Abstract:
BACKGROUND:Hypercholesterolemia (plasma cholesterol concentration â¥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, 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 manufacturersâ 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 levels and can thus provide a cholesterol:HDL ratio. The Passing-Babloks 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 HDL 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.
journal_name
Ann Clin Biochemjournal_title
Annals of clinical biochemistryauthors
Kurstjens S,Gemen E,Walk S,Njo T,Krabbe J,Gijzen K,Elisen MGLM,Kusters Rdoi
10.1177/0004563221992393subject
Has Abstractpub_date
2021-01-21 00:00:00pages
4563221992393eissn
0004-5632issn
1758-1001pub_type
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journal_title:Annals of clinical biochemistry
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