Optimization of a whole blood phenotyping assay for enumeration of peripheral blood leukocyte populations in multicenter clinical trials. Hensley-McBain, T., Heit, A., Rosa, S.&nbsp;C.<nbsp>D., McElrath, Juliana, M., & Andersen-Nissen, E. Journal of Immunological Methods.
Optimization of a whole blood phenotyping assay for enumeration of peripheral blood leukocyte populations in multicenter clinical trials [link]Paper  doi  abstract   bibtex   
Vaccination with viral vectors or adjuvants can induce early changes in circulating peripheral blood leukocytes that are predictive of a protective immune response. In this study, we define an 11-color whole blood antibody staining Trucount Panel (TP1) to enumerate and phenotype the major leukocyte populations in a human vaccine experimental medicine trial setting. TP1 can be prepared up to 8 weeks prior to use, enabling bulk preparation at a central laboratory and distribution to clinical sites. Cells in whole blood must be stained within 4 h of draw to accurately detect the major cell populations. Staining of cells with TP1 followed by storage and shipping at −80 °C to a central laboratory has little to no effect on the cell concentrations observed. We also present data from an HIV vaccine multicenter clinical trial obtained using the optimized TP1 assay protocol and show that the data produced accurately correlates with complete blood count (CBC) data. Taken together, these data indicate the optimized TP1 panel assay can be used in a multicenter clinical trial setting to increase our understanding of systemic responses to vaccination or disease.
@article{ hensley-mcbain_optimization_????,
  title = {Optimization of a whole blood phenotyping assay for enumeration of peripheral blood leukocyte populations in multicenter clinical trials},
  issn = {0022-1759},
  url = {http://www.sciencedirect.com/science/article/pii/S0022175914001847},
  doi = {10.1016/j.jim.2014.06.002},
  abstract = {Vaccination with viral vectors or adjuvants can induce early changes in circulating peripheral blood leukocytes that are predictive of a protective immune response. In this study, we define an 11-color whole blood antibody staining Trucount Panel ({TP}1) to enumerate and phenotype the major leukocyte populations in a human vaccine experimental medicine trial setting. {TP}1 can be prepared up to 8 weeks prior to use, enabling bulk preparation at a central laboratory and distribution to clinical sites. Cells in whole blood must be stained within 4 h of draw to accurately detect the major cell populations. Staining of cells with {TP}1 followed by storage and shipping at −80 °C to a central laboratory has little to no effect on the cell concentrations observed. We also present data from an {HIV} vaccine multicenter clinical trial obtained using the optimized {TP}1 assay protocol and show that the data produced accurately correlates with complete blood count ({CBC}) data. Taken together, these data indicate the optimized {TP}1 panel assay can be used in a multicenter clinical trial setting to increase our understanding of systemic responses to vaccination or disease.},
  urldate = {2014-09-01},
  journal = {Journal of Immunological Methods},
  author = {Hensley-McBain, Tiffany and Heit, Antje and De Rosa, Stephen C. and McElrath, M. Juliana and Andersen-Nissen, Erica},
  keywords = {Assay optimization, Clinical trial, Experimental medicine trial, Multiparameter flow cytometry, Phenotyping, Trucount}
}
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