Article

Original Article

Ann Lab Med 2012; 32(4): 243-249

Published online July 1, 2012 https://doi.org/10.3343/alm.2012.32.4.243

Copyright © Korean Society for Laboratory Medicine.

Trueness Assessment for Serum Glucose Measurement Using Commercial Systems through the Preparation of Commutable Reference Materials

ChangYu Xia, M.S.1, Ou Liu, M.S.2, LanZhen Wang, Ph.D.3, and GuoBing Xu, M.S.1

Department of Clinical Laboratory1, Peking University First Hospital; Department of Clinical Laboratory2, First Hospital of Tsinghua University;
Reference Laboratory3, Beijing Leadman Biochemistry Co., Ltd, Beijing, China

Correspondence to: GuoBing Xu
Department of Clinical Laboratory, Peking University First Hospital, No. 8, Xishiku Street, Xi Cheng District, Beijing 100034, China
Tel: +86-10-83572042
Fax: +86-10-66551785
E-mail: xiachangyu@bjmu.edu.cn

Received: December 27, 2011; Revised: March 30, 2012; Accepted: May 18, 2012

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background: Commutable reference materials (RMs) are suitable for end-users for evaluating the metrological traceability of values obtained using routine measurement systems. We assessed the performance of 6 routine measurement systems with validated secondary RMs. Methods: We tested the homogeneity, stability, and commutability of 5 minimally processed human serum pools according to the standard guidelines. The serum pools were assigned values as per the reference procedure of the United States Centers for Disease Control and were used to evaluate the trueness of results from 6 commercial measurement systems based on enzymatic methods: 3 glucose oxidase (GOD) and 3 hexokinase (HK) methods. Results: The prepared RMs were validated to be sufficiently homogenous, stable, and commutable with the patient samples. Method bias varied for different systems: GOD01, -0.17 to 2.88%; GOD02, 1.66 to 4.58%; GOD03, -0.17 to 3.14%; HK01, -3.48 to -0.85%; HK02, -3.83 to -0.11%, and HK03, -1.82 to -0.27%. Conclusions: We observed that the prepared serum glucose RMs were qualified for trueness assessment. Most of the measurement systems met the minimal quality specifications.

Keywords: Glucose, Reference material, Commercial system, Bias