Anderson J C, Cheng E, Roeske M, Marchildon P, Peacock J, Shaw R D
Department of Medicine, State University of New York at Stony Brook, USA.
Am J Gastroenterol. 1997 Jul;92(7):1135-9.
FlexsureHP is a bi-directional immunochromatographic device for detection of IgG antibodies to Helicobacter pylori in human serum. This test, requiring only three steps and a 4-min incubation, can be used as an office-based diagnostic test. The goal of this study was to compare the sensitivity and specificity of the FlexsureHP, when performed by a clinician, with the established ELISA in the evaluation of clinical samples in an office setting.
The sensitivity and specificity of the FlexsureHP, compared with the biopsy, is 92.4% and 83.0%, respectively, with a positive predictive value of 88.4%. This was not significantly different from the results obtained when the ELISA was compared with biopsy data.
The immunochromatographic device, FlexsureHP, is a rapid, highly sensitive, and moderately specific office-based diagnostic test for H. pylori infection.
FlexsureHP是一种用于检测人血清中幽门螺杆菌IgG抗体的双向免疫层析装置。该检测只需三步且孵育4分钟，可作为门诊诊断检测。本研究的目的是比较临床医生操作FlexsureHP时的灵敏度和特异性与既定的酶联免疫吸附测定法（ELISA）在门诊环境中评估临床样本时的情况。
与活检相比，FlexsureHP的灵敏度和特异性分别为92.4%和83.0%，阳性预测值为88.4%。这与ELISA与活检数据比较时获得的结果无显著差异。
免疫层析装置FlexsureHP是一种用于幽门螺杆菌感染的快速、高灵敏度且具有中等特异性的门诊诊断检测方法。
