Practical limitations of using a 1.0% failure rate of low positive control in ADA assays
Detection and characterization of anti-drug antibodies (ADAs) is essential in developing and testing new biopharmaceuticals. One major practical challenge for validating and using ADA assays is setting and maintaining appropriate low positive control samples (LPCs) to ensure assay sensitivity at a 1.0% failure rate. This commentary explores the 1.0% failure rate approach to low positive controls and mitigation strategies for when this rate is exceeded.
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