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Distinguishing reference intervals and clinical decision limits – A review by the IFCC committee on reference intervals and decision limits
- Publication Year :
- 2018
- Publisher :
- Taylor and Francis, 2018.
-
Abstract
- Reference 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.
- Subjects :
- Laboratory test
Standards
Clinical decision limits
Review
Reference values
Laboratory
Health care organization
Joint consensus statement
Laboratory technique
Organization and management
Clinical Chemistry
Thyrotropin
Chemical Species
Humans
High-density-lipoprotein
C-RIDL
Priority journal
Prediatric peference intervals
Reference intervals
Analytical performance
Lipid
European atherosclerosis society
Clinical laboratories
Prostate-specific antigen
Global multicenter
Glucose
Hemoglobin A1c
Clinical laboratory techniques
99th percentile
Medical laboratory technology
Laboratories
Approved recommendation1987
Clinical decision making
Reference value
Clinical decision limit
Human
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Accession number :
- edsair.od......9458..422ceb8f6b82a7f9974b6b88b41a037c