Development and validation of a triplex assay to study an antibody cocktail against Ebola virus in cynomolgus serum
Bioanalysis | April 1, 2021
Wang B, Han P, Mo L, Wang M, Liu Y, Dong L, Zhou Q, Dong K and Song H
Bioanalysis. 2021
Background: To support the rapid development of an antibody cocktail against Ebola virus and avoid unnecessary exposure to infectious environments, an automatic and fast turnover triplex assay was developed using Simoa® (Quanterix Corporation, MA, USA).
Materials & methods: A robust triplex assay was developed and validated for simultaneous quantification of the antibody cocktail against Ebola virus in cynomolgus serum.
Results: The assay had a quantitation range of 78.1–5000 ng/ml. The intra- and interassay precisions (%CV) were within 11.4 and 13.9%, and the accuracies (%RE) were within -10.8 to 6.8%, respectively. Cross-reactivity was evaluated, and the results met the acceptance criteria.
Conclusion: The assay was successfully applied to a pharmacokinetics study following a single-dose intravenous administration of 10 mg/kg the antibody cocktail against Ebola virus to cynomolgus monkeys.