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Technical evaluation of five glucose meters with data management capabilities
J J Chance1, D J Li, K A Jones
1Department of Pathology, Johns Hopkins Medical Institutions, Baltimore, Maryland, USA.
American Journal of Clinical Pathology
|April 7, 1999
Summary
Five glucose meters demonstrated equivalent technical performance for point-of-care testing. Selection should prioritize data management features, as all meters met accuracy and precision criteria for hospital use.
Area of Science:
- Clinical Chemistry
- Medical Devices
- Biotechnology
Background:
- Point-of-care glucose testing programs require reliable meters with robust data management.
- Technical performance and data handling are key selection criteria for these devices.
Purpose of the Study:
- To evaluate the technical performance of five commercially available glucose meters with data management capabilities.
- To compare their accuracy, precision, linearity, and potential biases against laboratory standards.
Main Methods:
- Comparative technical evaluation of five glucose meters against a reference laboratory method.
- Assessment of linearity using glucose-spiked venous specimens.
- Analysis of precision (within-day and between-day) and hematocrit/volume effects.
Main Results:
- All five meters exhibited technically equivalent performance.
- Linear regression slopes ranged from 0.94 to 1.02, correlating better with plasma than whole blood values.
- At least 90% of results were within +/- 15% of laboratory values; 75-87% were within +/- 10%.
- Within-day and between-day coefficients of variation were 2-5%.
- Linearity generally matched manufacturer specifications; negative bias observed with increasing hematocrit.
- No significant volume effects noted between 5-40 µL.
Conclusions:
- All evaluated glucose meters meet technical performance standards for hospital point-of-care testing.
- Institutional data management requirements are likely the primary differentiator for system selection.
- The meters show good precision and accuracy, though hematocrit can influence results.
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