Coelho Luiz Gonzaga, Sant'Ana Carlos Roberto, Oliveira Ricardo Brandt de, Cezar Raíra César E, Araujo Aline Cordeiro Campos de, Silva Raisa Cristina Teodoro da, Trindade Osmar Reni, Coelho Maria Clara, Ferrioli Eduardo, Bendassolli José Albertino
Instituto Alfa de Gastroenterologia, Hospital das Clinicas, Universidade Federal de Minas Gerais, Belo Horizonte, MG, BR.
Centro de Energia Nuclear na Agricultura (CENA/USP), Universidade de Sao Paulo, Piracicaba, SP, BR.
Clinics (Sao Paulo). 2018 Jun 7;73:e16553. doi: 10.6061/clinics/2018/e16-553.
The 13C-urea breath test is the main non-invasive test for the diagnosis of Helicobacter pylori infection. The availability of this test throughout the country is limited, mainly due to the difficulty in obtaining the labeled isotope from abroad. Recently, researchers from the Nuclear Energy Center in Agriculture at the University of São Paulo (CENA/USP) succeeded in synthesizing 13C-enriched urea for Helicobacter pylori diagnosis. The aim of the study was to compare the performance of the 13C-urea breath test using 13C-urea acquired abroad with that of a test using 13C-urea synthesized in Brazil.
Sixty-four dyspeptic patients participated in the study (24 men and 40 women). Initially, the patients performed the 13C-urea breath test using the imported substrate (Euriso-Top, France). Seven to fourteen days later, all the patients repeated the test using the Brazilian substrate. The samples from both examinations were processed in an infrared isotope analyzer (IRIS, Wagner Analisen Technik, Germany), and all delta over baseline (DOB) [%] values above four were considered positive results.
Twenty-seven patients (42%) exhibited negative results for Helicobacter pylori infection, and thirty-seven patients (58%) exhibited positive results when tested using the foreign substrate (gold standard). There was a 100% concordance regarding the presence or absence of infection when the gold standard results were compared with those obtained using the Brazilian substrate.
Similar performance in the diagnosis of Helicobacter pylori infection was demonstrated when using the 13C-urea breath test with the Brazilian 13C-urea substrate and the test with the substrate produced abroad. This validation represents an important step toward increasing the availability of the 13C-urea breath test throughout the country, which will have a positive influence on the management of Helicobacter pylori infection.
13C尿素呼气试验是诊断幽门螺杆菌感染的主要非侵入性检测方法。该检测在全国的可及性有限，主要是因为从国外获取标记同位素存在困难。最近，圣保罗大学农业核能中心（CENA/USP）的研究人员成功合成了用于幽门螺杆菌诊断的富含13C的尿素。本研究的目的是比较使用从国外获取的13C尿素进行的13C尿素呼气试验与使用巴西合成的13C尿素进行的试验的性能。
64名消化不良患者参与了本研究（24名男性和40名女性）。最初，患者使用进口底物（法国Euriso-Top）进行13C尿素呼气试验。7至14天后，所有患者使用巴西底物重复该试验。两次检查的样本均在红外同位素分析仪（德国Wagner Analisen Technik公司的IRIS）中进行处理，所有高于基线的δ值（DOB）[％]大于4被视为阳性结果。
27名患者（42％）幽门螺杆菌感染检测结果为阴性，37名患者（58％）使用国外底物（金标准）检测时结果为阳性。将金标准结果与使用巴西底物获得的结果进行比较时，感染的有无一致性为100％。
使用巴西13C尿素底物进行13C尿素呼气试验与使用国外生产的底物进行的试验在幽门螺杆菌感染诊断中表现相似。这一验证是提高13C尿素呼气试验在全国可及性的重要一步，这将对幽门螺杆菌感染的管理产生积极影响。
