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

SIMPLE SUMMARY: Parathyroid hormone (PTH) is involved in many metabolic diseases, such as chronic kidney disease (CKD) and calcium disorders, and its measurement could be of clinical utility. However, available methods for the measurement of feline PTH are limited and not widely accessible. The aim of this study was to perform the analytical validation of a new method for PTH measurement in cats. Thirty-eight cats affected with CKD were included. The analytical protocol provided an evaluation of the precision, accuracy, and storage stability at different temperatures. The method investigated showed good precision and accuracy and good stability for 1 week of storage at freezing temperatures. The method was validated in cats, allowing its future use in diagnostic procedures. 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(2) = 0.99, p < 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.