Estimating measurement uncertainty in the medical laboratory

Show simple item record

dc.contributor.advisor Newman, Jeffrey D.
dc.contributor.advisor Gomes, Maria Adelina Placido, Rui 2017-01-12T09:49:05Z 2017-01-12T09:49:05Z 2016-09
dc.description.abstract Medical Laboratories Accreditation is covered by ISO 15189:2012 - Medical Laboratories — Requirements for Quality and Competence. In Portugal, accreditation processes are held under the auspices of the Portuguese Accreditation Institute (IPAC), which applies the Portuguese edition (NP EN ISO 15189:2014). Accordingly, Medical Laboratories accreditation processes now require the estimate of measurement uncertainty (MU) associated to the results. The Guide to the Expression of Uncertainty in Measurement (GUM) describes the calculation of MU, not contemplating the specific aspects of medical laboratory testing. Several models have been advocated, yet without a final consensus. Given the lack of studies on MU in Portugal, especially on its application in the medical laboratory, it is the objective of this thesis to reach to a model that fulfils the IPAC’s accreditation regulations, in regards to this specific requirement. The study was based on the implementation of two formulae (MU-A and MU-B), using the Quality Management System (QMS) data of an ISO 15189 Accredited Laboratory. Including the laboratory’s two Cobas® 6000–c501 (Roche®) analysers (C1 and C2) the work focused three analytes: creatinine, glucose and total cholesterol. The MU-B model formula, combining the standard uncertainties of the method’s imprecision, of the calibrator’s assigned value and from the pre-analytical variation, was considered the one best fitting to the laboratory's objectives and to the study's purposes, representing well the dispersion of values reasonably attributable to the measurand final result. Expanded Uncertainties were: Creatinine - C1 = 9,60%; C2 = 5,80%; Glucose - C1 = 8,32%; C2 = 8,34%; Cholesterol - C1 = 4,00%; C2 = 3,54 %. ...[cont.]. en_UK
dc.language.iso en en_UK
dc.publisher Cranfield University en_UK
dc.rights © Cranfield University, 2016. All rights reserved. No part of this publication may be reproduced without the written permission of the copyright holder. en_UK
dc.subject Accreditation en_UK
dc.subject ISO15189 Standard en_UK
dc.subject Technical Requirement en_UK
dc.subject Top-Down en_UK
dc.subject Calibration Hierarchy en_UK
dc.subject Traceability en_UK
dc.subject Trueness en_UK
dc.subject Bias en_UK
dc.subject Intermediate Precision en_UK
dc.subject Imprecision en_UK
dc.subject Pre-analytical Phase en_UK
dc.subject Variation en_UK
dc.title Estimating measurement uncertainty in the medical laboratory en_UK
dc.type Thesis or dissertation en_UK
dc.type.qualificationlevel Doctoral en_UK
dc.type.qualificationname PhD en_UK

Files in this item

This item appears in the following Collection(s)

Show simple item record

Search CERES


My Account