Development and validation of an isoform-independent monoclonal antibody-based ELISA for measurement of lipoprotein(a).

ABSTRACT: The study aims were to develop a new isoform-independent enzyme-linked immunoassay (ELISA) for the measurement of lipoprotein(a) [Lp(a)], validate its performance characteristics, and demonstrate its accuracy by comparison with the gold-standard ELISA method and an LC-MS/MS candidate reference method, both developed at the University of Washington. The principle of the new assay is the capture of Lp(a) with monoclonal antibody LPA4 primarily directed to an epitope in apolipoprotein(a) KIV₂ and its detection with monoclonal antibody LPA-KIV9 directed to a single antigenic site present on KIV₉. Validation studies were performed following the guidelines of the Clinical Laboratory Improvement Amendments and the College of American Pathologists. The analytical measuring ra

SUBMITTER: Marcovina SM 

PROVIDER: S-EPMC9352967 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature