Analytical assessment and validation of the ProteinSimple ELLA serum B-cell maturation antigen assay.

ABSTRACT:

Objectives

Soluble B-Cell Maturation Antigen (sBCMA) is a degradation product of plasma cell-bound BCMA found in serum. Serum sBCMA concentrations correlate with bone marrow plasma cellularity, making it an attractive biomarker for monitoring plasma cell disorders, such as multiple myeloma. Here we evaluated the automated BCMA immunoassay for the ProteinSimple ELLA, for the analysis of sBCMA.

Design & methods

Inter and intra-run precision was assessed through replicate sBCMA measurements at 3 different concentration levels. Linearity was determined through serial dilution of a high sBMCA patient sample. Accuracy was assessed through split specimen analysis on two separate lots of reagents. Stability was assessed at 3 temperature levels over 14 days. Cross-reactivity was asse

SUBMITTER: Kirchhoff DC 

PROVIDER: S-EPMC10821622 | biostudies-literature | 2024 Jan

REPOSITORIES: biostudies-literature