Determination of Anti-Mesenchymal Stem Cell Antibody in Cynomolgus Monkey Serum by Flow Cytometry and Its Application / 医药导报
Herald of Medicine
; (12): 1791-1795, 2023.
Article
en Zh
| WPRIM
| ID: wpr-1023651
Biblioteca responsable:
WPRO
ABSTRACT
Objective To develop an accurate,rapid and sensitive flow cytometry method for the determination of anti-mesenchymal stem cell antibody in cynomolgus monkey serum.Methods After the solutions of mesenchymal stem cell were centrifuged and washed,and the suspension was taken,positive controls or actual samples were added and incubated with mesenchymal stem cell,then were incubated with protein L-PE solution.After the removal of the free protein L-PE,the mean fluorescence intensity of the PE was detected by flow cytometry.Results The method sensitivity is 115.54 ng·mL-1,far higher than the non-clinical research recommended sensitivity of 250-500 ng·mL-1.The precision of intra-assay and inter-assay were less than 20%.Assay cut points,low positive control concentration determination,sensitivity,precision and stability were validated in this study.Conclusion The method is proved to be sensitive,specific,rapid and suitable for the determination of anti-mesenchymal stem cell antibody in monkey serum and immunogenicity study.
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1
Base de datos:
WPRIM
Idioma:
Zh
Revista:
Herald of Medicine
Año:
2023
Tipo del documento:
Article