secondary RHPT is the increase in serum parathyroid hormone (PTH), that can have a significant impact in the disease progression. Despite its clinical utility, the measurement of serum PTH is not routinely executed due to limited availability of validated methods. The aims of this study were: the analytical validation of a new method for PTH measurement in dogs and analysis of the preliminary association of the obtained results with the renal status. Twenty-seven samples obtained from dogs that were healthy or affected with CKD were analysed. PTH was measured using a commercially available human assay. The precision and accuracy of this method were assessed and the PTH stability at different temperatures was evaluated. Clinical validation was performed by comparing PTH values with clinicopathological parameters often altered during CKD, such as creatinine and phosphorus, and with the disease severity. The method showed an optimal precision and accuracy; the stability was compatible with the standard sample processing times. PTH was positively associated with creatinine and phosphorus. The investigated method was successfully validated in dogs, allowing its use for clinical purposes. ABSTRACT: 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.