Detection of viral infection and bacterial co- and superinfection in COVID-19 patients presenting to the emergency department using the 29-mRNA host response classifier BVN-3 – a multicenter study

Abstract Background Identification of bacterial coinfection in COVID-19 patients facilitates appropriate initiation or withholding of antibiotics. The IMX-BVN classifier determines the likelihood of bacterial and viral infections. In a multicenter study, we investigated whether IMX-BVN-3 identifies patients with COVID-19 and bacterial co- or superinfections. Methods PCR-confirmed COVID-19 patients were enrolled in Berlin (Germany), Basel (Switzerland), and Cleveland (both US) upon ED or hospital admission. PAXgene Blood RNA was extracted, and 29 host mRNAs were quantified. BVN-3 categorized patients into Very unlikely, Unlikely, Possible, and Very likely bacterial and viral interpretation bands. BVN-3 results were compared with clinically adjudicated infection status. Results BVN-3 categorized 102 (91.9%) of 111 COVID-19 patients into Very likely or Possible viral bands, 7 (6.3%) into Unlikely, and 2 (1.8%) into Very unlikely viral bands. 93.7% of patients had BVN-3 Unlikely or Very unlikely bacterial results. Among 7 (6.3%) patients with Possible (4) or Very likely (3) bacterial results, 6 (85.7%) had clinically adjudicated bacterial co- or superinfection. Overall, 19 of 111 subjects for whom adjudication was performed had a bacterial infection; 7 of these showed a Very likely or Likely bacterial result in IMX-BVN-3. Conclusions BVN-3 identified COVID patients as virally infected and identified bacterial co- and superinfections. Future studies will determine whether a POC version of the classifier may improve the management of COVID-19 patients including appropriate antibiotic use.