2016. TaqMan Multiplex PCR of a Seven-Gene Host Biomarker to Discriminate Bacterial from Viral Infections

Background Acute infections are among the most frequent diagnoses in outpatient care settings. Early, accurate and rapid differentiation between viral and bacterial infections is critical to guide the choice of antimicrobial treatment, improve patient outcome, and to ensure antimicrobial stewardship. Current microbiological offerings rely on direct pathogen detection, which is limited by insufficient accuracy. Recently, host response-based molecular diagnostics have been considered as a novel alternative or complimentary approach. We have previously developed and validated a seven-gene signature set (higher in viral infections (IFI27, JUP, and LAX1) and higher in bacterial infection (HK3, TNIP1, GPAA1, and CTSB) that accurately discriminated between viral and bacterial infections (in six validation cohorts, summary ROC AUC of 0.91 (95% CI, 0.82–0.96). We here describe the development of a rapid multiplex HostDx™ Fever, a seven-gene host response biomarker PCR assay that discriminates bacterial from viral infections.