Trueness Assessment for Serum Glucose Measurement Using Commercial Systems through the Preparation of Commutable Reference Materials
Annals of Laboratory Medicine
;
: 243-249, 2012.
Article
in English
| WPRIM
| ID: wpr-47756
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 enzymaticmethods:
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.
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Reagent Kits, Diagnostic
/
Reference Standards
/
Blood Chemical Analysis
/
Blood Glucose
/
Regression Analysis
/
Glucose Oxidase
/
Hexokinase
Type of study:
Diagnostic study
Limits:
Humans
Language:
English
Journal:
Annals of Laboratory Medicine
Year:
2012
Type:
Article
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