NITA

  • Research type

    Research Study

  • Full title

    Non-Invasive Testing device for Anaemia

  • IRAS ID

    331366

  • Contact name

    Paul Leeson

  • Contact email

    paul.leeson@cardiov.ox.ac.uk

  • Sponsor organisation

    University of Oxford

  • Duration of Study in the UK

    2 years, 1 months, 1 days

  • Research summary

    Anaemia arises from a reduction in the number of healthy red blood cells or the level of haemoglobin (Hb) necessary to effectively transport oxygen throughout the body. It is a significant global health concern, affecting 1.6 billion individuals worldwide and untreated anaemia can contribute to chronic heart failure and chronic kidney disease. Anaemia is common among pregnant women. Mild cases of anaemia often go unnoticed due to their nonspecific symptoms, such as fatigue, headaches, and hair loss. Furthermore, studying this disease can be difficult as, particularly in places without ready access to laboratory blood sample analysis as current point-of-care solutions are not able to distinguish between different types of anaemia and prescribe suitable treatments. 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 researching anaemia in a range of settings, including low- and middle-income countries.

    This project is a proof-of-concept study 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. Secondary objectives include identification of other frequently measured blood biomarkers, and identification of biomarkers for long-term health. This study is not collecting data for licensing of the device.

  • REC name

    West of Scotland REC 3

  • REC reference

    24/WS/0122

  • Date of REC Opinion

    4 Sep 2024

  • REC opinion

    Further Information Favourable Opinion