Wong Wai Man, Lam Shiu Kum, Xia Harry H X, Tang Vera Sy, Lai Kam Chuen, Hu Wayne H C, Chan Chi Kuen, Cheung Kwan Lok, Wong Benjamin C Y
Department of Medicine, University of Hong Kong, Queen Mary Hospital, Hong Kong.
J Gastroenterol Hepatol. 2002 Dec;17(12):1272-7. doi: 10.1046/j.1440-1746.2002.02879.x.
The performance of existing near patient tests for the diagnosis of Helicobacter pylori remains unsatisfactory. The aim of this study is to evaluate the accuracy of a new near patient test (Signify H. pylori) for the diagnosis of H. pylori and the usefulness of the Signify H. pylori test for a test and treat strategy.
Consecutive dyspeptic patients referred for upper endoscopy were recruited. Rapid urease test and histology were used as the gold standard. After endoscopy, blood was collected for the Signify H. pylori test and compared with a gold standard.
Two hundred and forty-four patients were eligible for analysis and 121 (49.5%) were positive for H. pylori. The Signify H. pylori test showed a sensitivity, specificity, and accuracy of 84.3, 89.4%, and 86.9%, respectively, for whole blood and 79.3, 88.6, and 84.0% for serum, respectively. The sensitivity and specificity of the Signify H. pylori whole blood test was 87.5 and 92.6% for patients less than 45-years-old and the accuracy was similar between patients referred from primary care physicians or gastroenterologists. The test is easy to operate and results are available within 5 min.
The Signify H. pylori test is accurate for the near patient diagnosis of H. pylori infection.
现有的用于诊断幽门螺杆菌的即时检验性能仍不尽人意。本研究旨在评估一种新型即时检验（Signify幽门螺杆菌检测）对幽门螺杆菌诊断的准确性以及该检测在检测和治疗策略中的实用性。
招募连续转诊进行上消化道内镜检查的消化不良患者。快速尿素酶试验和组织学检查用作金标准。内镜检查后，采集血液进行Signify幽门螺杆菌检测，并与金标准进行比较。
244例患者符合分析条件，121例（49.5%）幽门螺杆菌检测呈阳性。Signify幽门螺杆菌检测对全血的敏感性、特异性和准确性分别为84.3%、89.4%和86.9%，对血清的敏感性、特异性和准确性分别为79.3%、88.6%和84.0%。对于年龄小于45岁的患者，Signify幽门螺杆菌全血检测的敏感性和特异性分别为87.5%和92.6%，由初级保健医生或胃肠病学家转诊的患者之间的准确性相似。该检测操作简便，5分钟内即可获得结果。
Signify幽门螺杆菌检测对于即时诊断幽门螺杆菌感染是准确的。
