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Development and validation of enzyme-linked immunosorbent assays for the measurement of infliximab and anti-drug antibody levels.


ABSTRACT: Infliximab and its anti-drug antibody (ADA) serum concentrations exhibit a strong correlation with clinical response and loss of response. The use of therapeutic drug monitoring to measure the concentration of infliximab and ADA can facilitate clinical decision-making, helping patients attain optimal therapeutic effects. However, there are still limitations to the existing infliximab and its ADA detection methods. Therefore, this study aimed to develop and validate enzyme-linked immunosorbent assay (ELISA)-based methods for measuring infliximab and its ADA levels in human plasma according to the general recommendations for immunoassays. Free infliximab is bound by recombinant TNF-α and detected using HRP-labeled anti-human antibody. The ADA is captured by on-plate-coated infl

SUBMITTER: Xiang D 

PROVIDER: S-EPMC10682623 | biostudies-literature | 2023 Nov

REPOSITORIES: biostudies-literature