Evaluation of the diagnostic performance of Neutrocheck® compared with standard-of-care neutrophil and CRP readings in patients at risk of neutropenic sepsis
Neutropenic sepsis
Neutrocheck is a single-use, portable device that accurately detects neutrophil and CRP levels using a blood finger-prick. The device uses lateral flow technology, with innovative housing enabling the measurement of a cell and solute. The device will be used by participants who will measure the line intensity using a visual score card and an automatic reader tool which is available via the companion Neutrocheck app. The participant will watch a video tutorial on how to use the Neutrocheck device. Two research venous blood draws will then be taken. The participant will then use the Neutrocheck device. The participant will take a blood finger prick and insert the blood sample into the device. Once the results are available, the participant will interpret their result using the visual card and by using the companion app. Participants will be asked to complete a questionnaire after using the Neutrocheck device. Patients enrolled from the CAU will use the device once during their CAU visit only, unless they go on to being admitted into a ward, where they will follow the process below for ward patients. Patients enrolled from wards will use the Neutrocheck device daily until they either withdraw from the study, or are discharged home from the hospital. Patients enrolled from routine clinics will use the Neutrocheck device in their regular clinics, which must be 2 weeks apart, for a maximum period of 6 months. There are no follow up or end of trial visits. The NeutroD study is a single visit only study, and the total duration of participant involvement is from informed consent to using the device and completing a questionnaire. No treatment is administered as part of the study.
1. Aged 18 years or over 2. At risk of neutropenia or neutropenic sepsis
1. Evidence of end-organ dysfunction or too unwell to use the Neutrocheck device (e.g systolic blood pressure < 90mmHG) 2. Known HIV or an active Hep B or Hep C infection 3. Bleeding disorder in which a finger prick test is contraindicated 4. Acute Myeloid Leukaemia 5. Significant visual impairment or blindness 6. Participants with significant manual dexterity issues that would prevent them from completing the test