Laboratory of Clinical Chemistry and Hematology, Jeroen Bosch Hospital, Den Bosch, the Netherlands.
Laboratory of Clinical Chemistry, Saltro, Utrecht, the Netherlands.
Ann Clin Biochem. 2021 Jul;58(4):289-296. doi: 10.1177/0004563221992393. Epub 2021 Feb 17.
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.
We included 62 adult patients who required a lipid panel measurement (cholesterol, high-density lipoprotein (HDL), triglycerides and LDL) for routine care. The performance of five different cholesterol self-tests, three quantitative meters (, and ) and two semi-quantitative strip tests ( and ), was assessed according to the manufacturers' protocol.
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% () to 20 ± 12% (). The cholesterol meter showed the best diagnostic performance with a 92% sensitivity and 89% specificity. The and 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 (: y = 1.62x-1.20; : y = 0.61x + 1.75). The is unable to measure the plasma high-density lipoprotein concentration.Conclusions/interpretation: The 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.
高胆固醇血症（血浆胆固醇浓度≥5.2mmol/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试剂盒在杂货店、药店和网店都很容易买到。然而，关于它们的分析和诊断性能的信息有限。
我们纳入了 62 名需要血脂检测（胆固醇、高密度脂蛋白（HDL）、甘油三酯和 LDL）的成年患者。根据制造商的方案，评估了五种不同的胆固醇自检试剂盒、三种定量仪器（、和）和两种半定量条带测试（和）的性能。
平均血浆胆固醇浓度为 5.2±1.2mmol/L。五种胆固醇自检试剂盒的平均绝对相对差异（MARD）范围为 6±5%（）至 20±12%（）。胆固醇仪的诊断性能最佳，灵敏度为 92%，特异性为 89%。和能够测量 HDL 浓度，因此可以提供胆固醇：HDL 比值。Passing-Bablok 回归分析表明这两种自检试剂盒的比值表现均不佳（：y=1.62x-1.20；：y=0.61x+1.75）。不能测量血浆高密度脂蛋白浓度。
结论/解释：罗氏胆固醇仪（Roche）具有出色的诊断和分析性能。然而，一些市售的自检试剂盒准确性和诊断性能较差，因此不符合要求，可能导致错误的结果。需要更好地监管、标准化和协调胆固醇自检试剂盒。
