Multicenter evaluation of the QIAstat-Dx® Respiratory Panel V2 for the detection of viral and bacterial respiratory pathogens.

The QIAstat-Dx® Respiratory Panel V2 (RP) is a novel molecular-based syndromic test for the simultaneous and rapid (∼70 minutes) detection of 18 viral and three bacterial pathogens causing respiratory infections. This study describes the first multicenter retrospective comparison of the performance of the QIAstat-Dx® RP assay to the established ePlex® Respiratory Pathogen Panel (RPP) assay, for which we used 287 respiratory samples from patients suspected with respiratory infections. The QIAstat-Dx® RP assay detected 312 of the 338 respiratory targets (92%) that were detected by the ePlex® RPP assay. Most discrepant results have been observed in the low pathogen load samples. In addition, the QIAstat-Dx® RP assay detected 19 additional targets in 19 respiratory samples that were not detect by the ePlex® RPP assay. Nine of these discordant targets were considered to be true positives after discrepancy testing by a third method. The main advantage of the QIAstat-Dx® system compared to other syndromic testing systems, including the ePlex® RPP assay, is the ability to generate CT values that could help with the interpretation of results. Taken together, this study shows a good performance of the QIAstat-Dx® RP assay in comparison to the ePlex® RPP assay for the detection of respiratory pathogens. The QIAstat-Dx® RP assay offers a new, rapid, and accurate sample-to-answer multiplex panel for the detection of the most common viral and bacterial respiratory pathogens and therefore has the potential to direct appropriate therapy and infection control precautions.