Validation of a microfluidic platform to measure total therapeutic antibodies and incurred sample reanalysis performance
Virus protection. Vaccine search. Antibodies and viral infection. Immune defense of the body. Attack on antigens 3D illustration
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...
