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A comparison between alternative and trade name glucose test strips
M J Lenhard1, G S DeCherney, R E Maser
1Diabetes and Metabolic Diseases Center, Medical Center of Delaware, Wilmington 19806, USA.
Diabetes Care
|May 1, 1995
Summary
Alternative glucose test strips can predict blood glucose levels but are generally less accurate and precise than manufacturer-approved strips. This study evaluated seven alternative glucose test strips for reliability across three glucose meters.
Area of Science:
- Biomedical Engineering
- Clinical Chemistry
- Medical Device Evaluation
Background:
- Accurate blood glucose monitoring is crucial for diabetes management.
- The availability of alternative glucose test strips offers potential cost savings but raises questions about reliability.
- Evaluating the performance of these alternative strips against established methods is essential.
Purpose of the Study:
- To assess the reliability and accuracy of seven different alternative glucose test strips.
- To compare the performance of alternative test strips with manufacturer-approved (trade name) strips.
- To determine the accuracy of alternative glucose test strips across various blood glucose ranges and with different glucose meters.
Main Methods:
- Venous blood samples were collected from volunteers.
- Blood glucose levels were measured using laboratory analysis as a reference standard.
- Seven alternative glucose test strips were tested on three different glucose meters (One Touch II, Glucometer II, Glucometer III).
- Performance was evaluated using linear regression analysis and subgroup analysis based on glucose ranges.
Main Results:
- Linear regression analysis showed R2 values ranging from 0.84 to 0.97 when comparing test strips to plasma glucose values.
- Trade name strips and specific alternative strips (Quick Check, First Choice) demonstrated high accuracy and precision across all glucose ranges for certain meters.
- Alternative strips were generally less accurate than trade name strips, with one exception (First Choice for Glucometer II).
- All trade name test strips exhibited higher precision than the alternative strips.
Conclusions:
- Alternative glucose test strips can provide a prediction of laboratory blood glucose values.
- However, alternative glucose test strips are generally not as accurate or precise as the trade name test strips.
- The reliability of alternative glucose test strips varies depending on the specific strip, meter, and blood glucose range.