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http://hdl.handle.net/11452/33044
Title: | Verification of reference intervals in routine clinical laboratories: Practical challenges and recommendations |
Authors: | Higgins, Victoria Adeli, Khosrow Bursa Uludağ Üniversitesi/Tıp Fakültesi/Temel Tıp Bilimleri Bölümü. Özarda, Yeşim AAL-8873-2021 35741320500 |
Keywords: | Medical laboratory technology Clinical laboratories CLSI EP28-A3c guideline Data mining Reference intervals Verification Pediatric reference intervals Geriatric ages establishment Adult reference intervals Special chemistry biomarkers Reference values Worldwide multicenter Biochemical markers Global multicenter Caliper database Healthy |
Issue Date: | Jan-2019 |
Publisher: | Walter de Gruyter |
Citation: | Özarda, Y. vd. (2019). ''Verification of reference intervals in routine clinical laboratories: Practical challenges and recommendations''. Clinical Chemistry and Laboratory Medicine, 57(1), Special Issue, 30-37. |
Abstract: | Reference intervals (RIs) are fundamental tools used by healthcare and laboratory professionals to interpret patient laboratory test results, ideally enabling differentiation of healthy and unhealthy individuals. Under optimal conditions, a laboratory should perform its own RI study to establish RIs specific for its method and local population. However, the process of developing RIs is often beyond the capabilities of an individual laboratory due to the complex, expensive and time-consuming process to develop them. Therefore, a laboratory can alternatively verify RIs established by an external source. Common RIs can be established by large, multicenter studies and can subsequently be received by local laboratories using various verification procedures. The standard approach to verify RIs recommended by the Clinical Laboratory Standards Institute (CLSI) EP28-A3c guideline for routine clinical laboratories is to collect and analyze a minimum of 20 samples from healthy subjects from the local population. Alternatively, "data mining" techniques using large amounts of patient test results can be used to verify RIs, considering both the laboratory method and local population. Although procedures for verifying RIs in the literature and guidelines are clear in theory, gaps remain for the implementation of these procedures in routine clinical laboratories. Pediatric and geriatric age-groups also continue to pose additional challenges in respect of acquiring and verifying RIs. In this article, we review the current guidelines/approaches and challenges to RI verification and provide a practical guide for routine implementation in clinical laboratories. |
URI: | https://doi.org/10.1515/cclm-2018-0059 https://www.degruyter.com/document/doi/10.1515/cclm-2018-0059/html http://hdl.handle.net/11452/33044 |
ISSN: | 1434-6621 1437-4331 |
Appears in Collections: | Scopus Web of Science |
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