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Analytic and clinical performance of two compact cholesterol-testing devices
D F Volles1, J M McKenney, W G Miller
1Department of Pharmacy and Pharmaceutics, Medical College of Virginia, Virginia Commonwealth University, Richmond, USA.
Pharmacotherapy
|February 20, 1998
Summary
Two compact cholesterol analyzers, AccuMeter and LDX, showed acceptable accuracy but failed precision standards set by the National Cholesterol Education Program (NCEP). Both devices had variability in results, with some exceeding error limits.
Area of Science:
- Clinical Chemistry
- Point-of-Care Testing
- Cardiovascular Risk Assessment
Background:
- Compact, affordable cholesterol analyzers are increasingly used outside traditional clinical laboratories.
- Accurate and precise cholesterol measurements are crucial for cardiovascular disease risk stratification.
Purpose of the Study:
- To evaluate the analytical and clinical performance of the AccuMeter and LDX total cholesterol analyzers.
- To compare device performance against National Cholesterol Education Program (NCEP) guidelines for accuracy and precision.
Main Methods:
- Accuracy was assessed using capillary and venous whole blood from 100 subjects, compared to a CDC standardized method.
- Precision was evaluated using three pooled serum samples assayed in duplicate over 20 days.
- Key metrics included mean percent bias, mean absolute percent bias, total error, and coefficient of variation (CV).
Main Results:
- Both devices demonstrated acceptable mean percent bias for total cholesterol, meeting NCEP +/- 3% requirements.
- However, both AccuMeter (5.3% CV) and LDX (4.0% CV) failed to meet the NCEP precision recommendation of 3% CV.
- A significant percentage of individual results from both devices exceeded the NCEP total error limit of +/- 8.9%.
Conclusions:
- While AccuMeter and LDX analyzers offer reasonable accuracy for cholesterol measurement, their precision is suboptimal according to NCEP standards.
- Variability in results may lead to excessive individual errors, though clinical misclassification rates for coronary heart disease risk remain relatively low.
- Further validation and potential improvements in precision are recommended for these point-of-care cholesterol testing devices.