Ozdemir Elif, Karabacak Neşe I, Degertekin Bülent, Cirak Meltem, Dursun Ayşe, Engin Doruk, Unal Selahattin, Unlü Mustafa
Department of Nuclear Medicine, Ankara Atatürk Training and Research Hospital, Ankara, Turkey.
Ann Nucl Med. 2008 Aug;22(7):611-6. doi: 10.1007/s12149-008-0168-6. Epub 2008 Aug 29.
The carbon-14 ((14)C) urea breath test (UBT) is a reliable and noninvasive technique for the diagnosis of Helicobacter pylori (HP) infection. The diagnostic performance of a new practical and low dose (14)C UBT system (Heliprobe, Stockholm, Sweden) was compared with those of other diagnostic tests, namely, rapid urease test (RUT), histopathology, and DNA detection using polymerase chain reaction (PCR).
Eighty-nine patients (mean age = 45 +/- 13, 30 men) with dyspeptic complaints who underwent an endoscopic procedure were studied. Biopsy specimens acquired during the procedure were subjected to RUT, histopathological examination using hematoxylin and eosin (HP-HE) and PCR. All patients underwent UBT using the Heliprobe system on a different day. The gold standard for HP positivity was defined as any two of the three tests being positive, excluding UBT, and the sensitivity and specificity of any single test alone were determined using this gold standard. Whenever only one test was positive, it was considered to be a false-positive one.
With the gold standard used in this study, 59 (66%) patients were diagnosed HP positive. The Heliprobe method detected HP infection with 96.6% sensitivity and 100% specificity and had the best diagnostic performance when compared with all the other methods. The sensitivity and specificity of the other methods for the detection of HP positivity were 89.8% and 100% for RUT, 93.2% and 63.3% for PCR, and 93.2% and 76.6% for HP-HE, respectively. Areas under the receiver-operating characteristic were 0.977 for UBT, 0.947 for RUT, 0.84 for HP-HE, and 0.775 for PCR.
Using a combination of invasive diagnostic tests as the gold standard, Heliprobe UBT was found to be highly sensitive and specific for the diagnosis of HP infection in patients with dyspeptic complaints.
碳-14（¹⁴C）尿素呼气试验（UBT）是诊断幽门螺杆菌（HP）感染的一种可靠且无创的技术。将一种新型实用低剂量¹⁴C UBT系统（Heliprobe，瑞典斯德哥尔摩）的诊断性能与其他诊断试验，即快速尿素酶试验（RUT）、组织病理学以及使用聚合酶链反应（PCR）的DNA检测进行比较。
对89例有消化不良症状且接受了内镜检查的患者（平均年龄 = 45 ± 13岁，30例男性）进行研究。在检查过程中获取的活检标本进行RUT、苏木精和伊红染色的组织病理学检查（HP-HE）以及PCR。所有患者在不同日期使用Heliprobe系统进行UBT。HP阳性的金标准定义为除UBT外三项试验中任意两项呈阳性，使用该金标准确定任何一项单独试验的敏感性和特异性。当只有一项试验呈阳性时，认为其为假阳性。
采用本研究中使用的金标准，59例（66%）患者被诊断为HP阳性。Heliprobe方法检测HP感染的敏感性为96.6%，特异性为100%，与所有其他方法相比具有最佳的诊断性能。其他检测HP阳性方法的敏感性和特异性分别为：RUT为89.8%和100%，PCR为93.2%和63.3%，HP-HE为93.2%和76.6%。受试者工作特征曲线下面积分别为：UBT为0.977，RUT为0.947，HP-HE为0.84，PCR为0.775。
以侵入性诊断试验组合作为金标准，发现Heliprobe UBT对有消化不良症状患者的HP感染诊断具有高度敏感性和特异性。
