1. Indirect methods for reference interval determination - Review and recommendations
- Author
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Jones, Graham R. D., Haeckel, Rainer, Loh, Tze Ping, Sikaris, Ken, Streichert, Thomas, Katayev, Alex, Barth, Julian H, Bursa Uludağ Üniversitesi/Tıp Fakültesi/Biyokimya Anabilim Dalı., Özarda, Yeşim, and AAL-8873-2021
- Subjects
Paper ,Decision limits ,Cost ,Medical information ,Project ,Review ,Patient care ,Reference values ,Clinical chemistry ,Bhattacharya ,Clinical Chemistry ,Thyrotropin ,Chemical Species ,Humans ,Priority journal ,Risk assessment ,Individual biological variations ,Hospitalized population ,Statistical approach ,Indirect methods ,Reference intervals ,Methodology ,Standard ,Global multicenter ,Statistical analysis ,Determining reference limit ,Publication ,Reference standards ,Pathology testing ,Derivation ,Comparative study ,Medical laboratory technology ,Reference value ,Chemistry, clinical ,Human - Abstract
Reference intervals are a vital part of the information supplied by clinical laboratories to support interpretation of numerical pathology results such as are produced in clinical chemistry and hematology laboratories. The traditional method for establishing reference intervals, known as the direct approach, is based on collecting samples from members of a preselected reference population, making the measurements and then determining the intervals. An alternative approach is to perform analysis of results generated as part of routine pathology testing and using appropriate statistical techniques to determine reference intervals. This is known as the indirect approach. This paper from a working group of the International Federation of Clinical Chemistry (IFCC) Committee on Reference Intervals and Decision Limits (C-RIDL) aims to summarize current thinking on indirect approaches to reference intervals. The indirect approach has some major potential advantages compared with direct methods. The processes are faster, cheaper and do not involve patient inconvenience, discomfort or the risks associated with generating new patient health information. Indirect methods also use the same preanalytical and analytical techniques used for patient management and can provide very large numbers for assessment. Limitations to the indirect methods include possible effects of diseased subpopulations on the derived interval. The IFCC C-RIDL aims to encourage the use of indirect methods to establish and verify reference intervals, to promote publication of such intervals with clear explanation of the process used and also to support the development of improved statistical techniques for these studies.
- Published
- 2019