Non-Invasive Testing device for Anaemia (NITA)

贫血是由健康红细胞数量减少或血红蛋白水平降低引起的。有效地将氧气输送到全身。这是一个重大的全球卫生问题。全世界有16亿人。轻度贫血的病例往往因其非特异性症状而被忽视，如疲劳、头痛和脱发。然而，及时诊断和治疗这种疾病至关重要，因为未经治疗的贫血会导致慢性心力衰竭和慢性肾脏疾病。不幸的是，目前的即时护理解决方案无法区分di！事件类型的贫血和规定适当的治疗。因此，贫血诊断的金标准仍然依赖于实验室血液检测，这在护理点能力、可及性以及与检测标准化程度低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、用户友好的设备，能够快速、无创地检测贫血，并通过区分缺铁和其他原因导致的贫血，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捉人体内血细胞和小血管的详细图像。与现有的只能测量大量组织样本的非侵入性设备不同，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即时检测。VITA是一种低成本设备，其测量这些参数的独特能力不需要耗材或训练有素的操作人员，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，临床迫切需要一种更方便的诊断贫血的方法，这种方法不依赖于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，医务人员的接受度很高。VITA检测红细胞形态特征的能力使其比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以及与潜在投资者的初步讨论表明，验证数据对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，关注可用性，为我们的设备开发提供了信息，并提供了有价值的数据来验证VITA的微血管成像性能。然而，他们没有提供必要的血液检测数据来验证其在贫血中的应用。因此，该奖项的目的是评估VITA在Hb检测方面的表现，以及根据实验室血液检测的临床金标准识别缺铁性贫血的能力。我们计划通过优化现有设备来实现这一目标，该设备专门用于贫血，开发定制的图像分析软件，能够从获取的图像中自动提取相关红细胞参数，并进行临床验证研究。通过使对这一高度流行疾病的监测更容易获得和负担更轻，我们的创新有可能大大减轻目前与贫血有关的健康和经济负担，特别是对受到严重影响的妇女和儿童。此外，它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.