A 29-mRNA host response test to identify bacterial and viral infections and to predict 30-day mortality in emergency department patients with suspected infections: A prospective observational cohort study

Introduction: The goal of this study is to validate the accuracy of the 29-mRNA host response classifiers Inflammatix Bacterial-Viral-Non infected-3b (IMX-BVN-3b) and Severity-3b (IMX-SEV-3b) to identify bacterial and viral infections and to predict 30-day mortality in patients with suspected infections in the ED. Methods: This prospective observational cohort study enrolled patients with suspected infections in a tertiary ED. IMX-BVN-3b was compared to clinically forced and consensus adjudicated bacterial/viral infection status and IMX-SEV-3b was compared to 30-day mortality. Results: A total of 688 patients were enrolled. Using forced adjudication, the AUC for the diagnosis of bacterial infection by IMX-BVN-3b was 0.76 (95 % CI: 0.72 – 0.80). The AUC for the diagnosis of viral infections was 0.89 (95 %CI 0.84-0.95). IMX-SEV-3b had an AUC of 0.77 (95 % CI: 0.68 – 0.85) on 30-day mortality. Conclusion: The 29-gene host response classifiers IMX-BVN-3b and IMX-SEV-3b identify viral and bacterial infections and predict 30-day mortality in patients with suspected infections in the ED.