Evaluation of the Seegene Allplex™ Respiratory Panel for diagnosis of acute respiratory tract infections

<p><b>Objectives:</b> The Seegene Allplex<sup>TM</sup> Respiratory panel was retrospectively challenged using a collection of quality control samples (QCMD) and clinical samples previously analysed with validated routine methods.</p> <p><b>Methods:</b> A collection of 111 samples [43 QCMD samples, 13 bronchoalveolar lavage fluids and 55 nasopharyngeal aspirates/swabs] was tested with Seegene Allplex<sup>TM</sup>. The clinical samples were tested previously using either FTD® Respiratory Pathogens 21 qPCR assay (Fast Track Diagnostics), an in-house multiplex PCR for <i>Bordetella</i>, or BioGX Sample-Ready<sup>TM</sup> Atypical pneumo panel (Becton Dickinson). Samples were stored at −80°C prior to analysis with Seegene Allplex™, nucleic acids were automatically extracted with NucliSENS Easymag (bioMérieux). Samples returning discordant results were subjected to repeat testing and/or additional testing by reference laboratories.</p> <p><b>Results:</b> Seegene correctly identified 41/43 QCMD samples (95.4%); two samples positive for respiratory syncytial virus (RSV) and human metapneumovirus, respectively, were only correctly identified following repeat testing. In the 56 clinical samples, overall, 97 pathogens were identified: 65 pathogens (67.0%) were detected both by routine methods and Seegene, 24 pathogens (24.7%) only by routine methods, and 8 pathogens (8.2%) only by Seegene. The majority of discordant results was detected in samples with low pathogen load (22/32, 68.8%) and in samples containing multiple pathogens (25/32, 78.1%). Full agreement between methods was observed for influenza, RSV, adenovirus, <i>Bordetella (para)pertussis</i> and <i>Chlamydia</i> <i>pneumoniae</i>. Discordance was observed for human metapneumovirus, coronavirus OC43, bocavirus and parainfluenza virus, mainly type 4. </p> <p><b>Conclusion:</b> Overall, the Seegene Allplex<sup>TM</sup> assay performed well for routine detection of important respiratory targets. Acceptable agreement was observed between Seegene and other routine assays.</p>