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

Publication ,  Journal Article
Brown, EP; Weiner, JA; Lin, S; Natarajan, H; Normandin, E; Barouch, DH; Alter, G; Sarzotti-Kelsoe, M; Ackerman, ME
Published in: J Immunol Methods
April 2018

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.

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Published In

J Immunol Methods

DOI

EISSN

1872-7905

Publication Date

April 2018

Volume

455

Start / End Page

24 / 33

Location

Netherlands

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

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Brown, E. P., Weiner, J. A., Lin, S., Natarajan, H., Normandin, E., Barouch, D. H., … Ackerman, M. E. (2018). Optimization and qualification of an Fc Array assay for assessments of antibodies against HIV-1/SIV. J Immunol Methods, 455, 24–33. https://doi.org/10.1016/j.jim.2018.01.013
Brown, Eric P., Joshua A. Weiner, Shu Lin, Harini Natarajan, Erica Normandin, Dan H. Barouch, Galit Alter, Marcella Sarzotti-Kelsoe, and Margaret E. Ackerman. “Optimization and qualification of an Fc Array assay for assessments of antibodies against HIV-1/SIV.J Immunol Methods 455 (April 2018): 24–33. https://doi.org/10.1016/j.jim.2018.01.013.
Brown EP, Weiner JA, Lin S, Natarajan H, Normandin E, Barouch DH, et al. Optimization and qualification of an Fc Array assay for assessments of antibodies against HIV-1/SIV. J Immunol Methods. 2018 Apr;455:24–33.
Brown, Eric P., et al. “Optimization and qualification of an Fc Array assay for assessments of antibodies against HIV-1/SIV.J Immunol Methods, vol. 455, Apr. 2018, pp. 24–33. Pubmed, doi:10.1016/j.jim.2018.01.013.
Brown EP, Weiner JA, Lin S, Natarajan H, Normandin E, Barouch DH, Alter G, Sarzotti-Kelsoe M, Ackerman ME. Optimization and qualification of an Fc Array assay for assessments of antibodies against HIV-1/SIV. J Immunol Methods. 2018 Apr;455:24–33.
Journal cover image

Published In

J Immunol Methods

DOI

EISSN

1872-7905

Publication Date

April 2018

Volume

455

Start / End Page

24 / 33

Location

Netherlands

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