Sepsis Clinical Trial
Official title:
Prospective, Non-interventional, Multi-centre Clinical Study to Assess the Clinical Validity of the Heparin Binding Protein Assay to Assist in Evaluation of Patients With Suspected Infection Following Emergency Department Admission
To validate the use of the Heparin Binding Protein (HBP) concentration to assist in the evaluation of patients admitting to the emergency department with suspected infection.
Prospective, non-interventional, multi-centre clinical study to assess the clinical validity
of the Heparin Binding Protein (HBP) assay to assist in evaluation of patients with suspected
infection following emergency department admission.
Patients presenting to the emergency department with suspected infection will be enrolled to
the study and have a blood sample taken.
The patients clinical data over a 72 hour period after enrolment will be recorded in the CRF.
The enrolment sample will then be retrospectively measured for the HBP level and the power of
the enrolment HBP level to predict subsequent clinical development over the following 72
hours will be assessed. Data analysis shall include Area Under Curve (AUC) from Receiver
Operating Characteristics (ROC) plot against the patient's final clinical diagnosis as well
as sensitivity and specificity of the HBP level to predict the final clinical outcome.
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