Optimization and qualification of an Fc Array assay for assessments of antibodies against HIV-1/SIV

• DOI: 10.1016/j.jim.2018.01.013
• Publication Date: 2018-02-01T14:08:16Z
• Authors: Eric P. Brown; Joshua A. Weiner; Shu Lin; Harini Natarajan; Erica Normandin; Dan H. Barouch; Galit Alter; Marcella Sarzotti...; Margaret E. Ackerman
• Keywords: Multiplex

The Fc Array is a multiplexed assay that assesses the domain characteristics of antigen-specific antibodies with potential to evaluate up 500 antigen specificities simultaneously. Antigen-specific are captured on antigen-conjugated beads and their functional capacity probed via an array Fc-binding proteins including antibody subclassing reagents, Fcγ receptors, complement proteins, lectins. Here we present results optimization formal qualification Array, performed in compliance Good Clinical Laboratory Practice (GCLP) guidelines. Assay conditions were optimized for performance reproducibility, final version was then evaluated specificity, accuracy, precision, limits detection quantitation, linearity, range robustness.