Development and validation of an enzyme-linked immunosorbent assay to measure adalimumab concentration

Autor: Anne-Claire Duveau, Céline Desvignes, Gilles Paintaud, Soujanya Ratna Edupuganti, François Darrouzain, Denis Mulleman, Amy Loercher
Přispěvatelé: Génétique, immunothérapie, chimie et cancer (GICC), UMR 7292 CNRS [2012-2017] (GICC UMR 7292 CNRS), Université de Tours-Centre National de la Recherche Scientifique (CNRS), Université de Tours (UT)-Centre National de la Recherche Scientifique (CNRS)
Jazyk: angličtina
Rok vydání: 2015
Předmět:
musculoskeletal diseases
Validation study
[SDV]Life Sciences [q-bio]
Clinical Biochemistry
Anti-Inflammatory Agents
Enzyme-Linked Immunosorbent Assay
Pharmacology
Analytical Chemistry
[SDV.SP.MED]Life Sciences [q-bio]/Pharmaceutical sciences/Medication
Limit of Detection
medicine
Adalimumab
Humans
General Pharmacology
Toxicology and Pharmaceutics
skin and connective tissue diseases
Detection limit
chemistry.chemical_classification
medicine.diagnostic_test
business.industry
Reproducibility of Results
General Medicine
[SDV.IMM.IMM]Life Sciences [q-bio]/Immunology/Immunotherapy
[SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences
humanities
3. Good health
Medical Laboratory Technology
Enzyme
chemistry
Therapeutic drug monitoring
Therapeutic antibody
[SDV.SP.PHARMA]Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology
Drug Monitoring
business
medicine.drug
Zdroj: Bioanalysis
Bioanalysis, Future Science, 2015, 7 (10), pp.1253-1260. ⟨10.4155/bio.15.30⟩
ISSN: 1757-6180
1757-6199
DOI: 10.4155/bio.15.30⟩
Popis: Background: Adalimumab is a therapeutic antibody used for treating inflammatory diseases. To understand interindividual PK variability, there is a need to develop and validate an assay to measure serum adalimumab concentrations. Methods: An ELISA was developed on microtiter plates coated with TNF-α. Seven nonzero adalimumab standards ranging from 0.05 to 50 mg/l and three quality controls (0.2, 2.5 and 7 mg/l) were tested for their intra and interday precision on six occasions. Results: The LOD, LLOQ and ULOQ of the assay were 0.022, 0.073 and 9 mg/l, respectively. Conclusion: This method is accurate, reproducible and may be useful for PK studies and for therapeutic drug monitoring of adalimumab.
Databáze: OpenAIRE
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