title: Common decision limits --The need for harmonised immunoassays.
abstract: The main aim of clinical guidelines is to encourage the best clinical outcome for patients and the best use of resources, no matter where patients are investigated or managed. Where guidelines incorporate decision limits based on levels of analytes in serum, plasma or urine these may determine whether or not to treat or may be used to tailor further treatment. Consideration should be given to the effect of method-related differences in results when implementing common decision limits. Available evidence suggests that for some analytes the implications for the patient may be serious, e.g. in terms of missed biopsies or unnecessary prostatic biopsies when prostate specific antigen is measured. Major causes of between-method differences are reviewed and means of addressing them considered.
authors.affiliation: UK NEQAS [Edinburgh], Department of Laboratory Medicine, Royal Infirmary of Edinburgh, Edinburgh EH16 4SA, UK. Electronic address: C.Sturgeon@ed.ac.uk.
authors.forename: Catharine M
authors.initials: CM
authors.lastname: Sturgeon
mesh_terms: D002138:Calibration; D019963:Clinical Chemistry Tests / Q000379:methods* / Q000592:standards*; D006801:Humans; D007118:Immunoassay / Q000379:methods* / Q000592:standards*; D038622:Internationality; D057230:Limit of Detection; D012015:Reference Standards
keywords: Clinical outcome; Decision limits; Method-related differences; Standardisation