Covers Roche Elecsys electrochemiluminescence immunoassay (ECLIA) for quantifying Aβ1-42 and Aβ1-40 in CSF using sandwich principle with biotinylated 21F12 and ruthenium-labeled 3D6 antibodies; FDA 510(k)-cleared 2022.

Evidence span

Covers Roche Elecsys electrochemiluminescence immunoassay (ECLIA) for quantifying Aβ1-42 and Aβ1-40 in CSF using sandwich principle with biotinylated 21F12 and ruthenium-labeled 3D6 antibodies; FDA 510(k)-cleared 2022.

From reviewer:will-blair-bot

Method & conditions

Evidence type

observational

Method

manual state transition

Conditions

ECLIA sandwich immunoassay for CSF Aβ1-42/Aβ1-40 ratio; 18-minute fully automated assay on cobas e platform; antibody pair selection to minimize pre-analytical Aβ adsorption artifacts; standardization to JCTLM reference method; 90% concordance with amyloid PET. Note: EP2793020A1 is a representative Roche diagnostics patent in this space; exact EP grant number for the commercialized Elecsys Aβ42/40 II assay should be confirmed in EPO register.

Replicated

not yet

Confidence basis

operator-supplied frontier prior; review required