Test system for the detection of binding antibodies to interferon beta-1a for clinical use

Abstract

Test system for determining the presence of binding antibodies to interferon beta-1a (BAB to IFN beta-1a) in serum using ELISA has been developed. The validation included sensitivity, selectivity, specificity, precision and accuracy, robustness, stability, suitability of the test system studies. The applicability of the mentioned test system has been approved for the use in clinical studies for the evaluation of interferon beta-1a immunogenicity (pegylated and non-pegylated forms).

Keywords

• интерферон бета 1а
• иммуногенность
• твердофазный иммуноферментный анализ (ифа)
• связывающие антитела (сат)
• антитела к препарату
• рассеянный склероз
• биоаналитические методы исследования
• клинические исследования
• interferon beta-1a
• immunogenicity
• enzyme linked immunosorbent assay (elisa)
• binding antibodies (bab)
• anti-drug antibodies (adas)
• multiple sclerosis (ms)
• bioanalytical methods
• clinical studies