DIAGnosis using NOvel technology for Subtypes In Stroke (DIAGNOSIS study): performance evaluation
Differentiation of intracerebral hemorrhage (ICH) and large vessel occlusion (LVO) from other suspected stroke cases in adult patients presenting with stroke-like symptoms.
This is an observational study with no interventions. The study methodology involves: 1. Collecting clinical features from suspected stroke patients upon hospital arrival, as documented in ambulance and emergency department records. 2. Blood sample collection: - Fingerprick capillary blood sample for the LVOne test. - Venous blood sample (< 4 ml in EDTA tube) for processing and storage. 3. Testing using UpFront Diagnostics' GFAP and D-dimer lateral flow tests (LVOne test), with results available within 15 minutes. 4. Processing of venous blood samples: - Centrifugation and plasma aliquoting within 4 hours of collection - Freezing of plasma at -80°C for later analysis 5. Comparing diagnostic results from the LVOne test and biomarker analyses with final diagnoses determined through clinical evaluation and brain imaging (CT and/or MRI). The study will be conducted at three major stroke centres in Greater Manchester: Salford Royal Hospital, Fairfield General Hospital, and Stepping Hill Hospital. Participants will be followed up prior to hospital discharge to collect information on final diagnosis and treatment.
1. The patient arrived at the study hospital via emergency ambulance. 2. The patient is 18 years of age or older. 3. Ambulance staff suspected a new acute stroke prior to arrival at the hospital. 4. Stroke symptoms began within 6 hours of sample collection (if the onset was not witnessed, the patient was last known to be well less than 6 hours ago). 5. Blood samples can be collected prior to the administration of any treatment. 6. Urgent brain imaging is planned as part of the patient's diagnostic pathway.
1. The patient was assessed at another hospital and transferred for ongoing care. 2. The patient had a recent diagnosis (within the last 4 weeks) of deep vein thrombosis, pulmonary embolism, arterial embolism, stroke, transient ischaemic attack, long bone fracture, major trauma, or surgery under general anaesthesia, as these conditions may increase D-dimer levels. 3. The patient had a recent head injury (within the last 4 weeks) requiring hospital care, as this may increase GFAP levels. 4. Stroke symptoms started more than 6 hours prior to sample collection.