Department of Gastroenterology, National Hospital Organization Hakodate National Hospital, Hakodate, Japan.
Department of Internal Medicine, Kawasaki Rinko General Hospital, Kawasaki, Japan.
Helicobacter. 2022 Dec;27(6):e12933. doi: 10.1111/hel.12933. Epub 2022 Oct 20.
Although there are many Helicobacter pylori (H. pylori) diagnostic methods, the culture and antibiotic susceptibility test is an important method for selecting the most effective H. pylori eradication regimen. However, this diagnostic method is complicated and takes several days; therefore, the development of a rapid and simple diagnostic method is required. Eradication failure due to clarithromycin (CAM) resistance should also be considered. In this study, we report the clinical evaluation of point-of-care testing (POCT) kit using intragastric fluid, a novel kit for detecting H. pylori and CAM resistance.
The study participants were 143 patients suspected of H. pylori infection and had an endoscopic examination. The novel diagnostic kit diagnosed H. pylori infection and CAM resistance-associated mutation using intragastric fluid. To diagnose H. pylori infection, the relationship between the diagnostic kit and conventional diagnostic methods (urea breath test, stool antigen test, culture test, and real-time polymerase chain reaction [PCR]) was evaluated. For CAM resistance-associated mutation detection, the concordance between the diagnostic kit and antibiotic susceptibility test was evaluated.
The diagnosis of H. pylori infection with the novel molecular diagnostic kit using intragastric fluid showed significant relationship with conventional diagnostic methods. Especially when the culture was control, the sensitivity was 100% (67/67), the specificity was 95.9% (71/74), and the overall concordance was 97.9% (138/141). The detection of CAM resistance-associated mutations had a concordance rate of 97.0% (65/67) when compared with the antibiotic susceptibility test.
The H. pylori molecular POCT kit uses intragastric fluid as a sample and can diagnose H. pylori infection and detect CAM resistance-associated mutations within an hour. This novel kit is expected to prove useful in selecting the most effective eradication regimen for H. pylori.
尽管有许多幽门螺杆菌（H. pylori）诊断方法，但培养和抗生素药敏试验是选择最有效的 H. pylori 根除方案的重要方法。然而，这种诊断方法较为复杂，需要数天时间；因此，需要开发一种快速简单的诊断方法。还应考虑因克拉霉素（CAM）耐药而导致的根除失败。在本研究中，我们报告了一种使用胃内液的即时检测（POCT）试剂盒的临床评估，这是一种用于检测 H. pylori 和 CAM 耐药相关突变的新型试剂盒。
研究对象为 143 例疑似 H. pylori 感染且接受内镜检查的患者。新型诊断试剂盒使用胃内液诊断 H. pylori 感染和 CAM 耐药相关突变。为了诊断 H. pylori 感染，评估了诊断试剂盒与常规诊断方法（尿素呼气试验、粪便抗原试验、培养试验和实时聚合酶链反应[PCR]）之间的关系。对于 CAM 耐药相关突变的检测，评估了诊断试剂盒与抗生素药敏试验的一致性。
使用胃内液的新型分子诊断试剂盒诊断 H. pylori 感染与常规诊断方法具有显著相关性。特别是当以培养作为对照时，其灵敏度为 100%（67/67），特异性为 95.9%（71/74），总符合率为 97.9%（138/141）。与抗生素药敏试验相比，CAM 耐药相关突变的检测一致性率为 97.0%（65/67）。
H. pylori 分子 POCT 试剂盒使用胃内液作为样本，可在 1 小时内诊断 H. pylori 感染并检测 CAM 耐药相关突变。这种新型试剂盒有望有助于选择最有效的 H. pylori 根除方案。
