Department of Gastroenterology, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.
Division of Gastroenterology and Hepatology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University; Shanghai Institute of Digestive Disease, Shanghai, China.
Medicine (Baltimore). 2023 Mar 3;102(9):e33107. doi: 10.1097/MD.0000000000033107.
14C-urea breath tests (UBTs) can be used to diagnose helicobacter pylori (H. pylori) infection. This study aimed to evaluate the accuracy of a solid scintillation 14C-UBT in diagnosing H pylori infection. This open-label, prospective multicenter study enrolled patients who underwent H pylori screening from January 7, 2020, to October 28, 2020, in 3 centers in China. All participants underwent solid scintillation UBT first and then gastroscopy. The rapid urease test and histological examination results were the gold standards (H pylori-positive was defined as the 2 tests being positive; H pylori-negative was defined as both tests being negative). The solid scintillation 14C-UBT involves a scintillation sampling bottle and a 14C-urea capsule. The sampling bottle contains a stack of carbon dioxide-absorbing and scintillation sheets. The test is read using a photomultiplier. The sensitivity, specificity, accuracy, positive predictive value, and negative predictive value for H pylori infection were evaluated. This study enrolled 239 participants. There were 98 males and 141 females, aged 45.8 ± 11.9 (range: 21-66) years. Thirty-four participants were excluded due to a discrepancy between the rapid urease test and immunohistochemistry examination. Finally, 205 participants were included in the analysis. According to the gold standard, 87 out of 205 (42.4%) participants were H pylori-positive. Compared with the gold standard, the sensitivity, specificity, accuracy, and positive and negative predictive values of the solid scintillation 14C-UBT were 95.4%, 97.5%, 96.6%, 96.5%, and 96.6% for the solid scintillation UBT, respectively. One participant experienced 1 adverse event (AE) (exacerbation of chronic cholecystitis), and the AE eventually improved by itself. The investigators determined that the AE was unrelated to the study device. The noninvasive solid scintillation 14C-UBT has a high diagnostic value for H pylori infection, comparable to the diagnostic value of the gold standard.
14C-尿素呼气试验（UBT）可用于诊断幽门螺杆菌（H. pylori）感染。本研究旨在评估固体闪烁 14C-UBT 诊断 H pylori 感染的准确性。这是一项开放标签、前瞻性多中心研究，纳入 2020 年 1 月 7 日至 2020 年 10 月 28 日在中国 3 个中心接受 H. pylori 筛查的患者。所有参与者首先接受固体闪烁 14C-UBT，然后进行胃镜检查。快速尿素酶试验和组织学检查结果为金标准（H. pylori 阳性定义为两项检查均为阳性；H. pylori 阴性定义为两项检查均为阴性）。固体闪烁 14C-UBT 涉及闪烁取样瓶和 14C-尿素胶囊。取样瓶中含有一组二氧化碳吸收和闪烁片。使用光电倍增管读取测试结果。评估了 H. pylori 感染的敏感性、特异性、准确性、阳性预测值和阴性预测值。本研究纳入了 239 名参与者。其中男性 98 名，女性 141 名，年龄 45.8±11.9（范围：21-66）岁。由于快速尿素酶试验与免疫组织化学检查结果不一致，34 名参与者被排除。最终，205 名参与者纳入分析。根据金标准，205 名参与者中有 87 名（42.4%）为 H. pylori 阳性。与金标准相比，固体闪烁 14C-UBT 的敏感性、特异性、准确性、阳性预测值和阴性预测值分别为 95.4%、97.5%、96.6%、96.5%和 96.6%。1 名参与者发生 1 例不良事件（AE）（慢性胆囊炎加重），AE 最终自行改善。研究者确定 AE 与研究设备无关。非侵入性固体闪烁 14C-UBT 对 H. pylori 感染具有较高的诊断价值，与金标准的诊断价值相当。
