Epidemiologic issues in the validation of veterinary diagnostic tests.

In this review, we critically discuss the objectives, methods and limitations of different approaches for the validation of diagnostic tests. We show (based on published data and our own experiences) that estimates for the diagnostic sensitivity and specificity may vary among populations and/or subpopulations of animals, conditional on the distribution of influential covariates. Additional variability in those parameter estimates may be attributable to the sampling strategy. The uncertainty about diagnostic parameters is of concern for the decision-maker in the context of clinical diagnosis or quantitative risk assessment as well as for the epidemiologist who uses test data for prevalence estimation or risk-factor studies. Examples for the calculation of diagnostic parameters are presented together with bias-avoidance strategies. We suggest guidelines for an epidemiologic approach to test validation of veterinary diagnostic tests.