Novel devices for rapid blood compatibility testing

描述(由申请人提供)：这是一项修订后的STTR第二阶段竞争延续申请，允许3Ti生产第二代版本的全自动血库多分析仪(3Ti Aegis)；在多中心临床试验中评估Aegis；并提交FDA 510(K)申请。Aegis通过以前的STTR支持开发，可通过无需操作的自动化进行快速、准确且经济实惠的血型鉴定和其他输血前检测。利用第一阶段的资金，我们最初开发了一种强大的荧光细胞仪血型鉴定技术。在第二阶段，我们利用这项工作制造了一个全自动原型(第一代)，在内部临床试验中进行了彻底的测试。这些评估显示了宙斯盾相对于领先的商业可用系统的3个显著优势。首先，也是最重要的是，宙斯盾进行血型鉴定的临床准确性高于竞争对手的技术。其次，成本分析表明，这种工具的操作成本要低得多。第三，因为我们的系统是用多功能架构开发的，我们还展示了(通过单独的第一阶段STTR资助)可以很容易地配置它来执行以前没有自动化过的分析，包括计算血液成分过滤后残留的WBC和检测捐赠者血浆中的抗人类白细胞抗原抗体(以防止TRALI)。虽然我们相信宙斯盾设备的优势将使其在血液行业具有很强的商业竞争力，但本申请中提出的工作对于使3Ti能够追求并获得所需的FDA 510k上市前批准至关重要。具体目标如下：1)制造2台第二代Aegis工作站，并完成Aegis操作软件和试剂的开发和验证；2)执行经FDA批准设计的多中心临床试验；以及3)评估临床试验结果，并将其纳入可行的FDA 510(K)提交文件，目的是展示与预测性设备的实质等价性，并获得将Aegis推向市场的批准。公共健康研究进展：对公共健康的影响和相关性：红细胞输注代表了贫血患者的救命疗法。在输血之前，必须确定受血者和捐献者的血型，并进行交叉配型，以确保配型。3Ti Aegis是一种完全自动化的血液分型工作站，与当前的方法相比具有显著的优势。我们预计，宙斯盾的商业化将减少不相容输血的发生率，从而改善输血结果和患者安全。

DESCRIPTION (provided by applicant): This is a revised STTR Phase II Competing Continuation application to allow 3Ti to: produce a second- generation version of a fully-automated blood bank multianalyzer (the 3Ti AEGIS); evaluate the AEGIS in multicenter clinical trials; and submit an FDA 510(k) application. Developed through previous STTR support, the AEGIS performs rapid, accurate, and cost-effective blood typing and other pretransfusion testing with walk-away automation. Using Phase I funding, we initially developed a robust technology for blood typing by fluorescence cytometry. In Phase II, we leveraged this work to fabricate a fully-automated prototype (first-generation) which was thoroughly tested during in-house clinical trials. These evaluations demonstrated 3 significant advantages of the AEGIS over leading commercially available systems. First, and most importantly, the AEGIS performed blood typing with better clinical accuracy than competing technologies. Second, cost analysis demonstrated that this instrument was significantly less expensive to operate. Third, because our system was developed with a multifunctional architecture, we also showed (through separate Phase I STTR funding) that it could be readily configured to perform assays that have not previously been automated including counting residual WBCs after filtration of blood components and detecting anti-HLA antibodies in donor plasma (to prevent TRALI). While we believe that the advantages of the AEGIS device will make it very commercially competitive in the blood industry, the work proposed in this application is vital in order to allow 3Ti to pursue and obtain the required FDA 510k premarket approval. The Specific Aims are as follows: 1) To fabricate 2 second-generation AEGIS workstations, and complete development and validation of AEGIS operating software and reagents; 2) To perform multicenter clinical trials designed with FDA approval; and 3) To evaluate and incorporate the results of the clinical trials into a viable FDA 510(k) submission, with the objective of demonstrating substantial equivalence to predicate devices and obtaining approval to bring AEGIS to market. PULIC HEALTH RELEVENCE: Implications and relevance to public health: Red blood cell transfusions represent lifesaving therapies for anemic patients. Prior to transfusion, recipient and donor blood type must be determined, and crossmatching performed, to ensure compatibility. The 3Ti AEGIS is a completely automated blood typing workstation with significant advantages over current methodologies. We anticipate that commercialization of the AEGIS will reduce the incidence of incompatible transfusions and thus improve transfusion outcomes and patient safety.