Department of Pediatric Gastroenterology, Universidade Federal de São Paulo, Escola Paulista de Medicina (UNIFESP-EPM), São Paulo, Brazil.
J Pediatr Gastroenterol Nutr. 2010 Apr;50(4):400-3. doi: 10.1097/MPG.0b013e3181ac6770.
The monoclonal stool antigen test for diagnosing Helicobacter pylori infection in children has been tested in developed countries, showing sensitivity and specificity higher than 90%. However, its accuracy in young children from developing countries is not well established. The aim of the study was to determine the accuracy of the monoclonal stool antigen test for diagnosing H pylori infection in children up to 7 years old.
Two hundred seventy-six patients (53.6% female; ages 0.35-6.99 years) were evaluated. Gold standard positive culture or positive histology and rapid urease tests were performed. The test (Amplified IDEIATM Hp StAR) was done according to the manufacturer's instructions. Results were expressed as optical density (OD) and an OD more than or equal to 0.190 was considered positive. Additionally, a receiver operating characteristic curve was used to find the best cutoff.
The monoclonal stool antigen test for diagnosing H pylori infection showed 100% sensitivity (95% confidence interval [CI] 92.7%-100%) and 76.2% specificity (95% CI 70.1%-81.4%), considering the manufacturer's cutoff. After setting a new cutoff with the receiver operating characteristic curve (OD = 0.400), sensitivity remained 100% (95% CI 92.7%-100%), but the specificity improved to 97.7% (95% CI 94.7%-99%). At ages up to 2 years, sensitivity was 100% (95% CI 43.8%-100%) and specificity was 100% (95% CI 92.4%-100%); at ages 2 to 4 years, 100% (95% CI 80.6%-100%) and 97.6% (95% CI 96%-99.2%); at ages older than 4 years, 100% (95% CI 88.6%-100%) and 96.6% (95% CI 94.7%-98%), respectively.
The monoclonal stool antigen test is accurate for diagnosing H pylori in children younger than 7 years old, but it must be locally validated in order to find the best cutoff for each population.
检测儿童幽门螺杆菌感染的单克隆粪便抗原检测已在发达国家进行，其敏感性和特异性均高于 90%。然而，其在发展中国家幼儿中的准确性尚未得到充分证实。本研究旨在确定单克隆粪便抗原检测诊断 7 岁以下儿童幽门螺杆菌感染的准确性。
评估了 276 名患者（53.6%为女性；年龄 0.35-6.99 岁）。进行了金标准阳性培养或阳性组织学和快速尿素酶检测。根据制造商的说明进行了检测（Amplified IDEATM Hp StAR）。结果表示为光密度（OD），OD 大于或等于 0.190 被认为是阳性。此外，还使用了接收者操作特性曲线来找到最佳的截断值。
单克隆粪便抗原检测诊断幽门螺杆菌感染的敏感性为 100%（95%置信区间 [CI] 92.7%-100%），特异性为 76.2%（95% CI 70.1%-81.4%），采用制造商的截断值。使用接收者操作特性曲线设定新的截断值（OD=0.400）后，敏感性仍为 100%（95% CI 92.7%-100%），但特异性提高至 97.7%（95% CI 94.7%-99%）。在年龄不超过 2 岁时，敏感性为 100%（95% CI 43.8%-100%），特异性为 100%（95% CI 92.4%-100%）；在 2 至 4 岁时，敏感性为 100%（95% CI 80.6%-100%）和 97.6%（95% CI 96%-99.2%）；在年龄大于 4 岁时，敏感性为 100%（95% CI 88.6%-100%）和 96.6%（95% CI 94.7%-98%）。
单克隆粪便抗原检测对诊断 7 岁以下儿童幽门螺杆菌感染具有较高的准确性，但需要在当地进行验证，以找到每个人群的最佳截断值。
