Performance of commercially-available cholesterol self-tests

Background Hypercholesterolemia (plasma cholesterol concentration >= 5.2 mmol/L) is a risk factor for cardiovascular disease and stroke. Many different cholesterol self-tests are readily available at general stores, pharmacies and web shops. However, there is limited information on their analytical and diagnostic performance. Methods We included 62 adult patients who required a lipid panel measurement (cholesterol, high-density lipoprotein (HDL), triglycerides and LDLcalc) for routine care. The performance of five different cholesterol self-tests, three quantitative meters (Roche Accutrend Plus, Mission 3-in-1 and Qucare) and two semi-quantitative strip tests (Veroval and Mylan MyTest), was assessed according to the manufacturers' protocol. Results The average plasma cholesterol concentration was 5.2 +/- 1.2 mmol/L. The mean absolute relative difference (MARD) of the five cholesterol self-tests ranged from 6 +/- 5% (Accutrend Plus) to 20 +/- 12% (Mylan Mytest). The Accutrend Plus cholesterol meter showed the best diagnostic performance with a 92% sensitivity and 89% specificity. The Qucare and Mission 3-in-1 are able to measure HDL concentrations and can thus provide a cholesterol:HDL ratio. The Passing-Bablok regression analyses for the ratio showed poor performance in both self-tests (Mission 3-in-1: y = 1.62x-1.20; Qucare: y = 0.61x + 1.75). The Accutrend Plus is unable to measure the plasma high-density lipoprotein concentration. Conclusions/interpretation: The Accutrend Plus cholesterol meter (Roche) had excellent diagnostic and analytic performance. However, several of the commercially-available self-tests had considerably poor accuracy and diagnostic performance and therefore do not meet the required qualifications, potentially leading to erroneous results. Better regulation, standardization and harmonization of cholesterol self-tests is warranted.

Automated summary

The study found varying levels of analytical and diagnostic performance among different cholesterol self-tests, with Roche's Accutrend Plus cholesterol meter showing the best results. Other self-tests displayed poor accuracy and diagnostic performance, highlighting the need for improved regulation and standardization.