评价两种市售的快速粪便抗原检测试验在幽门螺杆菌感染诊断中的应用。

Evaluation of two commercially available rapid stool antigen tests for the diagnosis of Helicobacter pylori infection.

机构信息

Department of Hepatology, Gastroenterology and Infectious Diseases, Faculty of Medicine, Benha University, Benha, Qalyubiyah, Egypt.

Parasitology, Microbiology and Molecular Biology Department, National Hepatology and Tropical Medicine Research Institute (NHTMRI), General Organization of Teaching Hospitals and Institutes (GOTHI), Cairo, Egypt.

出版信息

J Infect Dev Ctries. 2023 May 31;17(5):631-634. doi: 10.3855/jidc.17525.

DOI:10.3855/jidc.17525

PMID:37279411

Abstract

INTRODUCTION

Helicobacter pylori (H. pylori) is one of the most prevalent infections, which can cause chronic gastritis, peptic ulcers and even gastric cancer. Prompt diagnosis and subsequent eradication are essential. Many commercially available H. pylori stool antigen diagnostic kits are used. However, the diagnostic performance of these tests has not yet been evaluated. This study aimed to evaluate two commercial rapid H. pylori Stool Antigen-Lateral Flow Immunochromatography Assay kits (HpSA-LFIA).

METHODOLOGY

A total of 88 adult patients with dyspeptic symptoms were included in the study. Full case history was obtained, and fresh stool samples were tested for HpSA by two different kits: RightSign® (BiotesT, Hangzhou, China) and OnSite® (CTK biotech, Poway, USA) and HpSA-enzyme-linked immunosorbent assay (ELISA) as a reference standard.

RESULTS

Of the 88 patients, H. pylori infection was positive in 32 (36.4%), negative in 53 (60.2%), and indeterminate in 3 (3.4%) by ELISA. The sensitivity, specificity, positive predictive value, and negative predictive value were as follows: 96.6%, 66.1%, 62%, and 97.4%, respectively for RightSign® test and 96.9%, 50%, 52.5%, and 96.6%, respectively for OnSite® test.

CONCLUSIONS

HpSA-LFIA, RightSign® and OnSite®, are good negative tests, however they cannot be used as a sole test for diagnosis and needs other confirmatory tests in case of positive results.

摘要

简介

幽门螺杆菌（H. pylori）是最常见的感染之一，可导致慢性胃炎、消化性溃疡，甚至胃癌。及时诊断和随后的根除至关重要。有许多市售的幽门螺杆菌粪便抗原诊断试剂盒可供使用。然而，这些检测方法的诊断性能尚未得到评估。本研究旨在评估两种商业上可用的快速幽门螺杆菌粪便抗原-侧向流动免疫层析检测试剂盒（HpSA-LFIA）。

方法

共纳入 88 例有消化不良症状的成年患者。详细采集病史，并使用两种不同的试剂盒（RightSign®[BiotesT，杭州，中国]和 OnSite®[CTK biotech，Poway，美国]）和 HpSA-酶联免疫吸附试验（ELISA）检测新鲜粪便样本中的 HpSA，以作为参考标准。

结果

在 88 例患者中，ELISA 检测结果显示，幽门螺杆菌感染阳性 32 例（36.4%），阴性 53 例（60.2%），不确定 3 例（3.4%）。RightSign®检测的灵敏度、特异性、阳性预测值和阴性预测值分别为 96.6%、66.1%、62%和 97.4%，而 OnSite®检测的灵敏度、特异性、阳性预测值和阴性预测值分别为 96.9%、50%、52.5%和 96.6%。