Konya Education and Research Hospital, Microbiology Laboratory, Yeniyol, Meram, Konya, Turkey.
J Investig Med. 2010 Dec;58(8):982-6. doi: 10.231/JIM.0b013e3181f31569.
The aim of the study was to compare 3 stool antigen tests for diagnosis of Helicobacter pylori infection in adult patients with dyspeptic complaints before eradication therapy. We compared 2 enzyme immunoassays (EIAs: Premier Platinum Helicobacter pylori Stool Antigen [HpSA] Plus and Helicobacter pylori Antigen [Hp Ag]) and one immunochromatographic assay (H. pylori fecal antigen test-lateral-flow chromatography) in detecting H. pylori. All the investigated stool antigen tests were made of monoclonal antibodies. We evaluated 168 adult patients with H. pylori infection by using 2 criterion standard methods (histological and rapid urease tests) together. The sensitivity and specificity were 90% and 91%, respectively, for the Premier Platinum HpSA Plus, 77% and 91%, respectively, for the Hp Ag, and 81% and 92%, respectively, for the H. pylori fecal antigen test, respectively. The best agreement between the criterion standard tests and the stool antigen tests used in the study was with the Premier Platinum HpSA Plus. Immunochromatographic assay-based stool antigen test (H. pylori fecal antigen test) was found to be more sensitive than the EIA-based test (Hp Ag). One of the 2 important conclusions obtained from the study was that the Premier Platinum HpSA Plus was found to be the most accurate test for the diagnosis of H. pylori infection in adult dyspeptic patients before eradication therapy, and the other was that monoclonal and high-quality, reliable immunochromatographic assay tests are a good option especially for small hospital laboratories that do not have appropriate equipment for performing the EIA and working on few samples.
本研究旨在比较三种粪便抗原检测方法在根除治疗前诊断消化不良成年患者幽门螺杆菌感染的效果。我们比较了两种酶联免疫吸附试验(EIAs:Premier Platinum 幽门螺杆菌粪便抗原检测试剂盒[HpSA Plus]和幽门螺杆菌抗原[Hp Ag])和一种免疫层析法(幽门螺杆菌粪便抗原检测试剂盒-侧向流层析)。所有研究中使用的粪便抗原检测方法均基于单克隆抗体。我们使用两种标准方法(组织学和快速尿素酶试验)评估了 168 例成年幽门螺杆菌感染患者。Premier Platinum HpSA Plus 的敏感性和特异性分别为 90%和 91%,Hp Ag 分别为 77%和 91%,幽门螺杆菌粪便抗原检测试剂盒分别为 81%和 92%。研究中使用的粪便抗原检测方法与标准方法之间的最佳一致性是与 Premier Platinum HpSA Plus。基于免疫层析法的粪便抗原检测(幽门螺杆菌粪便抗原检测)比基于 EIA 的检测(Hp Ag)更敏感。本研究的两个重要结论之一是,Premier Platinum HpSA Plus 是在根除治疗前诊断成年消化不良患者幽门螺杆菌感染最准确的方法,另一个结论是单克隆和高质量、可靠的免疫层析法检测是一个不错的选择,特别是对于那些没有适当设备进行 EIA 检测且样本量较少的小型医院实验室。