Evaluation of a novel continuous real time 13C urea breath analyser for Helicobacter pylori

Evaluation of a novel continuous real time 13C urea breath analyser for Helicobacter pylori
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DOI:
10.1046/j.1365-2036.2001.00926.x
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发表时间:
2001-03-01
影响因子:
7.6
通讯作者:
Avni, Y
Avni, Y
中科院分区:
医学1区
文献类型:
--
作者:
Shirin, H;Kenet, G;Avni, Y

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目的:为了评估一种新的C-13尿素呼气试验,Oridion BreathID,诊断Helicobacterpylori.Methods的敏感性和特异性:共97个连续的症状性患者被称为上消化道内窥镜检查包括在“治疗前”的研究的一部分。内镜检查后,分析患者的H。Pylori的Oridion BreathID。BreathID连续采集受试者的呼吸20 min,并在BreathID屏幕上真实的显示结果。将BreathID的结果与“金标准”(快速尿素酶试验和组织学)进行比较。我们还前瞻性地测试了BreathID与同位素比质谱法相比的有效性,在40名患者中进行了监测H。结果:在96.9%(94/97)的患者中观察到“金标准”和呼吸ID测试之间的完全一致性。BreathID的敏感性和特异性分别为97.8%和96.1%。结论:Oridion BreathID的灵敏度和特异性与目前使用的尿素呼气试验相当。此外,BreathID具有易于使用的潜在优势,对医务人员的要求最低,以及真实的快速结果(最长20分钟),这可能使BreathID优于其他尿素呼气测试测定。
Aim: To evaluate the sensitivity and specificity of a new C-13 urea breath test, Oridion BreathID, for the diagnosis of Helicobacter pylori.Methods: A total of 97 consecutive symptomatic patients referred for upper endoscopy were included in the 'pre-therapy' part of the study. After endoscopy the patients were analysed for H. pylori by Oridion BreathID. BreathID continuously sampled the subject's breath for 20 min, and displayed the results on the BreathID screen in real time. Results of the BreathID were compared with the 'gold standard' (rapid urease test and histology). We also prospectively tested the validity of BreathID in comparison to isotope ratio mass spectrometry, in 40 patients referred to monitor the efficacy of H. pylori eradication treatment.Results: Complete agreement was observed between the 'gold standard' and the Breath ID test in 96.9% (94 out of 97) of the patients. The sensitivity and specificity of BreathID were 97.8% and 96.1%, respectively. The correlation between BreathID and isotope ratio mass spectrometry breath test was 100%.Conclusions: The Oridion BreathID has comparable sensitivity and specificity to the claims of the currently available urea breath tests. Furthermore, BreathID has the potential advantages of ease of use with minimal medical staff requirement, and real time rapid results (20 min maximum) which may make the BreathID preferable to other urea breath test assays.