Novel assay format for totalanti-adeno-associated virus antibodydetection with low capsid consumption andbuilt-in specificity control: supplementary data

Aim: To develop an assay format for detection of total anti-adeno–associated virus 2 (AAV2) antibodieswith low capsid material consumption. Methods: An immune complex (IC) assay format was developed.The format is based on the formation of ICs in solution and their subsequent detection using an anti-AAV2antibody for capture and an antibody against the study species IgG for detection. Results: The feasibility ofthe IC assay for detection of preexisting and treatment-emergent anti-AAV2 antibodies was demonstratedin cynomolgus monkey and human serum samples, including samples from a preclinical study with AAV2-based therapies. Conclusion: The presented IC assay is an easy-to-perform total anti-AAV2 antibody assaythat requires a small amount of unlabeled capsid material and provides an intrinsic specificity control.

目的：开发一种可检测总抗腺相关病毒2型（adeno-associated virus 2, AAV2）抗体、且衣壳材料消耗量较低的检测体系。
方法：本研究开发了一种免疫复合物（immune complex, IC）检测体系。该体系基于溶液中免疫复合物的形成，后续以抗AAV2抗体作为捕获抗体、以针对研究物种IgG的抗体作为检测抗体完成复合物检测。
结果：本研究在食蟹猴及人血清样本（包括基于AAV2的疗法的临床前研究样本）中，验证了该IC检测体系用于检测预存及治疗诱导型抗AAV2抗体的可行性。
结论：本研究所提出的IC检测体系是一种操作简便的总抗AAV2抗体检测方法，仅需少量未标记的衣壳材料，且可提供内源性特异性对照。