Trueness assessment for serum glucose measurement using commercial systems through the preparation of commutable reference materials.
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.
Department of Clinical Laboratory, Peking University First Hospital, Beijing, China.
Changyu
C
Xia
Ou
O
Liu
Lanzhen
L
Wang
Guobing
G
Xu
D001774:Blood Chemical Analysis / Q000295:instrumentation / Q000592:standards*; D001786:Blood Glucose / Q000032:analysis*; D005949:Glucose Oxidase / Q000378:metabolism; D006593:Hexokinase / Q000378:metabolism; D006801:Humans; D011933:Reagent Kits, Diagnostic; D012015:Reference Standards; D012044:Regression Analysis
D001786:Blood Glucose; D011933:Reagent Kits, Diagnostic; D005949:Glucose Oxidase; D006593:Hexokinase