S2E3 - How to establish and control the reference range of my assay?
Welcome to Ask Stago, The Podcast dedicated to provide expert answers to your expert questions in coagulation. In today episode, our expert Tara Simpson, will cover with us how to establish and control an assay reference range.
Literature sources:
- Henny J. Établissement et validation des intervalles de référence au laboratoire de biologie médicale. Ann Biol Clin 2011 ; 69(2) : 229-37 doi:10.1684/abc.2011.0537
- Gardiner, C, Coleman, R, de Maat, MPM, et al. International Council for Standardization in Haematology (ICSH) laboratory guidance for the evaluation of haemostasis analyser‐reagent test systems. Part 1: Instrument‐specific issues and commonly used coagulation screening tests. Int J Lab Hematol. 2020; 00: 1– 15. https://doi.org/10.1111/ijlh.13411
- CLSI. EP28-A3C Defining, Establishing and Verifying Reference Intervals in the Clinical Laboratory: Approved Guideline. 3rd ed. Wayne, PA: CLSI; 2008;28:1‐76
- Castellone DD. Establishing reference intervals in the coagulation laboratory. Int J Lab Hematol. 2017;39(Suppl 1):121-127
- CLSI. Measurement procedure comparison and Bias Estimation Using Patient samples. 3rd ed. CLSI guideline EP09c. Wayne PA: Clinical and Laboratory Standards Institute; 2018
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Content is scientific and technical in nature. It is intended as an educational tool for laboratory professionals and topics discussed are not intended as recommendations or as commentary on appropriate clinical practice.