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Development and Validation of an Ultrasensitive Single Molecule Array Digital Enzyme-linked Immunosorbent Assay for Human Interferon-α
Published on: June 14, 2018
Development and validation of an enzyme-linked immunosorbent assay to measure adalimumab concentration
Céline Desvignes1,2, Soujanya R Edupuganti1, François Darrouzain1,2
11Université François Rabelais de Tours, CNRS UMR 7292, Tours, France.
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.
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