A Rapid Host Response Blood Test for Bacterial/Viral Infection Discrimination Using a Portable Molecular Diagnostic Platform.

BACKGROUND: Difficulty discriminating bacterial versus viral etiologies of infection drives unwarranted antibacterial prescriptions and, therefore, antibacterial resistance. METHODS: Utilizing a rapid portable test that measures peripheral blood host gene expression to discriminate bacterial and viral etiologies of infection (the HR-B/V assay on Biomeme's polymerase chain reaction-based Franklin platform), we tested 3 cohorts of subjects with suspected infection: the HR-B/V training cohort, the HR-B/V technical correlation cohort, and a coronavirus disease 2019 cohort. RESULTS: The Biomeme HR-B/V test showed very good performance at discriminating bacterial and viral infections, with a bacterial model accuracy of 84.5% (95% confidence interval [CI], 80.8%-87.5%), positive percent agreement (PPA) of 88.5% (95% CI, 81.3%-93.2%), negative percent agreement (NPA) of 83.1% (95% CI, 78.7%-86.7%), positive predictive value of 64.1% (95% CI, 56.3%-71.2%), and negative predictive value of 95.5% (95% CI, 92.4%-97.3%). The test showed excellent agreement with a previously developed BioFire HR-B/V test, with 100% (95% CI, 85.7%-100.0%) PPA and 94.9% (95% CI, 86.1%-98.3%) NPA for bacterial infection, and 100% (95% CI, 93.9%-100.0%) PPA and 100% (95% CI, 85.7%-100.0%) NPA for viral infection. Among subjects with acute severe acute respiratory syndrome coronavirus 2 infection of ≤7 days, accuracy was 93.3% (95% CI, 78.7%-98.2%) for 30 outpatients and 75.9% (95% CI, 57.9%-87.8%) for 29 inpatients. CONCLUSIONS: The Biomeme HR-B/V test is a rapid, portable test with high performance at identifying patients unlikely to have bacterial infection, offering a promising antibiotic stewardship strategy that could be deployed as a portable, laboratory-based test.

Duke Scholars

Author Micah Thomas McClain Medicine, Infectious Diseases

Author Geoffrey Steven Ginsburg Medicine, Cardiology

Author Christopher Wildrick Woods Medicine, Infectious Diseases

Author Gayani Tillekeratne Medicine, Infectious Diseases

Author Ricardo Henao Biostatistics & Bioinformatics, Division of Translational Bi ...