Multicenter Analytical Validation of Aβ40 Immunoassays.

ABSTRACT:

Background

Before implementation in clinical practice, biomarker assays need to be thoroughly analytically validated. There is currently a strong interest in implementation of the ratio of amyloid-β peptide 1-42 and 1-40 (Aβ42/Aβ40) in clinical routine. Therefore, in this study, we compared the analytical performance of six assays detecting Aβ40 in cerebrospinal fluid (CSF) in six laboratories according to a recently standard operating procedure (SOP) developed for implementation of ELISA assays for clinical routine.

Methods

Aβ40 assays of six vendors were validated in up to three centers per assay according to recently proposed international consensus validation protocols. The performance parameters included sensitivity, precision, dilutional linearity, recovery, and parall

SUBMITTER: van Waalwijk van Doorn LJC 

PROVIDER: S-EPMC5497061 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature