Non-Invasive Testing device for Anaemia (NITA)

贫血是由于健康的红血球数量的减少或体内有效输送氧气所需的血红蛋白水平的降低而引起的。这是一个重大的全球健康问题，全世界有16亿人感染。轻微的贫血症由于其非特异性症状，如疲倦、头痛和脱发，通常不被注意到。然而，及时诊断和解决这种情况是至关重要的，因为未经治疗的贫血可能会导致慢性心力衰竭和慢性肾脏疾病。不幸的是，目前的护理解决方案不能区分不同类型的贫血并开出合适的治疗方案。因此，贫血诊断的黄金标准仍然依赖于实验室血液测试，这在护理点能力、可及性以及与分析标准化差和样本质量低有关的偏差方面存在局限性。我们开发了一种便携式和用户友好的设备，能够快速、非侵入性地检测贫血，并通过区分缺铁性贫血和其他原因而促进适当的治疗。我们的设备名为耳廓血管成像工具(VITA)，利用高分辨率成像技术捕获人体内血细胞和小血管的详细图像。与现有的非侵入性设备只能测量大量组织样本的特性不同，VITA可以分析数百个单个细胞的特征，从而促进缺铁性贫血的快速护理点测试。VITA是一种低成本设备，其独特的无需耗材或训练有素的操作员即可测量这些参数的能力使其特别适合于解决低收入和中等收入国家的贫血问题。我们的市场研究强调了临床上迫切需要一种更方便的诊断贫血的方法，这种方法不需要受过医学培训的人员或实验室。VITA的指标，如平均红细胞血红蛋白和平均红细胞体积，在临床使用时得到了医务人员的高度接受。VITA检测红细胞形态特征的能力使其相对于目前用于贫血检测的现有非侵入性设备具有明显的技术优势，但与最终用户的对话和与潜在投资者的初步讨论表明，验证数据对于商业化进程至关重要。正在进行的临床研究通过以人为中心的方法开发了注重可用性的设备，并为验证VITA的微血管成像性能提供了宝贵的数据。然而，他们没有提供必要的血液测试数据来验证其在贫血方面的应用。因此，该奖项的目的是评估VITA在Hb检测方面的表现，以及它对照实验室血液检测的临床黄金标准识别缺铁性贫血的能力。我们计划通过优化我们专门针对贫血的现有设备，开发能够从采集的图像中自动提取相关红细胞参数的定制图像分析软件，并进行临床验证研究来实现这一目标。通过使这种高度流行的疾病能够更容易、更轻松地进行监测，我们的创新有可能显著减轻当前与贫血相关的健康和经济负担，特别是对受影响不成比例的妇女和儿童。此外，它还有能力改变目前无法获得实验室检测的个人的医疗保健。

Anaemia arises from a reduction in the number of healthy red blood cells or the level of haemoglobin necessary to e!ectively transport oxygen throughout the body. It is a significant global health concern, a!ecting 1.6 billion individuals worldwide. Mild cases of anaemia often go unnoticed due to their nonspecific symptoms, such as fatigue, headaches, and hair loss. However, it is crucial to diagnose and address this condition promptly, as untreated anaemia can contribute to chronic heart failure and chronic kidney disease. Unfortunately, current point-of-care solutions are not able to distinguish between di!erent types of anaemia and prescribe suitable treatments. As a result, the gold standard for anaemia diagnosis still relies on laboratory blood tests, which come with limitations in terms of point-of-care capability, accessibility, and biases related to poor standardisation of assays and low sample quality.We have developed a portable and user-friendly device capable of detecting anaemia rapidly and non-invasively and facilitating appropriate treatment by distinguishing anaemia due to iron deficiency from other causes. Our device, named The Vascular Imaging Tool for the Auricle (VITA), utilises high-resolution imaging technology to capture detailed images of blood cells and small vessels within the human body. Unlike existing non-invasive devices that can only measure properties in bulk tissue samples, VITA can analyse characteristics of hundreds of individual cells, thereby facilitating rapid point-of-care testing for iron deficiency anaemia. VITA is a low-cost device, and its unique ability to measure these parameters without requiring consumables or trained operators makes it particularly well-suited for addressing anaemia in low- and middle-income countries.Our market research highlighted a pressing clinical need for a more convenient method of diagnosing anaemia, one that does not rely on medically trained personnel or laboratories. VITA's metrics such as mean corpuscular haemoglobin and mean corpuscular volume have high acceptance with medical staff as they are clinically used. VITA's capability to detect morphological features of red blood cells gives it a clear technical advantage over existing non-invasive devices currently employed for anaemia detection, but conversations with end users and preliminary discussions with potential investors revealed that validation data is crucial for progression towards commercialisation.Ongoing clinical studies have informed our device development through a human-centred approach with a focus on usability and have provided valuable data to validate VITA's microvascular imaging performance. However, they do not supply the necessary blood test data to validate its applications in anaemia. Hence, the objectives of this award are to assess VITA's performance of Hb testing and its ability to identify iron deficiency anaemia against the clinical gold standard of laboratory blood tests. We plan to achieve this by optimising our existing device specifically for anaemia, developing customised image analysis software capable of automatically extracting the relevant red blood cell parameters from the acquired images, and conducting a clinical validation study.By enabling more accessible and less burdensome monitoring of this highly prevalent disease, our innovation has the potential to significantly reduce the current health and economic burdens associated with anaemia, particularly for women and children who are disproportionately affected. Furthermore, it has the power to transform healthcare for individuals who currently lack access to laboratory tests.