Jenni Horsma-Heikkinen, Anu Pätäri-Sampo, Tanja Holma, Annika Nevalainen, Nathalie Friberg, Hanna Jarva, Raisa Loginov, Jenni Antikainen
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引用次数: 0
摘要
准确检测幽门螺杆菌及其抗菌药耐药性对于根除感染至关重要。本研究旨在比较五种不同的 CE-IVD 标记检测方法对 268 份临床粪便样本中幽门螺杆菌的检测结果。当五项检测中至少有三项呈阳性时，样本即被视为幽门螺杆菌阳性。Amplified IDEIA Hp StAR (Oxoid) 和 Premier Platinum HpSA PLUS (Meridian Bioscience Inc.) 检测法的灵敏度为 100% [95% CI（置信区间）：87-100]，LIAISON® Meridian H. pylori SA (DiaSorin) 检测法的灵敏度为 83.3%（95% CI：66-93）。检测的特异性分别为 94.5%（95% CI：91-97）、95.4%（95% CI：92-97）和 97.1%（95% CI：94-99）。Amplidiag® 幽门螺杆菌 + ClariR (Mobidiag) 检测法的灵敏度为 93.3% (95% CI: 78-99)，Allplex™ 幽门螺杆菌和 ClariR 检测法 (Seegene Inc.) 的灵敏度为 36.7% (95% CI: 22-55)，两者的特异性均为 97.9% (95% CI: 95-99)。Amplidiag® 和 Allplex™ 检测法能同时检测出幽门螺杆菌阳性样本对克拉霉素的耐药性。Amplidiag® 检测法的准确率最高，达到 97.4%（95% CI：95-99）。这些数据为制定幽门螺杆菌实验室诊断计划和从粪便样本中检测克拉霉素耐药性提供了有用的信息。
Evaluation of five different methods for diagnosis of Helicobacter pylori from fecal samples.
Accurate detection of Helicobacter pylori and its antimicrobial resistance is essential for eradication of the infections. The aim of this study was to compare five different CE-IVD marked assays in detection of H. pylori from 268 clinical stool samples. Samples were considered positive for H. pylori when at least three of the five tests were positive. Amplified IDEIA Hp StAR (Oxoid) and Premier Platinum HpSA PLUS (Meridian Bioscience Inc.) assays showed sensitivity of 100% [95% CI (confidence interval): 87-100] and LIAISON® Meridian H. pylori SA (DiaSorin) of 83.3% (95% CI: 66-93). Specificities of the assays were 94.5% (95% CI: 91-97), 95.4%; (95% CI: 92-97), and 97.1% (95% CI: 94-99) respectively. Amplidiag® H. pylori + ClariR (Mobidiag) assay showed 93.3% (95% CI: 78-99) and Allplex™ H. pylori & ClariR Assay (Seegene Inc.) 36.7% (95% CI: 22-55) sensitivity, while specificity of both was 97.9% (95% CI: 95-99). The Amplidiag® and Allplex™ assays concordantly detected clarithromycin resistance in positive for H. pylori samples. The Amplidiag® assay showed the highest accuracy, namely 97.4% (95% CI: 95-99). These data provide helpful information for planning laboratory diagnostics of H. pylori and detection of clarithromycin resistance from stool samples.
期刊介绍：
APMIS, formerly Acta Pathologica, Microbiologica et Immunologica Scandinavica, has been published since 1924 by the Scandinavian Societies for Medical Microbiology and Pathology as a non-profit-making scientific journal.
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