STAT Palm-Sized Blood Counter

 描述（由申请人提供）：本提案的总体目标是获得FDA 5 - 10（k）提交的数据，即手持式小型STAT血液计数器使用5-10 µL血液进行全血细胞计数（CBC）和三部分分类计数。这种显著减小的尺寸和样本量为这些血液学检测的交付创造了新的机会，最终导致更简化，可用和按需护理。在第一阶段，我们展示了用于血液稀释的微流体方法的概念验证，开发了微型流式细胞仪模块，并展示了血液的阻抗测量。在第二阶段，我们开发了一种微量样品耗材，在螺旋涡旋式微混合器中演示了血液稀释，使我们的微型光学模块的性能达到了与大型血细胞仪相当的水平，并开发了我们的血液传感器的概念模型。在IIB阶段，我们计划全面设计STAT血液计数器的产品版本，并在波士顿儿童医院进行验证。我们建议大部分产品开发将在第1-2年进行，验证和提交将在第3年进行。在工作结束时，我们将提交我们的技术，以获得FDA 510（k）批准，用于CBC和3部分分类。这将使测量失血，感染和出血风险的能力在一系列不同的设置，包括诊所，急诊室，救护车，发展中国家和外地。

 DESCRIPTION (provided by applicant): The overarching objective of this proposal is to attain data for FDA 510(k) submission of a handheld miniaturized STAT Blood Counter using 5-10 µL blood to yield a complete blood count (CBC) with 3-part differential. This dramatically decreased size and sample volume creates new opportunities in delivery of these hematology tests, ultimately leading to more streamlined, available, and on demand care. In Phase I, we showed proof-of-concept for our microfluidic approach for blood dilution, developed a miniature flow cytometry module, and demonstrated impedance measurements of blood. In Phase II, we developed a microvolume sample consumable, demonstrated blood dilution in our spiral vortexer micromixer, brought our miniature optical block's performance up to par with larger cytometers, and developed a concept model of our blood sensor. Here in this Phase IIB, we plan to fully engineer a product version of our STAT Blood Counter and validate it at Boston Children's Hospital. We are proposing that most of the product development will occur in Years 1-2 and the validation and submission in Year 3. At the conclusion of the effort, we will have submitted our technology for FDA 510(k) approval for CBC with 3-part differential. This will enable capabilities for measuring blood loss, infection, and bleeding risk in a range of different settings including the clinic, emergency rooms, ambulances, developing countries, and the field.