Non-Invasive Testing device for Anaemia (NITA)

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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.