Are analytical performance specifications derived from reference intervals of any use in the veterinary clinical laboratory? A preliminary study on the empirical biological variation model.

Abstract

BACKGROUND: Analytical performance specifications (APS) are vital for method evaluation and quality control validation. However, the limited availability of biological variation (BV) data, regulatory guidelines, and expert opinion (EO) may present challenges in veterinary medicine. The empirical biological variation (EBV) approach, based on population reference intervals (pRI), has emerged as an alternative method to derive APS in human medicine. OBJECTIVES: This study aimed to assess the practicality and usefulness of the EBV approach in deriving performance limits for various measurands in dogs and cats. METHODS: Eight hematology and 13 biochemistry measurands were analyzed in dogs and cats. Estimates of combined biologic variation based on traditional biological (CV) and EBV-derived (CV*) formulas were calculated and assessed for evidence of correlation. Performance limits for expanded uncertainty/total error and imprecision were compared among EO, BV, and EBV. RESULTS: Strong and significant correlations were found between CVand CV* for both dogs (r&#x2009;=&#x2009;.86, p&#x2009;<&#x2009;.00001) and cats (r&#x2009;=&#x2009;0.95, p&#x2009;<&#x2009;.00001). The EBV-derived APS were generally comparable to EO and BV, with a subjective criterion of 1.5% difference for imprecision and 3% for total error/expanded uncertainty. CONCLUSION: The EBV approach, using pRI, shows promise as a surrogate marker for biological variation and as a practical tool for determining performance limits in dogs and cats. Assuming accurate pRI generated on analyzers with stable analytical performance, this approach could offer benefits when expert recommendations or robust BV studies are lacking or yield conflicting results. Further research is needed to explore the applicability and advantages of the EBV in veterinary medicine.