关键词: Alzheimer’s disease amyloid-β biomarkers cerebrospinal fluid chemiluminescent enzyme immunoassay (CLEIA) enzyme-linked immunosorbent assay (ELISA) fully-automated standardization systematic review tau proteins

Mesh : Alzheimer Disease / cerebrospinal fluid diagnosis Humans Biomarkers / cerebrospinal fluid Amyloid beta-Peptides / cerebrospinal fluid Enzyme-Linked Immunosorbent Assay / methods tau Proteins / cerebrospinal fluid Peptide Fragments / cerebrospinal fluid

来  源:   DOI:10.3233/JAD-240185   PDF(Pubmed)

Abstract:
UNASSIGNED: Although Lumipulse assays and conventional ELISA are strongly correlated, the precise relationship between their measured values remains undetermined.
UNASSIGNED: To determine the relationship between Lumipulse and ELISA measurement values.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
摘要:
尽管Lumipulse测定法和常规ELISA有很强的相关性,它们的测量值之间的精确关系仍未确定。
确定Lumipulse和ELISA测量值之间的关系。
包括在2021年12月至2023年6月期间接受脑脊液(CSF)阿尔茨海默病(AD)生物标志物测量并同意进行生物分析的患者。通过对淀粉样蛋白β1-42(Aβ42)的Passing-Bablok分析评估了通过Lumipulse测定法和常规ELISA测得的值之间的关系,总tau(t-tau),和磷酸-tau181(p-tau181)。在PubMed中系统地搜索使用两种测定法的研究,并在质量评估后进行总结。
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)。Aβ42,t-tau的Spearman相关系数分别为0.90、0.95和0.95,和p-tau181。我们确定了其他13项研究,总共包括2,117名患者。Aβ42斜率在研究中有所不同,提示ELISA的实验室间差异。t-tau的斜率和截距分别约为1和0,这表明比例和系统的差异很小。相反,p-tau181斜率明显高于1,在大多数研究中分布在1.5-2之间,截距显著低于0,表明比例和系统差异。
我们表征了每种生物标志物的测量值之间的不同关系,这可能有助于理解不同平台上CSF生物标志物测量值的差异以及未来的全球协调。
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