Real-world impact of transitioning from one lipoprotein(a) assay to another in a clinical setting

IF 4.3 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS American journal of preventive cardiology Pub Date : 2024-09-01 DOI:10.1016/j.ajpc.2024.100726

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Abstract

Background and aims

Different lipoprotein(a) [Lp(a)] assays may affect risk stratification of individuals and thus clinical decision-making. We aimed to investigate how transitioning between Lp(a) assays at a large central laboratory affected the proportion of individuals with Lp(a) result above clinical thresholds.

Methods

We studied nationwide clinical laboratory data including 185,493 unique individuals (47.7 % women) aged 18-50 years with 272,463 Lp(a) measurements using Roche (2000-2009) and Siemens Lp(a) assay (2009-2019).

Results

While the majority of individuals (66-75 %) had low levels of Lp(a) (<30 mg/dL) independent of the assay used, the Roche assay detected 20 % more individuals with Lp(a) >50 mg/dL, 40 % more individuals with Lp(a) >100 mg/dL and 80 % more individuals with Lp(a) > 180 mg/dL than the currently used Siemens assay, likely due to calibration differences.

Conclusion

Transitioning from one Lp(a) immunoassay to another had significant impact on Lp(a) results, particularly in individuals approaching clinically relevant Lp(a) thresholds.

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在临床环境中从一种脂蛋白（a）检测方法过渡到另一种检测方法的实际影响

背景和目的不同的脂蛋白（a）[Lp（a）]检测方法可能会影响个人的风险分层，从而影响临床决策。方法我们研究了全国范围内的临床实验室数据，其中包括 185,493 名年龄在 18-50 岁之间的独特个体（47.7% 为女性），使用罗氏（2000-2009 年）和西门子（2009-2019 年）脂蛋白（a）测定法进行了 272,463 次脂蛋白（a）测量。结果虽然大多数人（66-75%）的脂蛋白（a）水平较低（30 毫克/分升），与所使用的检测方法无关，但与目前使用的西门子检测方法相比，罗氏检测方法检测出的脂蛋白（a）为 50 毫克/分升的人多 20%，脂蛋白（a）为 100 毫克/分升的人多 40%，脂蛋白（a）为 180 毫克/分升的人多 80%，这可能是由于校准差异造成的。结论从一种脂蛋白（a）免疫测定方法过渡到另一种方法会对脂蛋白（a）结果产生重大影响，尤其是在接近临床相关脂蛋白（a）阈值的个体中。

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