Evaluation of Universal Biomolecular Medium for Molecular Detection of Respiratory Viruses: A Paired, Multi-Platform Comparison

Résumé fourni par la source

Pre-analytical variables, including specimen transport media, may influence the performance of molecular assays used for respiratory pathogen detection. Universal Biomolecular Medium (UBM™) has been developed to support nucleic acid preservation and molecular testing, but evidence regarding its analytical compatibility with routinely used molecular platforms remains limited. We conducted a retrospective paired comparison of UBM™ against conventional transport and lysis media across multiple molecular platforms to evaluate the post-collection analytical compatibility of UBM. Residual respiratory specimens positive for SARS-CoV-2, influenza A virus, influenza B virus, respiratory syncytial virus, human rhinovirus, human metapneumovirus, Haemophilus influenzae, Mycoplasma pneumoniae, and Bordetella pertussis were analyzed. Paired aliquots generated from the same specimen were tested using the Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay, Xpert® Xpress CoV-2/Flu/RSV plus, Panther Fusion® SARS-CoV-2/Flu A/B/RSV Assay, and selected Allplex™ respiratory panels. Analytical agreement and cycle threshold (Ct) values were compared using paired statistical analyses and Bland–Altman methods. UBM demonstrated complete qualitative concordance with comparator media across all evaluated targets and platforms, yielding 100% positive, negative and overall agreement. Although statistically significant Ct differences were observed for selected target–platform combinations, these shifts were generally small and did not affect qualitative result interpretation. Internal control performance remained stable across media. These findings support the post-collection analytical compatibility of UBM™ with the evaluated molecular workflows.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.