The Headstart Test system is an in vitro diagnostic test intended for self-testing for the detection of five biomarkers of infection in the urine of patients diagnosed with chronic obstructive pulmonary disease (COPD). Patient urine testing will be conducted daily to establish a patient baseline biomarker profile and provide ongoing monitoring for changes in the biomarker profile. Headstart results will be used as an aid in monitoring and early detection of pulmonary exacerbation.
Patients will be asked to collect and test a daily urine sample using a novel testing system (HeadStart Test system) in addition to answering questions abut their daily COPD symptoms for 6 months. In summary, this study aims to validate a novel non-invasive point of care (near-patient) testing system, to allow people with COPD to detect pulmonary exacerbations by measuring urinary biomarkers. If successful, we hope that this will provide patients with an easy to use device, which will empower patients and their caregivers to treat exacerbations at an earlier stage, with potential health and economic benefits.
Study Type
OBSERVATIONAL
Enrollment
86
Institute for Lung Health, Glenfield Hospital
Leicester, Leicestershire, United Kingdom
Headstart IVD performance
To determine whether the Headstart Test system can accurately diagnose an acute exacerbation of COPD prior to the onset of a clinically confirmed event. (Defined as need for antibiotics and/or Oral Corticosteroids (OCS) and/or attendance to hospital (GOLD 2019).
Time frame: 6 months
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