Bilayer Nanopore Integrated Assay

 描述(由申请人提供)：由于肉毒杆菌神经毒素(BONT)在医疗和化妆品行业的治疗用途越来越多，目前需要新的表征技术来评估毒素活性(例如效力)，以便准确地给药。目前使用小鼠腹腔注射试验(也称为mLD50试验)来评估BONT的效力，该试验基于暴露于BONT后对一组小鼠实施安乐死的速率。这种测试不仅需要使用脊椎动物，与目前FDA和NIH的指南相冲突，而且它也很长，具有很高的可变性。MLD50检测需要3到4天，由于小鼠的敏感性和测试条件的不同，产生的错误率很高。电子生物科学公司(EBS)是一家专门将生物系统与高性能电子学相结合用于传感应用的公司，该公司建议开发一种体外替代mLD50检测的方法。这种建议的低成本化验方法将高度敏感，并能够快速表征完整的BONT机制，从而提供对目前不可能的毒素活动模式的洞察。

 DESCRIPTION (provided by applicant): Due to the growing number of therapeutic uses for botulinum neurotoxin (BoNT) within the medical and cosmetic industries, new characterization techniques are currently needed to assess toxin activity (e.g. potency) for accurate dose administration. BoNT potency is currently assessed using a mouse intraperitoneal injection assay, also known as the mLD50 assay, which is based on the rate at which a population of mice is euthanized upon exposure to BoNT. Not only does this assay require the use of vertebrate animals, conflicting with current FDA and NIH guidelines, it is also lengthy and has high variability. The mLD50 assay takes 3 to 4 days and yields high error rates due to variations in mouse sensitivity and test conditions. Electronic BioSciences, Inc. (EBS), which specializes in combining biological systems with high performance electronics for sensing applications, proposes to develop an in-vitro alternative to the mLD50 assay. This proposed low cost assay will be highly sensitive and capable of quickly characterizing the complete BoNT mechanism, thus providing insight into the toxin mode of activity not currently possible.