RRML - Validation of GOD / PAP method for quantitative determination of glucose concentration in human serum

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Nr. 19(1)/2011

Validation of GOD / PAP method for quantitative determination of glucose concentration in human serum

Irina L Dumitriu, Bogdan Gurzu, Elena Cojocaru, Simona M. Slătineanu, Maria Enea

Abstract:

All accredited medical laboratories from Romania comply with the requirements of SR EN ISO 15189:2007. These requirements include method validation. Medical laboratories use validated methods taken from the literature but, before using it, each laboratory has the responsibility to verify if the method performances are accomplished in a range of conditions which are specific for that laboratory (personnel, equipment, reagents, reference material and control material). Method validation is a process by which every laboratory should check and establish the method's performance characteristics, but also the laboratory should identify the influences which may change these characteristics and to what extent. In this study the authors described the manner in which they documented and verified performance parameters (precision and accuracy of measurements, measurement uncertainty) in order to demonstrate that GOD / PAP method to measure serum glucose is fit for purpose in own laboratory conditions.

Keywords: method validation,precision,accuracy,measurement uncertainty

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Dumitriu IL, Gurzu B, Cojocaru E, Slătineanu SM, Enea M. Validation of GOD / PAP method for quantitative determination of glucose concentration in human serum. Rev Romana Med Lab. 2011;19(1):85-100