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dc.contributor.authorLifke, V.
dc.contributor.authorKollmorgen, G.
dc.contributor.authorManuilova, E.
dc.date.accessioned2019-09-13T14:49:33Z
dc.date.available2019-09-13T14:49:33Z
dc.date.issued2019
dc.identifier.urihttps://www.scopus.com/inward/record.uri?eid=2-s2.0-85066258511&doi=10.1016%2fj.clinbiochem.2019.05.005&partnerID=40&md5=47660ed88aacf3e82bf6383b115c2ac2
dc.identifier.urihttp://hdl.handle.net/10713/10619
dc.description.abstractBackground: Total tau (tTau) and phosphorylated 181P tau (pTau) are supportive diagnostic cerebrospinal fluid (CSF) biomarkers for Alzheimer's disease. Manual CSF tau assays are limited by lot-to-lot and between-laboratory variability and long incubation/turnaround times. Elecsys® 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. Methods: Analytical performance, reproducibility, method comparisons with commercially available assays, and lot-to-lot and platform comparability (cobas e 601/411) of the Elecsys® CSF assays were assessed. Tau distributions and concentration ranges were evaluated in CSF samples from two clinical cohorts. Results: Both assays showed high sensitivity (limit of quantitation [LoQ]: 63 pg/mL [tTau]; 4 pg/mL [pTau]) and linearity over the measuring range (80–1300 pg/mL; 8–120 pg/mL), which covered the entire concentration range measured in clinical samples. Lot-to-lot and platform comparability demonstrated good consistency (Pearson's r: 0.998; 1.000). Multicenter evaluation coefficients of variation (CVs): repeatability, < 1.8%; intermediate precision, < 2.8%; between-laboratory variability, < 2.7% (both assays); and total reproducibility, < 6.7% (tTau) and < 4.7% (pTau). Elecsys® CSF assays demonstrated good correlation with commercially available tau assays. Conclusions: Elecsys® Total-Tau CSF and Phospho-Tau (181P) CSF assays demonstrate good analytical performance with clinically relevant measuring ranges; data support their use in clinical trials and practice.en_US
dc.description.urihttps://doi.org/10.1016/j.clinbiochem.2019.05.005en_US
dc.language.isoen-USen_US
dc.publisherElsevier Inc.en_US
dc.relation.ispartofClinical Biochemistry
dc.subjectAlzheimer's diseaseen_US
dc.subjectBiomarkersen_US
dc.subjectCSFen_US
dc.subjectFully automated immunoassayen_US
dc.subjectPhosphorylated tauen_US
dc.subjectTotal tauen_US
dc.titleElecsys® Total-Tau and Phospho-Tau (181P) CSF assays: Analytical performance of the novel, fully automated immunoassays for quantification of tau proteins in human cerebrospinal fluiden_US
dc.typeArticleen_US
dc.identifier.doi10.1016/j.clinbiochem.2019.05.005


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