Demıray Gürbüz Ebru, Gönen Can, Bekmen Neslihan, Dölek Devrim, Soytürk Müjde, Sağol Özgül, Şimşek İlkay, Yılmaz Özlem
Department of Medical Microbiology, Dokuz Eylül University, School of Medicine, İzmir, Turkey.
Turk J Gastroenterol. 2012;23(6):753-8.
BACKGROUND/AIMS: There is increasing interest in noninvasive tests for the assessment of Helicobacter pylori infection, and urine-based tests have been widely used as noninvasive tests to detect Helicobacter pylori infection. The aim of this study was to evaluate the adaptation and usefulness of urine antibody enzyme-linked immunosorbent assay and urine card tests in the clinical setting to detect anti-Helicobacter pylori IgG antibody excreted into urine in Turkish adult patients with dyspepsia.
One-hundred twenty-four patients who were admitted and referred for upper endoscopy to Dokuz Eylül University Hospital, Gastroenterology Clinic were studied. Antrum and corpus biopsies were taken, and Helicobacter pylori status was defined in the presence of at least two positive results of rapid urease test, histopathology and culture. Urine and serum specimens of 124 patients were collected and examined for anti-Helicobacter pylori IgG antibody by URINELISA, RAPIRUN (Otsuka Pharmaceutical, Tokyo, Japan) and anti-Helicobacter pylori enzyme-linked immunosorbent assay (Euroimmun, Lübeck, Germany) tests, respectively.
Helicobacter pylori infection was positive in 82 (66.1%) patients according to the gold standard methods. Among 82 Helicobacter pylori infection-positive patients, 69 patients were positive by both URINELISA and RAPIRUN; 109 of 124 patients were positive by anti-Helicobacter pylori IgG enzyme-linked immunosorbent assay. The sensitivity and specificity of URINELISA, RAPIRUN and anti-Helicobacter pylori IgG enzyme-linked immunosorbent assay were 74.4%, 73.2%, 100% and 81.0%, 78.6%, 35.7%, respectively. However, the urine antibody test cut-off values were searched for the best concordance with the results of gold standard methods. This yielded that the sensitivity and specificity of URINELISA with our new cut-off value (0.530) were 90.2% and 71.4%, respectively.
As a first study among Turkish adult patients with dyspepsia, the efficacy of URINELISA was related with the determination of a new cut-off value for pretreatment as a screening test value. We suggest that the cut-off value of the URINELISA test should be evaluated and considered for each patient group and each country. The URINELISA (OD 0.530) and RAPIRUN tests were found useful for the diagnosis of Helicobacter pylori infection in our patients with dyspepsia.
背景/目的：对用于评估幽门螺杆菌感染的非侵入性检测方法的关注日益增加，基于尿液的检测已被广泛用作检测幽门螺杆菌感染的非侵入性检测方法。本研究的目的是评估尿液抗体酶联免疫吸附测定和尿卡检测在临床环境中对土耳其成年消化不良患者尿液中排出的抗幽门螺杆菌IgG抗体的适用性和实用性。
研究了124名因上消化道内镜检查而入住多库兹艾吕尔大学医院胃肠病科的患者。采集胃窦和胃体活检组织，根据快速尿素酶试验、组织病理学和培养至少两项阳性结果确定幽门螺杆菌感染状态。分别收集124例患者的尿液和血清标本，通过尿酶联免疫吸附测定（URINELISA）、RAPIRUN（日本东京大冢制药公司）和抗幽门螺杆菌酶联免疫吸附测定（德国吕贝克欧蒙公司）检测抗幽门螺杆菌IgG抗体。
根据金标准方法，82例（66.1%）患者幽门螺杆菌感染呈阳性。在82例幽门螺杆菌感染阳性患者中，69例通过URINELISA和RAPIRUN检测均为阳性；124例患者中有109例通过抗幽门螺杆菌IgG酶联免疫吸附测定呈阳性。URINELISA、RAPIRUN和抗幽门螺杆菌IgG酶联免疫吸附测定的敏感性和特异性分别为74.4%、73.2%、100%和81.0%、78.6%、35.7%。然而，寻找尿液抗体检测的临界值以使其与金标准方法的结果具有最佳一致性。结果显示，采用我们新的临界值（0.530）时，URINELISA的敏感性和特异性分别为90.2%和71.4%。
作为对土耳其成年消化不良患者的首次研究，URINELISA的有效性与确定作为筛查检测值的预处理新临界值有关。我们建议应针对每个患者群体和每个国家评估和考虑URINELISA检测的临界值。发现URINELISA（OD 0.530）和RAPIRUN检测对我们的消化不良患者诊断幽门螺杆菌感染有用。
