DOI 10.3390/microorganisms14081805
Evaluation of Universal Biomolecular Medium for Molecular Detection of Respiratory Viruses: A Paired, Multi-Platform Comparison.
Аннотация
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.
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