Evaluation of the Clinical and Analytical Performance of the LIAISON PLEX for the Qualitative Detection of Human Adenovirus in Respiratory Samples

Human adenoviruses (HAdVs) are significant causes of respiratory infections, which are most commonly associated with species B, C, and E. Certain adenovirus types, including 4, 5, 14, 21, 55, and 66, are associated with higher mortality and outbreaks of severe respiratory disease in both civilian and military populations. Laboratory diagnosis of HAdV respiratory infections has largely relied on extended respiratory pathogen panels; however, the comparative analytical and clinical performance of commonly used panels for HAdV detection remains largely unknown. In this study, we compared the LIAISON PLEX® Respiratory Flex Assay (RSP Flex ) and the BioFire® RP2.1 panels for the detection of HAdV in respiratory samples. Sixteen HAdV genotypes were tested in replicate using both panels. In addition, 116 retrospective and prospective nasopharyngeal swab specimens were tested in parallel using both assays. The two panels demonstrated equivalent analytical sensitivity, with an average limit of detection of approximately 250 copies/mL across all tested genotypes. All 56 samples positive by the BioFire RP2.1 were also positive by the RSP Flex (sensitivity 100%; 95% CI, 63.62%–100%). One sample negative by the BioFire RP2.1 tested positive with the RSP Flex (specificity 98.25%; 95% CI, 90.61%–99.96%) and was confirmed positive by discordant testing. These data confirm the excellent analytical and clinical performance of the RSP Flex Assay for HAdV detection across multiple genotypes and a wide range of viral loads when compared to the BioFire® RP2.1, supporting its reliability for HAdV clinical respiratory testing. • The RSP Flex panel demonstrated sensitivity and genotype inclusivity comparable to the BioFire RP2.1 across 16 respiratory HAdV genotypes. • Excellent clinical agreement was observed between the two syndromic respiratory panels for HAdV detection. • Rigorous assay validation is essential for reliable HAdV diagnosis given low-level circulation, genotype diversity, and limited utility of trend-based quality monitoring.