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, 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 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.

背景：高胆固醇血症（血浆胆固醇浓度≥5.2 mmol/L）是心血管疾病和中风的危险因素。许多不同的胆固醇自检可在一般商店、药房和网上商店轻松获得。然而，关于它们的分析和诊断性能的信息有限。

方法：我们纳入了 62 名需要进行血脂检测（胆固醇、HDL、甘油三酯和 LDLcalc）进行常规护理的成年患者。五种不同的胆固醇自测、三种定量计（Roche Accutrend Plus、Mission 3-in-1 和 Qucare）和两种半定量试纸测试（Veroval 和 Mylan MyTest）的性能，根据制造商的标准进行评估。 ? 协议。

结果：平均血浆胆固醇浓度为 5.2 ± 1.2 mmol/L。五项胆固醇自测的平均绝对相对差异 (MARD) 范围从 6 ± 5% (Accutrend Plus) 到 20 ± 12% (Mylan Mytest)。Accutrend Plus 胆固醇测量仪显示出最佳诊断性能，灵敏度为 92%，特异性为 89%。Qucare 和 Mission 3 合 1 能够测量 HDL 水平，因此可以提供胆固醇：HDL 比率。该比率的 Passing-Babloks 回归分析显示，在两个自测中的表现都很差（三合一任务：y = 1.62x - 1.20；Qucare：y = 0.61x + 1.75）。Accutrend Plus 无法测量血浆 HDL 浓度。

结论/解释： Accutrend Plus 胆固醇测量仪 (Roche) 具有出色的诊断和分析性能。然而，一些市售自检的准确性和诊断性能相当差，因此不符合要求的资格，可能导致错误的结果。有必要对胆固醇自检进行更好的监管、标准化和协调。