Non-Invasive Testing device for Anaemia (NITA)

非侵入性贫血检测设备 (NITA)

• 批准号: MR/Y503356/1
• 负责人: Winok Lapidaire
• 金额: $ 21.71万
• 依托单位: University of Oxford
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2024
• 资助国家: 英国
• 起止时间: 2024 至 无数据
• 项目状态: 未结题
• 来源: https://gtr.ukri.org/projects?ref=MR%2FY503356%2F1
• 关键词: Non; Invasive; Testing; device; Anaemia

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.

贫血是由健康的红细胞数量减少或在整个体内运输氧气所需的血红蛋白水平。这是全球重大的健康问题，全球16亿个人。轻度贫血病例通常由于其非特异性症状（例如疲劳，头痛和脱发）而引起人们的注意。但是，及时诊断和解决这种疾病至关重要，因为未经治疗的贫血可以导致慢性心力衰竭和慢性肾脏疾病。不幸的是，当前的护理解决方案无法区分贫血类型的贫血和开处方适当的治疗方法。结果，贫血诊断的黄金标准仍然依赖于实验室血液测试，这在护理能力，可及性和与不良标准化和低样本质量相关的偏见方面受到限制。我们开发了一种便携式和用户友好的设备，能够通过迅速进行炎症和不适合锻炼的态度来检测贫血症状，以使其与其他适当的治疗相处。我们的设备被称为耳膜（VITA）的血管成像工具，利用高分辨率成像技术来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不同，只能测量整体组织样品中的性质，VITA可以分析数百个单个细胞的特征，从而促进铁缺乏症贫血的快速护理测试。 VITA是一种低成本的设备，它在不需要消耗品或受过训练的操作员的情况下测量这些参数的独特能力使其特别适合解决低收入和中等收入国家 /地区的贫血。我们的市场研究突出了一种紧迫的临床需求，对诊断贫血的更方便的诊断方法不依赖医疗培训培训的贫血方法。 Vita的指标，例如平均红细胞血红蛋白和平均红细胞量的指标，在​​临床上使用的医务人员接受了很高的接受。 Vita检测红细胞形态特征的能力使其与目前用于贫血检测的现有非侵入性设备相比具有明显的技术优势，但是与最终用户的对话和与潜在投资者进行的初步讨论，验证数据揭示了对商业化的临床发展，并为我们的设备开发了人类的范围，并在人体上提供了人体范围的范围，并在人体上提供了众多的范围，并已为人们提供了人类的范围，并已为人们提供了范围的范围，并在人体中介绍了众多的范围，并遍及了人类风格的范围。成像性能。但是，他们没有提供必要的血液测试数据来验证其在贫血中的应用。因此，该奖项的目标是评估VITA的HB测试表现及其鉴定铁缺乏症贫血的能力，以针对实验室血液测试的临床黄金标准。我们计划通过专门针对贫血的现有设备进行优化，开发能够自动从获得的图像中提取相关的红细胞参数的定制图像分析软件，并进行临床验证研究。通过使我们对这种高度普遍的疾病的监测更加易于访问且较小的监测，我们的创新与当前的健康和经济相关，这些疾病的潜力与当前的健康相关，这些疾病与经济局长相关，这些疾病的可能性是相关的。 做作的。此外，它有能力为目前缺乏实验室测试的个人转变医疗保健。