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oai:figshare.com:article/33950020 2026-09-21T05:36:49Z category_8 portal_316 item_type_3 month_year_09_2026

Data Sheet 1_Inter-platform agreement and diagnostic performance of the automated LIAISON® chemiluminescence immunoassay vs. the Sofia® fluorescence immunoassay for Streptococcus pneumoniae and Legionella pneumophila urinary antigen detection.docx Pablo Pillado (25080535) Alba Llop (25080538) Tessa Katherina Vela (25080541) Asunción Nathaly Ladines (25080544) Montserrat Giménez (310598) Pere-Joan Cardona (189564) Adrián Antuori (16461771) Microbiology chemiluminescence immunoassay community-acquired pneumonia fluorescence immunoassay Legionella pneumophila Streptococcus pneumoniae urinary antigen test Background<p>Urinary antigen tests allow rapid diagnosis of community-acquired pneumonia (CAP) caused by Streptococcus pneumoniae and Legionella pneumophila. We compared the automated LIAISON^® chemiluminescence immunoassay (CLIA) with the Sofia^® fluorescence immunoassay (FIA).</p>Methods<p>This retrospective, single-center study analyzed residual urine from adults with suspected CAP (December 2024–February 2026). The primary analysis compared initial results across both platforms. Our primary endpoint evaluated Cohen's kappa alongside overall, positive, and negative percent agreement (OPA, PPA, NPA). Restricted exclusively to S. pneumoniae, the secondary endpoint assessed diagnostic accuracy against a composite reference standard comprising blood culture, sputum culture, and respiratory PCR. Furthermore, we executed two sensitivity analyses. One incorporated a resolution protocol for initially discordant results. Another restricted the reference standard strictly to culture-confirmed cases. Finally, a Stability cohort (storage ≤ 60 days) was analyzed alongside the Total cohort.</p>Results<p>We analyzed 318 patients in the S. pneumoniae arm and 335 in the L. pneumophila arm. For S. pneumoniae, agreement was substantial (OPA 85.2%, PPA 57.7%, NPA 98.6%, kappa 0.63) and the LIAISON^® assay was less often positive (19.8% vs. 32.7%, p < 0.001). Apparent sensitivity favored the Sofia^® FIA in every comparison, significantly in the primary analysis (Total 77.1% vs. 62.5%, p = 0.039; Stability 86.8% vs. 71.1%, p = 0.031). Neither the secondary analysis nor the post-hoc culture-restricted reference standard altered the direction of any comparison. Under this strict standard, statistical significance persisted exclusively within the Stability cohort prior to discrepancy resolution. For L. pneumophila, agreement was substantial (OPA 93.4%, PPA 66.7%, NPA 98.2%, kappa 0.72), with the LIAISON^® assay again less often positive (11.6% vs. 15.2%, p = 0.017).</p>Conclusion<p>Ultimately, both platforms demonstrated substantial diagnostic agreement across both pathogens. NPA consistently exceeded 98%. However, PPA remained strictly moderate (< 74%). Consequently, the LIAISON^® CLIA yielded fewer positive determinations overall. Regarding S. pneumoniae, this profile drove higher apparent specificity alongside lower apparent sensitivity against our composite reference standard. Crucially, these variances remain inseparable from inherent pre-analytical asymmetries between fresh and frozen-thawed specimens. Simultaneous prospective fresh-specimen clinical evaluations are strictly required.</p> 2026-09-21T05:36:49Z Dataset Dataset 10.3389/fmicb.2026.1926157.s001 https://figshare.com/articles/dataset/Data_Sheet_1_Inter-platform_agreement_and_diagnostic_performance_of_the_automated_LIAISON_chemiluminescence_immunoassay_vs_the_Sofia_fluorescence_immunoassay_for_Streptococcus_pneumoniae_and_Legionella_pneumophila_urinary_antigen_detection_/33950020 CC BY 4.0