Rubén Gomez-Rioja, Alexander Von Meyer, Michael Cornes, Sean Costelloe, Pieter Vermeersch, Ana-Maria Simundic, Mads Nybo, Geoffrey Stuart Baird, Gunn B B Kristensen, Janne Cadamuro
OBJECTIVES: Knowledge of the stability of analytes in clinical specimens is a prerequisite for proper transport and preservation of samples to avoid laboratory errors. The new version of ISO 15189:2022 and the European directive 2017/746 increase the requirements on this topic for manufacturers and laboratories. Within the project to generate a stability database of European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group Preanalytical Phase (WG-PRE), the need to standardise and improve the quality of published stability studies has been detected, being a manifest deficit the absence of international guidelines for the performance of stability studies on clinical specimens...
April 6, 2023: Clinical Chemistry and Laboratory Medicine: CCLM