title: Strategies and criteria for developing new urinalysis tests.
abstract: Urinalysis provides a non-invasive means to sequentially evaluate renal function and disease processes. Contemporary analytical techniques and the rapidly expanding knowledge of cell biology are yielding new ways of looking at urine constituents. Application of these new analytical techniques to screening, diagnosing and monitoring renal disease requires much more information than is currently available about the correlation of urine analytes with disease processes. Case definitions for specific renal disease depend upon a knowledge of natural history, response to therapy and laboratory data, including biopsy. When tests are being used to detect early stages of renal damage the subjects must be followed for months or years before a definitive diagnosis of irreversible disease can be established; therefore, prospective studies must be used to validate these tests. Analytes chosen for further study should be linked to significant renal pathophysiological processes. Gold standards for evaluating the predictive value of tests results must be established. The influence of renal disease on the analyte should be much greater than its biological variability under non-specific stresses. The results of using the test should benefit patients, taking into account the costs of false positive results and other costs to society that come from providing the test. Prospective studies needed to validate tests should be feasible and affordable. These studies could be facilitated by establishing a collaborative bank of urine samples linked to clinical data. Tests which are not used in clinical decision making are unimportant and of little value. Tests used in decision making should be evaluated as rigorously as the treatments that will be chosen based on the test results.
authors.affiliation: Department of Clinical Biochemistry, University of Toronto, Ontario, Canada.
authors.forename: A D
authors.initials: AD
authors.lastname: Baines
mesh_terms: D015415:Biomarkers / Q000652:urine; D003362:Cost-Benefit Analysis; D016002:Discriminant Analysis; D006801:Humans; D007674:Kidney Diseases / Q000175:diagnosis / Q000652:urine; D015203:Reproducibility of Results; D016482:Urinalysis / Q000191:economics / Q000379:methods* / Q000706:statistics & numerical data
chemical_list: D015415:Biomarkers