Bioanalysis Zone

Validation of a microfluidic platform to measure total therapeutic antibodies and incurred sample reanalysis performance


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.

To view restricted content, please:

Leave A Comment

Please wait...

Bioanalysis Zone New Investigator Award

Why not start this year by doing something good by nominating an early career scientist for the Bioanalysis Zone New Investigator Award. Complete the details below to register your interest!