Defining analytical performance specifications: Consensus Statement from the 1st Strategic Conference of the European Federation of Clinical Chemistry and Laboratory Medicine

Quality and uncertainty requirements for reference materials and measurement procedures based on the ISO Guide 30-35 series and ISO 15194 and ISO 15193, respectively will be described. The impact of uncertainties related to values assigned to reference materials and reference measurement procedures and implications for the calibration / traceability chain will be addressed. The eventual need to reduce uncertainties based on clinical performance requirements should not lead to underestimation of uncertainty and omission of significant uncertainty components but rather to higher quality reference materials and measurement procedures as well as to adaptations of the calibration hierarchy in terms of reduction of the number of calibration steps and associated uncertainties.JRC.D.2-Standards for Innovation and sustainable Developmen