COURSE NOTES Validation of GOD / PAP method for quantitative determination of glucose concentration in human serum Validarea metodei GOD / PAP pentru determinarea cantitativ a concentraiei de glucoz în ser

All accredited medical laboratories from Romania co mply with the requirements of SR EN ISO 15189:2007. These requirements include method validation. Medical laboratories use validated met hods taken from the literature but, before using it, each labo ratory has the responsibility to verify if the method performances are accomplished in a range of conditions whi ch are specific for that laboratory (personnel, equ ipment, reagents, reference material and control material). Method validation is a process by which every labor atory should check and establish the method's performance characteristics, but also the laboratory should id entify the influences which may change these characteristics a nd to what extent. In this study the authors descri bed the manner in which they documented and verified perfor mance parameters (precision and accuracy of measure ments, measurement uncertainty) in order to demonst rate that GOD / PAP method to measure serum glucose is fit for purpose in own laboratory conditions.