Performance of the FDA-cleared Lumipulse plasma #biomarker for amyloid pathology detection in #AlzheimerDisease varied by site and reagent lots, highlighting need for local assay verification and ongoing quality control. ja.ma/4q6gHdO
ja.maVariability in Clinical Performance of the FDA-Cleared Lumipulse p-Tau 217/β-Amyloid 42 Plasma RatioThis cross-sectional study evaluates the performance of the US Food and Drug Administration–cleared phosphorylated tau 217 (p-tau217) to β-amyloid 42 ratio cut points used to detect amyloid pathology associated with Alzheimer disease.
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