The LIAISON® Legionella Urinary Ag assay: A novel high-throughput, fully automated dual-antigen detection method with improved sensitivity and expanded Legionella species and serogroup coverage

IF 2 Q2 RESPIRATORY SYSTEM

Respiratory investigation Pub Date : 2025-10-03 DOI:10.1016/j.resinv.2025.09.006

Serena Ferraiuolo , Farah Bou Nasser Eddine , Deborah Ferrante , Andrea Dal Corso , Lorenzo Querin , Marco Rigamonti , PierNatale Brusasca , Alfredo Mento , Antonio Savinelli , Karolina Zytko , Massimo Panizzo , Elisa Ghezzi , Clara Rossini , Chiara Mauro , Andrea Pighini , Claudia Zierold , Fabrizio Bonelli , Paolo Ingallinella

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Abstract

Background

Legionella pneumophila is a leading cause of Legionnaires’ disease, with Legionella pneumophila serogroup 1 (Lp1) being the most commonly detected strain. Current urinary antigen tests (UAT) primarily target Lp1, leading to underdiagnosis of non-Lp1 and other Legionella species. A broad-spectrum, fully automated UAT is needed to improve diagnostic accuracy and patient outcomes.

Methods

A novel chemiluminescence immunoassay-based UAT was developed targeting both Legionella peptidoglycan-associated lipoprotein (PAL) and soluble lipopolysaccharide antigen to enable broader detection. Monoclonal antibodies were generated against PAL and integrated into an automated immunoassay platform. The assay's analytical performance was evaluated using recombinant PAL antigens, urine samples spiked with Legionella strains, and clinical specimens. Sensitivity, specificity, cross-reactivity, interference, and precision were assessed.

Results

The LIAISON® Legionella Urinary Ag assay demonstrated a 97.5 % positive agreement and 100 % negative agreement with the Binax™ UAT in detecting Legionella infections. Importantly, the new test also identified multiple non-Lp1 Legionella species, which the comparator assay failed to detect. The assay showed low imprecision, no cross-reactivity or interference.

Conclusions

The LIAISON® Legionella Urinary Ag Assay, a fully automated chemiluminescence-based UAT, provides highly sensitive and specific detection of Legionella infections, including non-Lp1 strains, addressing a major limitation of existing diagnostics. This assay has the potential to improve early detection, guide targeted antibiotic therapy, and enhance public health surveillance of Legionnaires’ disease.

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联络®军团菌尿银测定：一种新型的高通量、全自动双抗原检测方法，具有更高的灵敏度和扩大的军团菌种类和血清组覆盖范围

背景：嗜肺军团菌是军团病的主要病因，其中嗜肺军团菌血清1组（Lp1）是最常检测到的菌株。目前的尿抗原检测（UAT）主要针对Lp1，导致非Lp1和其他军团菌种类的诊断不足。需要一种广谱、全自动的UAT来提高诊断准确性和患者预后。方法建立了一种新的基于化学发光免疫分析的UAT，同时靶向军团菌肽聚糖相关脂蛋白（PAL）和可溶性脂多糖抗原，以扩大检测范围。生成针对PAL的单克隆抗体并整合到自动免疫分析平台中。利用重组PAL抗原、加入军团菌菌株的尿液样本和临床标本对该方法的分析性能进行了评估。评估了灵敏度、特异性、交叉反应性、干扰性和精密度。结果LIAISON®军团菌尿银检测与Binax™UAT检测军团菌感染的阳性率为97.5%，阴性率为100%。重要的是，新的测试还发现了多种非lp1军团菌，这是比较试验未能检测到的。该方法不精密度低，无交叉反应或干扰。结论：LIAISON®军团菌尿银测定是一种全自动的基于化学发光的UAT，可提供高灵敏度和特异性的军团菌感染检测，包括非lp1菌株，解决了现有诊断的主要限制。这种检测方法有可能改善军团病的早期发现，指导靶向抗生素治疗，并加强对军团病的公共卫生监测。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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