FebriDx® Pediatric Validation Study

The primary objective of this study is to determine performance characteristics of the FebriDx® test in differentiating bacterial from non-bacterial etiology among febrile pediatric patients (2-11 years) presenting to the emergency department, urgent care center or primary care office with a suspected acute respiratory tract infection.

This is a prospective, multi-center, observational, blinded study where children with suspected acute respiratory infection will undergo FebriDx® testing. The primary outcome is the presence of a bacterial associated systemic host immune response related to a febrile acute respiratory tract infection, as compared to the reference standard of clinical adjudication as determined by a panel of pediatric experts using the Clinical Reference Algorithm that includes pathogen detection testing (e.g., bacterial culture, multiplex PCR) as well as measures of host immune response. FebriDx is a rapid lateral flow immunoassay for the visual, qualitative, in vitro detection of elevated levels of host response proteins, Myxovirus resistance protein A (MxA) and C-reactive protein (CRP), directly from fingerstick blood.