Dolak Werner, Bilgilier Ceren, Stadlmann Alexander, Leiner Judith, Püspök Andreas, Plieschnegger Wolfgang, Siebert Franz, Wewalka Friedrich, Schöfl Rainer, Huber-Schönauer Ursula, Datz Christian, Biowski-Frotz Susanne, Högenauer Christoph, Schrutka-Kölbl Christiane, Makristathis Athanasios, Schöniger-Hekele Maximilian, Steininger Christoph
Gastroenterology and Hepatology, Internal Medicine III., Medical University of Vienna, Vienna, Austria.
Department of Medicine I, Infectious Diseases, Internal Medicine I, Medical University of Vienna, Währinger Gürtel 18-20, 1090 Vienna, Austria.
Gut Pathog. 2017 Dec 22;9:78. doi: 10.1186/s13099-017-0226-5. eCollection 2017.
() causes a diversity of gastric diseases. Rapid urease tests (RUT) are well established for the point-of-care, invasive diagnosis of infection. The study aimed to evaluate the diagnostic performance of a new liquid RUT, the preOx-HUT, within a prospective cohort of treatment-naïve patients.
The multicenter prospective clinical trial was conducted at nine Austrian centers for gastrointestinal endoscopy. Patients referred for a diagnostic upper gastrointestinal endoscopy underwent gastric biopsy sampling for routine histological evaluation, and in parallel, the preOx-HUT. Histology served as reference standard to evaluate the diagnostic performance of the preOx-HUT.
From January 2015 to January 2016, a total of 183 consecutive patients (54 males and 129 females, median age 50 years) were included. Endoscopy revealed pathological findings in 149/183 cases (81%), which were mostly gastritis (59%) and gastro-esophageal reflux disease (27%). infection was detected by histology in 41/183 (22%) cases. In relation to histology, the preOx-HUT had a sensitivity of 85%, a specificity of 94%, a positive predictive value of 80% and a negative predictive value of 96%. Performance of preOx-HUT was not affected significantly by concomitant PPI-use as present in 15% of cases (P = 0.73).
This was the first study evaluating the preOx-HUT in a prospective, multicenter clinical setting. We found a high diagnostic accuracy for the point-of-care, invasive diagnostic test of infection. Hence, this test may be a valuable diagnostic adjunct to the clinical presentation of patients with suspected infection. EK 1548/2014, Name of registry: Register der Ethikkommission der Medizinischen Universität Wien, URL of registry: https://ekmeduniwien.at/core/catalog/2012/, Date of registration: 24.09.2014, Date of enrolment of the first participant to the trial: 15.01.2015.
（）可引发多种胃部疾病。快速尿素酶试验（RUT）是用于即时护理、侵入性诊断感染的成熟方法。本研究旨在评估一种新型液体RUT——preOx-HUT在未经治疗的患者前瞻性队列中的诊断性能。
这项多中心前瞻性临床试验在奥地利的九个胃肠内镜中心进行。因诊断性上消化道内镜检查而转诊的患者接受胃活检取样以进行常规组织学评估，同时进行preOx-HUT检测。组织学检查作为评估preOx-HUT诊断性能的参考标准。
2015年1月至2016年1月，共纳入183例连续患者（54例男性和129例女性，中位年龄50岁）。内镜检查在149/183例（81%）病例中发现病理结果，主要为胃炎（59%）和胃食管反流病（27%）。组织学检查在41/183例（22%）病例中检测到感染。与组织学检查相比，preOx-HUT的敏感性为85%，特异性为94%，阳性预测值为80%，阴性预测值为96%。15%的病例中同时使用质子泵抑制剂（PPI）对preOx-HUT的性能没有显著影响（P = 0.7³）。
这是第一项在前瞻性、多中心临床环境中评估preOx-HUT的研究。我们发现该即时护理、侵入性感染诊断测试具有较高的诊断准确性。因此，对于疑似感染患者的临床表现，该测试可能是一种有价值的诊断辅助手段。EK 1548/2014，注册机构名称：维也纳医科大学伦理委员会注册处，注册机构网址：https://ekmeduniwien.at/core/catalog/2012/，注册日期：2014年9月24日，试验第一名参与者入组日期：2015年1月15日。
