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Updated: Nov 20, 2025

Cholesterol Efflux Assay

Cholesterol Efflux Assay

Published on: March 6, 2012

Performance of commercially-available cholesterol self-tests.

Steef Kurstjens¹, Eugenie Gemen¹, Selina Walk¹

¹Laboratory of Clinical Chemistry and Hematology, Jeroen Bosch Hospital, Den Bosch, the Netherlands.

Annals of Clinical Biochemistry

|January 22, 2021

Summary

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Cholesterol self-tests vary in accuracy, with the Roche Accutrend Plus showing excellent performance. However, many commercially available tests do not meet required qualifications, necessitating better regulation for reliable cardiovascular disease risk assessment.

Area of Science:

Clinical Chemistry
Diagnostic Performance Evaluation
Medical Device Assessment

Background:

Hypercholesterolemia is a significant risk factor for cardiovascular disease and stroke.
Numerous cholesterol self-tests are accessible, but their analytical and diagnostic performance is not well-documented.
Accurate self-monitoring of cholesterol levels is crucial for managing cardiovascular health.

Purpose of the Study:

To evaluate the analytical and diagnostic performance of five different cholesterol self-tests.
To compare the accuracy of quantitative meters and semi-quantitative strip tests.
To determine if commercially available self-tests meet required performance standards.

Main Methods:

Sixty-two adult patients requiring lipid panel measurements were included.

Keywords:

Cholesterol analytical performance diagnostics lipids screening self-tests

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Five self-tests (three quantitative meters, two semi-quantitative strips) were assessed.

Performance was evaluated against manufacturers' protocols and standard lipid panel measurements.

Main Results:

The Roche Accutrend Plus demonstrated the best performance with a Mean Absolute Relative Difference (MARD) of 6±5%.
Other self-tests showed considerably poorer accuracy, with MARDs up to 20±12%.
The Accutrend Plus achieved 92% sensitivity and 89% specificity; some tests failed to accurately measure HDL or provide reliable cholesterol:HDL ratios.

Conclusions:

The Roche Accutrend Plus offers excellent diagnostic and analytic performance for cholesterol self-testing.
Several commercially available self-tests exhibit poor accuracy and do not meet required qualifications.
Improved regulation, standardization, and harmonization of cholesterol self-tests are essential for reliable patient results and cardiovascular risk management.