罗氏12月8日宣布，其Elecsys β-Amyloid (1-42)和Elecsys Phospho-Tau (181P) CSF检测试剂盒已获得美国食品和药物管理局（FDA）的510(k)上市许可。这是2款针对正接受评估阿尔茨海默症的55岁及以上成年患者的检测试剂盒。罗氏的Elecsys AD CSF检测试剂盒已在全球45个国家注册，包括接受欧盟CE认证的国家。
Elecsys (R) Total-Tau CSF and Phospho-Tau (181P) CSF immunoassays were developed for fully automated cobas e analyzers, allowing broader access in clinical practice and trials.Lifke, ValeriaKollmorgen, GwendlynManuilova, EkaterinaOelschlaegel, TobiasHillringhaus, LarsWidmann, Monikavon Arnim, ...
罗氏12月8日宣布,其Elecsys β-Amyloid (1-42)和Elecsys Phospho-Tau (181P) CSF检测试剂盒已获得美国食品和药物管理局(FDA)的510(k)上市许可。这是2款针对正接受评估阿尔茨海默症的55岁及以上成年患者的检测试剂盒。罗氏的Elecsys AD CSF检测试剂盒已在全球45个国家注册,包括接受欧盟CE认证的国家。
阿尔茨海默病脑脊液检测:在神经退行性疾病领域,Elecsys也有出色的表现。特别是针对阿尔茨海默病的脑脊液检测,Elecsys提供了β-Amyloid (1-42) CSF II、Phospho-Tau (181P) CSF和Total-Tau CSF等关键试剂,这些试剂能够检测脑脊液中的特定标志物,为阿尔茨海默病的早期诊断和治疗提供重要依据。 肝...
CSF samples from patients in two multicentre longitudinal studies (ADNI, n = 619; BioFINDER, n = 431) were analysed. Aβ(1–42), tTau and pTau CSF concentrations were measured using Elecsys CSF immunoassays, and tTau/Aβ(1–42) and pTau/Aβ(1–42) ratios calculated. ...
2024年7月,罗氏诊断阿尔茨海默病脑脊液系列试剂盒(包括 Elecsys® β-Amyloid (1-42) CSF II、Elecsys® Phospho-Tau (181P) CSF、Elecsys® Total-Tau CSF 检测试剂,以及适配的定标液、质控品等在内 的9个产品)正式获得海南省药品监督管理局批准,作为进口临床急需医疗器械,即将落地上海交通大学医学院附属瑞...
MULTICENTER EVALUATION OF THE ANALYTICAL CHARACTERISTICS OF THE ELECSYS® TOTAL-TAU CEREBROSPINAL FLUID (CSF) AND ELECSYS® PHOSPHO-TAU (181P) CSF IMMUNOASSAYSdoi:10.1016/j.jalz.2018.06.291Gwendlyn KollmorgenCharlotte E. TeunissenRobert H. Christenson...
Phospho-tauTotal-tauBlood contaminationStorage durationGlass vialsThawingAlzheimers disease is considered a neurodegenerative disease and is diagnosed by exclusion, while the detection of specific cerebrospinal fluid (CSF) biomarkers, namely amyloid-beta (Aβ) peptides Aβ1–42(A42), phospho-tau (181P...
Compared with the first‐generation (Gen1), second‐generation (Gen2) Elecsys cerebrospinal fluid (CSF) immunoassays (currently under development, Roche Diagnostics International Ltd) for detection of β‐amyloid(1–42) (Abeta42), phospho‐tau(181P) (pTau) and total‐tau (tT...