Feasibility of using PALSAR technology as a signal amplifier for antibody bridging assay

The immunogenicity testing of oligonucleotide drugs using an antibody bridging assay has been scarcely investigated. We developed a highly sensitive antibody bridging assay model and assessed it using probe alteration link self-assembly reactions (PALSAR) technology as a signal amplifier. Methods: The concentration of each probe was optimized, and the bridging assay model was compared with and without signal amplification. Cut-point and analytical sensitivity were determined, and accuracy, precision and drug tolerance were evaluated. Results: The PALSAR bridging assay achieved a net signal 21-36 times higher than that obtained with the conventional method. The analytical sensitivity achieved was 48.8 ng/ml, with adequate accuracy, precision and drug tolerance. Conclusion: PALSAR technology is feasible for developing an antibody bridging assay using oligonucleotides as capture and detection probes.

Automated summary

In this study, a highly sensitive antibody bridging assay model was developed and successfully applied to the immunogenicity testing of oligonucleotide drugs. By utilizing probe alteration link self-assembly reactions as a signal amplifier, the bridging assay model achieved higher signal and improved analytical sensitivity.