Optimization and qualification of an Fc Array assay for assessments of antibodies against HIV-1/SIV.
The Fc Array is a multiplexed assay that assesses the Fc domain characteristics of antigen-specific antibodies with the potential to evaluate up to 500 antigen specificities simultaneously. Antigen-specific antibodies are captured on antigen-conjugated beads and their functional capacity is probed via an array of Fc-binding proteins including antibody subclassing reagents, Fcγ receptors, complement proteins, and lectins. Here we present the results of the optimization and formal qualification of the Fc Array, performed in compliance with Good Clinical Laboratory Practice (GCLP) guidelines. Assay conditions were optimized for performance and reproducibility, and the final version of the assay was then evaluated for specificity, accuracy, precision, limits of detection and quantitation, linearity, range and robustness.
Duke Scholars
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Related Subject Headings
- Simian immunodeficiency virus
- Simian Immunodeficiency Virus
- Simian Acquired Immunodeficiency Syndrome
- Sensitivity and Specificity
- Reproducibility of Results
- Reference Standards
- Protein Binding
- Practice Guidelines as Topic
- Microspheres
- Macaca mulatta
Citation
Published In
DOI
EISSN
Publication Date
Volume
Start / End Page
Location
Related Subject Headings
- Simian immunodeficiency virus
- Simian Immunodeficiency Virus
- Simian Acquired Immunodeficiency Syndrome
- Sensitivity and Specificity
- Reproducibility of Results
- Reference Standards
- Protein Binding
- Practice Guidelines as Topic
- Microspheres
- Macaca mulatta