Lateral flow array for undeclared food allergens

项目摘要 至少有1500万美国人和5%的5岁以下儿童患有食物过敏。许多国家 现在对故意添加到食品中的常见过敏原有强制性的食品标签要求 产品.不幸的是，至少有170种已知的食物过敏原，未申报的食物过敏原可以 在运输、储存过程中，通过共用处理设备意外污染产品，或 由于欺诈和恐怖主义，并导致不良反应或死亡。该行业目前正在测试 使用单靶点ELISA、高分辨率质谱法或相关方法检测未申报的食物过敏原。 因此，食品加工商和检测实验室不断要求并需要一种敏感、特异、 易于使用的多过敏原测试，以尽量减少消费者的健康风险，以及食品召回的可能性。客观 该项目的主要目的是通过整合BioFront的专有技术， Akonni的FDA批准的Dx 2000侧流微阵列（LFA）平台中的单克隆过敏原抗体，以及 在符合ISO 17025标准的食品安全测试服务中验证系统性能。 在第1阶段，我们将验证BioFront单克隆抗体在Akonni侧支中的功能性和特异性。 建立一种检测方法，使每种目标过敏原的检测限达到1 ppm;以及 证明用加工食品提取物进行试验的可行性。这些结果将为第一阶段奠定基础 2项目，我们将扩大对所有剩余高优先级过敏原的检测;转移生产和 包装到Akonni的ISO 13485兼容的生产线;使用该平台开发AOAC批准的 MicroBac的分析方法;验证MicroBac前10名食品/测试的系统;并完成所有其他活动 系统和测试/分析服务的商业化所需的。完成这些里程碑将建立 一种新型的多路复用、组件解析过敏原检测产品和食品检测服务， 预计将提高消费者/公共安全，并为生产者提供一个负担得起的机制，以遵守 食品安全零容忍政策。

PROJECT SUMMARY At least 15 million Americans and 5% of children under 5 years old suffer from food allergies. Many countries now have mandatory food labeling requirements for common allergens that are intentionally added to food products. Unfortunately, there are at least 170 known food allergens, and undeclared food allergens can accidentally contaminate a product through shared processing equipment, during transport, in storage, or because of fraud and terrorism, and result in adverse reactions or fatalities. The industry currently tests for undeclared food allergens with single-target ELISAs, high-resolution mass spectrometry, or related methods. Food processors and testing laboratories therefore continuously request and need a sensitive, specific, and easy-to-use multi-allergen test to minimize consumer health risk, and the potential for food recalls. The objective of this project is to fill this important public health technology gap by incorporating BioFront's proprietary monoclonal allergen antibodies within Akonni's FDA-cleared Dx2000 lateral flow microarray (LFA) platform, and validating system performance within the context of MicroBac's ISO 17025-compliant food safety testing service. In Phase 1, we will verify the functionality and specificity of BioFront monoclonal antibodies in Akonni's lateral flow array; establish a test method that achieves a 1 ppm limit of detection for each of the target allergens; and demonstrate feasibility of the test with processed food extracts. These results will lay the foundation for a Phase 2 project, where we will expand the test for all remaining high-priority allergens; transfer manufacturing and packaging to Akonni's ISO13485-compliant production lines; use the platform to develop an AOAC-approved analysis method at MicroBac; validate the system for MicroBac's top 10 foods/tests; and finish all other activities required to commercialize the system and testing/analysis service(s). Completing these milestones will establish a new class of multiplexed, component-resolved allergen detection products and food testing services that are expected to improve consumer/public safety, and provide producers an affordable mechanism to comply with zero-tolerance food safety policies.