Sikaris, Ken AndrewStreichert, ThomasMacri, Joseph2022-12-212022-12-212018-05-18Özarda, Y. vd. (2018). ''Distinguishing reference intervals and clinical decision limits – A review by the IFCC committee on reference intervals and decision limits''. Critical Reviews in Clinical Laboratory Sciences, 55(6), 420-431.1040-83631549-781Xhttps://doi.org/10.1080/10408363.2018.1482256https://www.tandfonline.com/doi/full/10.1080/10408363.2018.1482256http://hdl.handle.net/11452/30010Reference Intervals (RIs) and clinical decision limits (CDLs) are a vital part of the information supplied by laboratories to support the interpretation of numerical clinical pathology results. RIs describe the typical distribution of results seen in a healthy reference population while CDLs are associated with a significantly higher risk of adverse clinical outcomes or are diagnostic for the presence of a specific disease. However, as the two concepts are sometimes confused, there is a need to clarify the differences between these terms and to ensure they are easily distinguished, especially because CDLs have a clinical association with specific diseases and risks, thereby implying that effective clinical interventions are available. It is important to note that, because population-based RIs are derived from the range of values expected in a typical community population, laboratory results that fall outside a RI do not necessarily indicate a disease but rather that additional medical follow-up and/or treatment may be warranted. In contrast, CDLs are associated with a risk of specific adverse outcomes, and are commonly used to interpret laboratory test results, including lipid parameters, glucose, hemoglobin A1c (HbA1c), and tumor markers, to determine risk of disease, to diagnose or to treat. In recent years, the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Committee on Reference Intervals and Decision Limits (C-RIDL) has focused primarily on RIs and has performed multicenter studies to obtain common RIs. However, the broader responsibility of the Committee, from its name, includes decision limits. C-RIDL now aims to emphasize the importance of the correct use of both RIs and CDLs and to encourage laboratories to specify the appropriate information to clinicians as needed. This review discusses RIs and CDLs in detail, describes the similarities and the differences between these two important tools in laboratory medicine, and clearly explains the processes used to define them. C-RIDL encourages the involvement of laboratory professionals in the establishment of both RIs and CDLs.eninfo:eu-repo/semantics/closedAccessReference intervalsClinical decision limitsC-RIDLClinical laboratoriesProstate-specific antigenEuropean atherosclerosis societyPrediatric peference intervalsApproved recommendation1987Joint consensus statementHigh-density-lipoproteinReference values99th percentileAnalytical performanceGlobal multicenterMedical laboratory technologyClinical laboratory techniquesHumansLaboratoriesReference valuesReview0004407015000032-s2.0-8505107716242043155630047297Medical laboratory technologyClinical Chemistry; Thyrotropin; Chemical SpeciesGlucoseHemoglobin A1cLipidClinical decision limitClinical decision makingHealth care organizationHumanLaboratory testPriority journalReference valueReviewLaboratoryLaboratory techniqueOrganization and managementStandards