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Assessment of Novel Enzyme Immunoassay for Helicobacter Phlori Stool Antigen

利用酵素免疫分析法偵測糞便中之幽門螺旋桿菌抗原之臨床評估

摘要


目前診斷幽門螺旋稈菌的方法不外乎是以內視鏡為主的侵襲性檢查及所謂的非侵襲性檢查,例如碳十三尿素呼氣測驗、血清幽門螺旋桿菌抗體等等。本文介紹一種新的非侵襲性檢測方法,其原理乃利用多株抗體攫取糞便中之幽門螺旋桿菌抗原。本研究之目的在瞭解此法之敏感度、特異性及凖確度。研究中共有九十一名患者因上腹不適而接受此一檢查並對照其內視鏡切片所得之快速尿素酶測驗及組織學結果得知其敏感度及特異性分別爲95.8%及91.9%,陽性及陰性預到值各為93.9%、94.4%,並有94.1%之凖確度,且臨床上具非侵襲性、簡單、快速、方便等優點,為一頗具潛力之診斷工具。

並列摘要


Enzyme immunoassay (EIA) for Helicobacter pylori (H.pylori) antigen in feces is a newly invented, noninvasive, simple rapid method to detect the presence of H.pylori in the stool. The presence of the antigen captured by the polyclonal antibody indicated an active infection state rather than an exposure only (antibody). In this study, we aimed to assess its diagnostic sensitivity, specificity and accuracy. Nine-one patients (52 males and 39 females, aged 16 to 74 with a mean of 45) with dyspetic symptoms were enrolled. All patients received panendoscpic examinations with biopsies for both CLO test and histological examinations.Stool samples from patients were tested for HpSA simultaneously. The sensitivity of the EIA test was 95.8%(46/48), and the specificity was 91.9% (34/37). The positive predictive and negative predictive values were 93.9%(46/49) and 94.4%(34/36), respectively,with a diagnostic accuracy of 94.1%. We concluded that ELA for HpSA is a rapid, simple, reliable and promising test.

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