一种用于儿童的一步式免疫层析幽门螺杆菌粪便抗原检测方法快速、结果一致、可靠且具有特异性。

A one-step immune-chromatographic Helicobacter pylori stool antigen test for children was quick, consistent, reliable and specific.

作者信息

Kalach Nicolas, Gosset Pierre, Dehecq Eric, Decoster Anne, Georgel Anne-France, Spyckerelle Claire, Papadopoulos Stephanos, Dupont Christophe, Raymond Josette

机构信息

Clinique Pédiatrique St Antoine, Hôpital St Vincent de Paul, Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL), Lille, France.

Service de Gastroentérologie Pédiatrique, Hôpital Necker-Enfants-malades, AP-HP, Université Paris Descartes, Paris, France.

出版信息

Acta Paediatr. 2017 Dec;106(12):2025-2030. doi: 10.1111/apa.13968. Epub 2017 Jul 25.

DOI:10.1111/apa.13968

PMID:28667775

Abstract

AIM

This French study assessed a quick, noninvasive, immuno-chromatographic, Helicobacter pylori (H. pylori) stool antigen test for detecting infections in children.

METHODS

We enrolled 158 children, with a median age of 8.5 years (range eight months to 17 years), with digestive symptoms suggesting upper gastrointestinal tract disease. Upper digestive endoscopy was performed with gastric biopsy specimens for histology, a rapid urease test, culture test and quantitative real-time polymerase chain reaction. The H. pylori stool antigen test was performed twice for each child and the results were compared to the reference method.

RESULTS

The reference methods showed that 23 (14.6%) of the 158 children tested were H. pylori positive. The H. pylori stool antigen test showed 91.3% sensitivity, with a 95% confidence interval (95% CI) of 86.9-95.6 and 97% specificity (95% CI 94.3-99.6), 30.84 positive likelihood ratio and 0.09 negative likelihood ratio. The test accuracy was 96.2% (95% CI 93.2-99.1). The two blinded independent observers produced identical H. pylori stool antigen test results and the Kappa coefficient for the H. pylori stool antigen test was one.

CONCLUSION

The H. pylori stool antigen test was found to be a consistent, reliable, quick and specific test for detecting the H. pylori infection in children.

摘要

目的

这项法国研究评估了一种快速、无创的免疫层析幽门螺杆菌（H. pylori）粪便抗原检测法在检测儿童感染方面的效果。

方法

我们招募了158名儿童，中位年龄为8.5岁（范围为8个月至17岁），这些儿童有提示上消化道疾病的消化症状。对其进行上消化道内镜检查，并取胃活检标本进行组织学检查、快速尿素酶试验、培养试验和定量实时聚合酶链反应。对每个儿童进行两次幽门螺杆菌粪便抗原检测，并将结果与参考方法进行比较。

结果

参考方法显示，158名接受检测的儿童中有23名（14.6%）幽门螺杆菌呈阳性。幽门螺杆菌粪便抗原检测的灵敏度为91.3%，95%置信区间（95%CI）为86.9 - 95.6，特异性为97%（95%CI 94.3 - 99.6），阳性似然比为30.84，阴性似然比为0.09。检测准确性为96.2%（95%CI 93.2 - 99.1）。两名独立的盲法观察者得出的幽门螺杆菌粪便抗原检测结果相同，幽门螺杆菌粪便抗原检测的Kappa系数为1。