POC-LIT-COV: Point of care test of leukocyte function using LIT to assess and guide COVID patient management
COVID-19 diagnosis can be determined by PCR and lateral flow tests; however this information cannot predict whether an individual will have a severe immune response to COVID-19. For example, two individuals may have the same viral load and one might become severely ill while the other might fight off the disease.
The current criteria for classifying mild and severe cases are mainly based on respiratory rate, oxygen saturation and PaO2/FiO2. Whilst helpful, these measures give no indication of impending intracellular dysfunction and the extent of the multi-system inflammatory processes which is a central feature of severe COVID-19. Neutrophils are the most abundant immune cells in blood and play a crucial role in immune defence against COVID-19. In severe COVID-19 infection neutrophil count typically increases whilst lymphocyte count falls leading to an increase in the neutrophil to lymphocyte ratio. As such an objective marker of neutrophil function in severe COVID-19 patients could represent an important prognostic tool to assess pathogenesis and guide patient management.
Based on technology invented at the University of Oxford UK, Seroxo Ltd is developing the innovative Leukocyte ImmunoTest (LIT) as an in-vitro blood test to quantitatively assess immunocompetence. LIT measures the capacity of leukocytes (primarily neutrophils) to release reactive oxygen species (ROS) using a small drop of blood in a rapid (10 min) near-patient format. LIT is portable (using a handheld luminometer), affordable and its application as a new prognostic parameter to monitor COVID-19 progress, help predict outcome and guide treatment management during acute infection, has already been demonstrated through an initial clinical study led by Prof Paul Moss at the Intensive Care Unit of the QE Hospital Birmingham UK.
The INNO4COVID-19 project funding and its unique support services, will enable a large-scale longitudinal clinical study to be completed and key regulatory steps to be achieved, namely establishing UKCA ‘self-certification’ and progress towards LIT EU IVDR certification.
LIT will not only contribute to COVID-19 management in the EU, but is also well placed (affordable and portable bedside test) to improve COVID-19 management in low- and middle-income countries (i.e. prioritising patients in need of O2 in India).