Performance of commercially-available cholesterol self-tests. (July 2021)

• Record Type: Journal Article
• Authors: Kurstjens, Steef; Gemen, Eugenie; Walk, Selina; Njo, Tjin; Krabbe, Johannes; Gijzen, Karlijn; Elisen, Marc GLM; Kusters, Ron
• Is Part Of: Annals of clinical biochemistry. Volume 58:Number 4(2021)
• Page Start: 289
• Page End: 296
• Publication Date: 2021-07
• Subjects: Cholesterol -- self-tests -- lipids -- analytical performance -- diagnostics -- screening; Clinical chemistry -- Periodicals; Clinical biochemistry -- Periodicals; 616.075
• DOI: 10.1177/0004563221992393
• Languages: English
• ISSNs: 0004-5632

Abstract

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.