Plasma brain-derived tau: analytical and clinical validation of the first commercial immunoassay.

ABSTRACT:

Background

Brain-derived tau (BD-tau) is a promising blood-based biomarker for neurodegeneration/brain injury in neurodegenerative and acute neurological disorders. However, widespread use is hampered by lack of commercial assays.

Methods

Using the Simoa^® HD-X analyzer, we evaluated the first commercial research-use only BD-tau Advantage PLUS assay's robustness, precision, dilution linearity, spike recovery, specificity, and limits of detection. Matrix effect was examined by comparing BD-tau levels in n=48 plasma/serum and n=20 plasma/CSF sample pairs. Clinical performance was examined in a traumatic brain injury (TBI) cohort.

Results

Twenty repeated measurements of three plasma samples gave intra- and inter-plate CVs ≤7.24%. A median drift of 8.00% (decrea

SUBMITTER: Nafash MN 

PROVIDER: S-EPMC12330458 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature