The increasing number of biomarkers in farm animal production makes the establishment of analytical and clinical performance necessary before being accepted into routine clinical use. Into this context, three steps have been defined: phase I trials, that denote studies of the analytical precision, accuracy, sensitivity and specificity of a specific laboratory test; phase II trials, that refer to determining the usual range of results in healthy animals; and Phase III trials, which evaluate the ability of the test to answer a specific clinical question in context.
The establishment of reference normal range values could be considered as the first step in biomarker application once an analytical validation has been established. To establish reference range of values for a biomarker, a large population of healthy animals should be involved. However, there are some factors that should be taken into account such as sex, age, breed, herd, health status of the farm, and management conditions. Moreover, in the current moment, alternative non-invasive body fluids are in increasing demand, such as saliva, faeces, urine or tears, and several additional factors could be of interest for the establishment of reference values in these fluids such as degree of hydration, possible external contaminations or total protein content.
Not all biomarkers would be equally influenced by those factors, however this information is of great value for clinical application purposes. Thus the purpose of this Research Topic is to elucidate the main physiological and external factors and their influence that have to be taken into account prior the establishment of global reference range values in farm animal biomarkers.
The increasing number of biomarkers in farm animal production makes the establishment of analytical and clinical performance necessary before being accepted into routine clinical use. Into this context, three steps have been defined: phase I trials, that denote studies of the analytical precision, accuracy, sensitivity and specificity of a specific laboratory test; phase II trials, that refer to determining the usual range of results in healthy animals; and Phase III trials, which evaluate the ability of the test to answer a specific clinical question in context.
The establishment of reference normal range values could be considered as the first step in biomarker application once an analytical validation has been established. To establish reference range of values for a biomarker, a large population of healthy animals should be involved. However, there are some factors that should be taken into account such as sex, age, breed, herd, health status of the farm, and management conditions. Moreover, in the current moment, alternative non-invasive body fluids are in increasing demand, such as saliva, faeces, urine or tears, and several additional factors could be of interest for the establishment of reference values in these fluids such as degree of hydration, possible external contaminations or total protein content.
Not all biomarkers would be equally influenced by those factors, however this information is of great value for clinical application purposes. Thus the purpose of this Research Topic is to elucidate the main physiological and external factors and their influence that have to be taken into account prior the establishment of global reference range values in farm animal biomarkers.
