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Updated: Apr 20, 2026
Electrowetting-based Digital Microfluidics Platform for Automated Enzyme-linked Immunosorbent Assay
Published on: February 23, 2020
Validation of a microfluidic platform to measure total therapeutic antibodies and incurred sample reanalysis
Ivan Magana1, Chris R Macaraeg, Liana Zhang
1Department of Pharmacokinetics & Drug Metabolism, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA.
Background:
A microfluidic platform-based assay was validated to measure a humanized or fully human IgG in rat serum samples.
Materials & Methods:
The cumulative assessment for accuracy and precision was performed with three accuracy and precision runs.
Results:
The inter-assay accuracy (mean %bias) ranged from -4.3 to 3.8%, and inter-batch %CV ranged from 5.0 to 9.2%. The method acceptance criterion was determined as 15% total error. The assay dynamic range was 50 to 10000 ng/ml. Incurred sample reanalysis passed with 95% of samples meeting incurred sample reanalysis acceptance criteria. Potential carryover effect was not observed.
Conclusion:
This study demonstrated the need for evaluating additional platform-specific processes when new technologies are employed to ensure the reproducibility of a successfully validated microfluidic platform method.
