A simple and cost-effective assay for measuring anti-drug antibody in human patients treated with Adalimumab.

It has been reported that 90% of the anti-drug antibody (ADA) to Adalimumab in human patients bound to the TNF-binding area, resulted in the annual loss of responses to Adalimumab up to 24%. It is of urgency to develop a cost-effective and easy-to-use ADA diagnostic kit for diagnosis of potential drug-resistance in patients treated with Adalimumab in clinic hospitals to avoid the tremendous economic and human costs to patients and health-care providers. In this study, we reported the generations of mouse monoclonal and monkey polyclonal antibodies against Adalimumab as assay standards and positive quality controls respectively. A Bridging ELISA assay was successfully developed with a limit of detection (LOD) between 22-80ng/ml. The preliminary validation of assay was carried out first with 50 normal human sera, further validated by screening the ADA in 192 serum samples from monkeys treated with or without Adalimumab. Our data showed that the Bridging ELISA kit is very sensitive, highly specific and ready for study in human clinic trials.