Comparison of two chemiluminescence assays for the detection of Helicobacter pylori antigen in stool samples.

Enfermedades infecciosas y microbiologia clinica (English ed.) Pub Date : 2026-10-21 DOI:10.1016/j.eimce.2026.503313

Alba García-Sáez, Blanca Carrasco, Óscar Cuevas, Juan-Ignacio Alós

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Abstract

Introduction: Non-invasive methods, particularly stool antigen detection, are widely employed for the diagnosis of Helicobacter pylori infection, and the evaluation of new diagnostic platforms is of practical interest. We evaluated the agreement between two chemiluminescence techniques, CLIA LIAISON® H. pylori SA and the recently developed H. pylori Ag VIRCLIA® Monotest.

Methods: We analysed 200 stool samples from patients with suspected infection.

Results: 92 samples were positive and 94 negative in both tests. Of the discordant samples, 9 were positive by LIAISON® and negative by VIRCLIA®, and 5 were positive by VIRCLIA® and negative by LIAISON®. Overall agreement was 93.0%, positive percent agreement (PPA) was 92.9%, and negative percent agreement (NPA) was 93.1%. Kappa coefficient was 0.86 (95% CI 0.79-0.93; p<0.0001).

Conclusions: The VIRCLIA® assay demonstrated a high level of agreement with the LIAISON® assay for the detection of H. pylori stool antigen.

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两种化学发光法检测粪便中幽门螺杆菌抗原的比较。

简介：非侵入性方法，特别是粪便抗原检测，被广泛用于幽门螺杆菌感染的诊断，评估新的诊断平台具有实际意义。我们评估了两种化学发光技术，CLIA LIAISON®h.p ylori SA和最近开发的h.p ylori Ag VIRCLIA®Monotest之间的一致性。方法：对200例疑似感染患者的粪便标本进行分析。结果：两项检测均阳性92例，阴性94例。在不一致的样本中，9例为LIAISON®阳性，VIRCLIA®阴性，5例为VIRCLIA®阳性，LIAISON®阴性。总体协议为93.0%，正面协议（PPA）为92.9%，负面协议（NPA）为93.1%。Kappa系数为0.86 （95% CI 0.79-0.93）。结论：VIRCLIA®检测方法与LIAISON®检测方法在检测幽门螺杆菌粪便抗原方面具有高度的一致性。

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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Enfermedades infecciosas y microbiologia clinica (English ed.)

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