Development of a Reference Standard to Assign Bacterial Versus Viral Infection Etiology Using an All-inclusive Methodology for Comparison of Novel Diagnostic Tool Performance.

ABSTRACT:

Background

Diagnostic test evaluation requires a reference standard. We describe an approach for creating a reference standard for acute infection using unrestricted adjudication and apply it to compare biomarker tools.

Methods

Adults and children with suspected acute infection enrolled in three prospective studies at emergency departments and urgent cares were included. Adjudicators, blinded to C-reactive protein, procalcitonin, and MeMed BV (MMBV), labeled each case (bacterial/viral/non-infectious/indeterminate). Initial adjudication involved 3 adjudicators. Reference standard cohorts were defined: Microbiologically confirmed (3/3 adjudicators concur with high confidence and a concordant microbiological finding), unanimous (3/3 adjudicators concur with high confidence), su

SUBMITTER: Allen C 

PROVIDER: S-EPMC12043069 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature