Confirmatory cut point has limited ability to make accurate classifications in immunogenicity assays
| Autor: | Lorin Roskos, Meina Liang, Nancy Lee, Robert J Kubiak, Rosalinda Hgp Arends, Jianchun Zhang |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
Oncology
medicine.medical_specialty business.industry Immunogenicity 010401 analytical chemistry Clinical Biochemistry General Medicine 01 natural sciences 0104 chemical sciences Analytical Chemistry 03 medical and health sciences Medical Laboratory Technology 0302 clinical medicine Internal medicine Medicine Humans Biological Assay General Pharmacology Toxicology and Pharmaceutics business Cut-point 030215 immunology |
| Zdroj: | Bioanalysis. 12(4) |
| ISSN: | 1757-6199 |
| Popis: | Aim: Competitive inhibition with excess unlabeled drug is used to confirm the presence of antidrug antibodies (ADA) in study samples. We evaluated specific and nonspecific responses from both drug-naive and drug-treated subjects to identify conditions required by the confirmatory assay to make accurate ADA classifications. Results: Nonspecific signal measured in drug-naive samples used to determine assay cut points was uniformly low and close to the screening cut point. Confirmatory assays performed on incurred study samples with nonspecific responses significantly above the level observed during cut point determination resulted in incorrect ADA classifications. Conclusion: Intensity of confirmatory response should be proportional to the screening response and therefore, to ensure accurate ADA classifications, the confirmatory responses cannot be considered as independent but need to be evaluated in relation to the screening responses. |
| Databáze: | OpenAIRE |
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