Validated reference values and procedures are needed to ensure optimal diagnosis of dyslipidemia in sub-Saharan Africa. We aimed to validate an analysis method and establish reference intervals of lipid profile parameters in Cameroonians using this method. On a cross-sectional study conducted from November 2019 to August 2020 in Yaoundé, we have analyzed blood samples with Cobas® 6000. We subscribed to ASQUALAB's External Quality Assessments (EQA) and Outsourced Internal Quality Controls (IQC). Reproducibility, repeatability, correctness accuracy and uncertainty were evaluated using IQC. Consenting adult participants were conveniently sampled, excluding those with any condition that may affect lipid profile. Descriptive statistics were reported accordingly, agreement was assessed with Bland–Altman analysis, and reference intervals were defined according to CLSI and IFCC recommendations. The coefficients of variation for repeatability, reproducibility, and correctness bias ranged between 0.6% and 6%, with all values within the normal range. Expanded uncertainty of total cholesterol, HDL and triglycerides measurements were, respectively, 0.45, 0.24 and 0.18. We included 422 participants with a mean age of 30.2 (10.9) years and 248 (58.8%) females. Reference intervals for total cholesterol, HDL, triglycerides and LDL were, respectively, 2.94–6.02 mmol/L, 0.90–2.06 mmol/L, 0.35–1.36 mmol/L, 1.37–4.13 mmol/L. These intervals were similar between sex and ethnic groups, but lower in younger participants. Lipid profile measurement with Cobas® 6000 is a reliable and accurate analysis in our context. Specific reference intervals must be used in African population, with further studies need for different age subgroups.

中文翻译：

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在撒哈拉以南非洲人群中验证血脂测量方法和建立参考值

需要经过验证的参考值和程序来确保对撒哈拉以南非洲地区血脂异常的最佳诊断。我们旨在验证一种分析方法，并使用该方法建立喀麦隆人血脂参数的参考区间。在 2019 年 11 月至 2020 年 8 月在雅温得进行的一项横断面研究中，我们使用 Cobas® 6000 分析了血液样本。我们订阅了 ASQUALAB 的外部质量评估 (EQA) 和外包内部质量控制 (IQC)。使用 IQC 评估再现性、重复性、正确性和不确定性。同意的成年参与者被方便地取样，不包括那些有任何可能影响血脂状况的人。相应地报告了描述性统计数据，通过 Bland-Altman 分析评估了一致性，参考区间是根据 CLSI 和 IFCC 建议定义的。重复性、再现性和正确性偏差的变异系数在 0.6% 和 6% 之间，所有值都在正常范围内。总胆固醇、HDL 和甘油三酯测量的扩展不确定度分别为 0.45、0.24 和 0.18。我们纳入了 422 名参与者，平均年龄为 30.2 (10.9) 岁，女性为 248 名 (58.8%)。总胆固醇、HDL、甘油三酯和 LDL 的参考区间分别为 2.94-6.02 mmol/L、0.90-2.06 mmol/L、0.35-1.36 mmol/L、1.37-4.13 mmol/L。这些间隔在性别和种族之间相似，但在年轻参与者中较低。在我们的背景下，使用 Cobas® 6000 进行脂质分布测量是一种可靠且准确的分析。