Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: A Retrospective Double Center Field Study, for Validation of Accuracy of a Host-response Based Diagnostics for Distinguishing Between Bacterial and Viral Etiologies in Pediatric Patients With an Acute
Brief Summary:
This is a retrospective external validation study of a novel in-vitro diagnostic (IVD) assay that will include review of medical charts of 4500 pediatric patients to whom ImmunoXpert™ test was taken as part of routine workup for acute febrile illness.
The investigated assay requires the measurement of three host-related, blood-based, protein bio-markers that will be integrated using a formula into a single score.
Based on this score, each patient is classified into one of three categories: (i) bacterial (ii) viral (iii) marginal equivocal immune response (inconclusive or non-infectious).
statistical analysis will be performed to compare ImmunoXpert™ accuracy to current practice lab testing (e.g. WBC, CRP, and PCT) and clinical suspicion at time of requisition. Enrolled patients will be managed according to the current standard of care and per standard institutional procedures.