Alzheimer's Clinical and Translational Research Unit, Department of Neurology, Massachusetts General Hospital, Harvard Medical School, 114 16th Street, Room 2300, Charlestown, Boston, MA, 02129, USA.
Meso Scale Diagnostics, LLC., Rockville, MD, USA.
Sci Rep. 2024 Jan 5;14(1):629. doi: 10.1038/s41598-024-51334-x.
A growing literature suggests that plasma levels of tau phosphorylated at amino acid 217 (pTau217) performs similarly to cerebrospinal fluid (CSF) biomarkers and PET imaging to detect amyloid pathology and to provide diagnostic and prognostic information in Alzheimer's disease (AD), but a significant limiting factor thus far has been a lack of widely available immunoassays. We evaluated a novel pTau217 S-PLEX® assay developed by Meso Scale Discovery (MSD; Rockville, MD) in plasma from 131 individuals with AD confirmed by CSF biomarkers and controls. Technical performance of the assay was excellent with an LLOQ of 1.84 pg/mL and intra/interplate CVs of 5.5% (0.3-15.0%) and 5.7% (range 0.3-13.4%), respectively. The pTau217 plasma assay differentiated AD and controls with an AUC of 0.98 (95% CI 0.96-1.0) and pTau217 levels were 3.9-fold higher in individuals with AD. This performance was significantly better than what was observed for plasma pTau181, performed in parallel, and comparable to published data on existing pTau217 assays. While further clinical validation and head-to-head comparisons are needed to fully establish the role for the novel pTau217 S-PLEX assay, these data demonstrate the utility of the assay to detect AD pathology.
越来越多的文献表明，磷酸化氨基酸 217 位的 tau 蛋白（pTau217）的血浆水平与脑脊液（CSF）生物标志物和 PET 成像具有相似的性能，可用于检测淀粉样蛋白病理，并在阿尔茨海默病（AD）中提供诊断和预后信息，但迄今为止一个重要的限制因素是缺乏广泛可用的免疫测定法。我们评估了 Meso Scale Discovery（MSD；马里兰州罗克维尔）开发的一种新型 pTau217 S-PLEX® 测定法，该测定法在通过 CSF 生物标志物和对照物确认的 131 名 AD 患者的血浆中进行了评估。该测定法的技术性能非常出色，LLOQ 为 1.84pg/mL，批内/批间 CV 分别为 5.5%（0.3-15.0%）和 5.7%（范围 0.3-13.4%）。该 pTau217 血浆测定法可区分 AD 和对照物，AUC 为 0.98（95%CI 0.96-1.0），AD 患者的 pTau217 水平高出 3.9 倍。与平行进行的血浆 pTau181 相比，这一性能明显更好，与现有 pTau217 测定法的已发表数据相当。虽然需要进一步的临床验证和头对头比较来充分确定新型 pTau217 S-PLEX 测定法的作用，但这些数据表明该测定法可用于检测 AD 病理学。
