Department of Neurology, Tokyo Metropolitan Institute for Geriatrics and Gerontology, Tokyo, Japan.
Integrated Research Initiative for Living Well with Dementia, Tokyo Metropolitan Institute for Geriatrics and Gerontology, Tokyo, Japan.
J Alzheimers Dis. 2024;99(3):1077-1092. doi: 10.3233/JAD-240185.
Although Lumipulse assays and conventional ELISA are strongly correlated, the precise relationship between their measured values remains undetermined.
To determine the relationship between Lumipulse and ELISA measurement values.
Patients who underwent cerebrospinal fluid (CSF) Alzheimer's disease (AD) biomarker measurements and consented to biobanking between December 2021 and June 2023 were included. The relationship between values measured via Lumipulse assays and conventional ELISA were evaluated by Passing-Bablok analyses for amyloid-β 1-42 (Aβ42), total tau (t-tau), and phospho-tau 181 (p-tau 181). Studies using both assays were systematically searched for in PubMed and summarized after quality assessment.
Regression line slopes and intercepts were 1.41 (1.23 to 1.60) and -77.8 (-198.4 to 44.5) for Aβ42, 0.94 (0.88 to 1.01) and 98.2 (76.9 to 114.4) for t-tau, and 1.60 (1.43 to 1.75) and -21.1 (-26.9 to -15.6) for p-tau181. Spearman's correlation coefficients were 0.90, 0.95, and 0.95 for Aβ42, t-tau, and p-tau181, respectively. We identified 13 other studies that included 2,117 patients in total. Aβ42 slope varied among studies, suggesting inter-lab difference of ELISA. The slope and intercept of t-tau were approximately 1 and 0, respectively, suggesting small proportional and systematic differences. Conversely, the p-tau181 slope was significantly higher than 1, distributed between 1.5-2 in most studies, with intercepts significantly lower than 0, suggesting proportional and systematic differences.
We characterized different relationship between measurement values for each biomarker, which may be useful for understanding the differences in CSF biomarker measurement values on different platforms and for future global harmonization.
尽管 Lumipulse 分析和传统 ELISA 具有很强的相关性，但它们测量值之间的确切关系仍未确定。
确定 Lumipulse 和 ELISA 测量值之间的关系。
纳入 2021 年 12 月至 2023 年 6 月期间进行脑脊液（CSF）阿尔茨海默病（AD）生物标志物检测并同意进行生物样本库的患者。通过 Passing-Bablok 分析评估 Lumipulse 分析和传统 ELISA 测量的 Aβ42、总 tau（t-tau）和磷酸化 tau181（p-tau181）值之间的关系。在 PubMed 中系统地搜索了使用这两种分析的研究，并在质量评估后进行了总结。
Aβ42 的回归线斜率和截距分别为 1.41（1.23 至 1.60）和-77.8（-198.4 至 44.5），t-tau 为 0.94（0.88 至 1.01）和 98.2（76.9 至 114.4），p-tau181 为 1.60（1.43 至 1.75）和-21.1（-26.9 至-15.6）。Spearman 相关系数分别为 0.90、0.95 和 0.95。我们还确定了另外 13 项共纳入 2117 名患者的研究。Aβ42 的斜率因研究而异，提示 ELISA 存在实验室间差异。t-tau 的斜率和截距分别约为 1 和 0，提示存在小比例和系统差异。相反，p-tau181 的斜率明显高于 1，在大多数研究中分布在 1.5-2 之间，截距明显低于 0，提示存在比例和系统差异。
我们描述了每个生物标志物测量值之间的不同关系，这对于理解不同平台上 CSF 生物标志物测量值的差异以及未来的全球标准化可能是有用的。
