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Clinical validation of the PrecivityAD2 blood test: A mass spectrometry‐based test with algorithm combining %p‐tau217 and Aβ42/40 ratio to identify presence of brain amyloid

Title: Clinical validation of the PrecivityAD2 blood test: A mass spectrometry‐based test with algorithm combining %p‐tau217 and Aβ42/40 ratio to identify presence of brain amyloid
Authors: Meyer, Matthew R; Kirmess, Kristopher M; Eastwood, Stephanie; Wente‐Roth, Traci L; Irvin, Faith; Holubasch, Mary S; Venkatesh, Venky; Fogelman, Ilana; Monane, Mark; Hanna, Lucy; Rabinovici, Gil D; Siegel, Barry A; Whitmer, Rachel A; Apgar, Charles; Bateman, Randall J; Holtzman, David M; Irizarry, Michael; Verbel, David; Sachdev, Pallavi; Ito, Satoshi; Contois, John; Yarasheski, Kevin E; Braunstein, Joel B; Verghese, Philip B; West, Tim
Source: Alzheimer's & Dementia, vol 20, iss 5
Publisher Information: eScholarship, University of California
Publication Year: 2024
Collection: University of California: eScholarship
Subject Terms: 32 Biomedical and Clinical Sciences (for-2020); 3209 Neurosciences (for-2020); 3202 Clinical Sciences (for-2020); Biomedical Imaging (rcdc); Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD) (rcdc); Neurosciences (rcdc); Dementia (rcdc); Acquired Cognitive Impairment (rcdc); Brain Disorders (rcdc); Alzheimer's Disease (rcdc); Clinical Research (rcdc); Neurodegenerative (rcdc); Aging (rcdc); 4.1 Discovery and preclinical testing of markers and technologies (hrcs-rac); 4.2 Evaluation of markers and technologies (hrcs-rac); Neurological (hrcs-hc); Humans (mesh); Amyloid beta-Peptides (mesh); Female (mesh); Male (mesh); tau Proteins (mesh); Alzheimer Disease (mesh); Aged (mesh); Algorithms (mesh); Positron-Emission Tomography (mesh); Peptide Fragments (mesh); Brain (mesh); Biomarkers (mesh); Mass Spectrometry (mesh); Middle Aged (mesh)
Time: 3179 - 3192
Description: BACKGROUND: With the availability of disease-modifying therapies for Alzheimer's disease (AD), it is important for clinicians to have tests to aid in AD diagnosis, especially when the presence of amyloid pathology is a criterion for receiving treatment. METHODS: High-throughput, mass spectrometry-based assays were used to measure %p-tau217 and amyloid beta (Aβ)42/40 ratio in blood samples from 583 individuals with suspected AD (53% positron emission tomography [PET] positive by Centiloid>25). An algorithm (PrecivityAD2 test) was developed using these plasma biomarkers to identify brain amyloidosis by PET. RESULTS: The area under the receiver operating characteristic curve (AUC-ROC) for %p-tau217 (0.94) was statistically significantly higher than that for p-tau217 concentration (0.91). The AUC-ROC for the PrecivityAD2 test output, the Amyloid Probability Score 2, was 0.94, yielding 88% agreement with amyloid PET. Diagnostic performance of the APS2 was similar by ethnicity, sex, age, and apoE4 status. DISCUSSION: The PrecivityAD2 blood test showed strong clinical validity, with excellent agreement with brain amyloidosis by PET.
Document Type: article in journal/newspaper
File Description: application/pdf
Language: unknown
Relation: qt5hw1q94s; https://escholarship.org/uc/item/5hw1q94s; https://escholarship.org/content/qt5hw1q94s/qt5hw1q94s.pdf
DOI: 10.1002/alz.13764
Availability: https://escholarship.org/uc/item/5hw1q94s; https://escholarship.org/content/qt5hw1q94s/qt5hw1q94s.pdf; https://doi.org/10.1002/alz.13764
Rights: CC-BY-NC-ND
Accession Number: edsbas.57FB5FA0
Database: BASE