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Reliability of Diagnostic Tests for Helicobacter Pylori Infection Reliability of diagnostic tests for Helicobacter pylori infection Stefan Redéen, Fredrik Petersson, E. Törnkrantz, H. Levander, Erik Mårdh and Kurt Borch Linköping University Post Print N.B.: When citing this work, cite the original article. Original Publication: Stefan Redéen, Fredrik Petersson, E. Törnkrantz, H. Levander, Erik Mårdh and Kurt Borch, Reliability of diagnostic tests for Helicobacter pylori infection, 2011, Gastroenterology Research and Practice, (2011), 940650. http://dx.doi.org/10.1155/2011/940650 Licensee: Hindawi Publishing Corporation http://www.hindawi.com/ Postprint available at: Linköping University Electronic Press http://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-56574 Hindawi Publishing Corporation Gastroenterology Research and Practice Volume 2011, Article ID 940650, 6 pages doi:10.1155/2011/940650 Research Article Reliability of Diagnostic Tests for Helicobacter pylori Infection S. Redeen,´ 1, 2 F. Petersson,3 E. Tornkrantz,¨ 1, 2 H. Levander,1, 2 E. Mardh,˚ 1, 2 and K. Borch1, 2 1 Division of Surgery, Department of Clinical and Experimental Medicine, Faculty of Health Sciences, University Hospital, Linkoping¨ University, 581 85 Linkoping,¨ Sweden 2 Department of Surgery, County Council of Osterg¨ otland,¨ 581 85 Linkoping,¨ Sweden 3 Department of Pathology, National University Health System, Singapore 119074 Correspondence should be addressed to S. Redeen,´ [email protected] Received 1 March 2011; Accepted 26 May 2011 Academic Editor: Sergio Morini Copyright © 2011 S. Redeen´ et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Introduction. Helicobacter pylori (H. pylori) infection is very common worldwide. A reliable diagnosis is crucial for patients with H. pylori-related diseases. At followup, it is important to confirm that eradication therapy has been successful. There is no established gold standard for the diagnosis of H. pylori infection. Material and Methods. A sample of 304 volunteers from the general population was screened for H. pylori infection with serology, 13C-urea breath test (UBT), rapid urease test (RUT) on fresh biopsy, culture from biopsy, and histological examination. Culture was used as gold standard. Results. The sensitivity was 0.99 for serology, 0.90 for UBT, 0.90 for RUT, and 0.90 for histological examination. Corresponding specificities were 0.82, 0.99, 0.98, and 0.97, respectively. The accuracy was 0.86 for serology, 0.96 for UBT, 0.95 for RUT, 0.93 for culture, and 0.95 for histology. There was a strong correlation between the results of UBT and the histological scores of H. pylori colonisation as well as between the results of UBT and the scores of RUT. Conclusion. There were only minor differences in accuracy between the three invasive tests for H. pylori infection in this population. RUT may be recommended as the first choice since a result is obtained within hours. The accuracy of UBT was comparable to the invasive tests, and it is recommended for situations when endoscopy is not needed. 1. Introduction diagnosis is mandatory in ulcer disease [10–12]. This further underlines the necessity of a reliable diagnosis of H. pylori Helicobacter pylori (H. pylori) infection is very common infection both before and after eradication therapy [13–17]. worldwide [1–3]. The infection causes chronic gastritis Noninvasive clinical tests for detection of H. pylori in- which significantly increases the risk of developing gastric fection are serology (e.g., IgG or IgA antibodies against cell- or duodenal ulcer, gastric adenocarcinoma, and mucosa- surface antigens), 13C-urea breath test (UBT), and faecal associated lymphoid tissue (MALT) lymphoma [2, 4]. antigen tests [14, 15]. Serology mirrors past (within years) or Recommended indications for H. pylori eradication current infection. The reported sensitivity and specificity of therapy are: ulcer disease, MALT lymphoma, atrophic gas- serology measuring IgG antibodies is 80–100% and 69–95%, tritis, post gastric cancer partial resection, maintenance respectively [14–16]. Reported sensitivity and specificity for nonsteroidal anti-inflammatory drug treatment (NSAID) or aspirin ASA), and H. pylori infection in first degree relatives UBT is 81–100% and 80–98%, respectively [14–16, 18, ff to gastric cancer patients [5, 6]. Bleeding ulcer, sometimes 19]. Di erences between studies may in some instances be ff life threatening, is a common clinical consequence of explained by di erences in methodology and the choice of H. pylori infection [7, 8]. The incidence of bleeding ulcer gold standard. In patients with bleeding peptic ulcer the (gastric and duodenal) is almost unchanged since many performance of UBT seems to be superior to biopsy-based years, although there are reports indicating that the incidence methods and histological examination seems to be superior of duodenal ulcer is declining [8, 9]. Considering the fact that to RUT [20]. the fraction of NSAID- or ASA- (including low dose) related Invasive tests for diagnosis of H. pylori infection are or idiopathic ulcers has increased, a correct aetiological the rapid urease test (RUT), histological examination, and 2 Gastroenterology Research and Practice culture of gastric mucosal biopsies. Depending on the choice 60 min after ingestion of 50 mg 13Curea.Theresultusedis of gold standard, the sensitivity and specificity of RUT is from the 30-minute plot on the curve (delta over baseline 30) 80–95% and 90–100%, respectively, [14–16, 18]. Histological with an upper limit of 3.5 per mille. The participants were examination has a sensitivity of 83–95% and a specificity fasting and instructed to avoid proton pump inhibitors (PPI) of 90–100%, respectively [15, 16, 18]. For culture, the two weeks before the test. Those in need of PPI, for example, reported sensitivity and specificity is 80–90% and 95–100%, for gastroesophageal reflux disease, were prescribed low dose respectively [15, 16]. H2-blockers during the two weeks preceding UBT. Considering the biopsy-based tests, the outcome proba- After orientation, fixation in neutral formaldehyde, and bly is influenced by how many and where biopsies are taken routine processing of the gastric biopsies, sections cut (5-µm both in the elective and acute (bleeding) situations [13, 20– thick) perpendicular to the surface were stained with hema- 23]. toxylineosin, alcian blue-periodic acid-Schiff,andGiemsa There seems to be no firm agreement as to which stain. The histological degree of H. pylori colonisation in method should be used as gold standard for the detection of biopsy sections was scored as none, mild, moderate, or severe H. pylori infection. The aim of this study was to determine (0,1,2,3). the concordance between, and accuracy of, five different The microscopic examinations were performed by an tests for H. pylori infection in a population-based cohort experienced pathologist without knowledge of other data. examined with biopsies from both the antrum and corpus Kappa analysis of blinded repeat evaluation of the degree of of the stomach. Culture was used as gold standard. H. pylori colonisation in biopsy sections from the antrum and corpus in 50 participants (20 without gastritis or 2. Material and Methods H. pylori infection and 30 with chronic gastritis of whom 22 had H. pylori infection) yielded a Cohen’s Kappa statistic of 2.1. Study Population. The prevalence and natural history 0.897 and 0.824, respectively. ◦ of chronic gastritis and H. pylori infection in the studied Frozen biopsies kept at −80 C in glycerol contain- cohort have been published [24, 25]. The participants were ing freeze medium were defrosted in room temperature, initially randomly selected from the population register of homogenized, and spread onto H. pylori selective agar the mixed municipality of Linkoping,¨ Sweden. In association plates (developed at the Microbiology laboratory (LMC), with the follow-up study [25], the occurrence of H. pylori University Hospital of Linkoping,¨ Sweden). One culture infection was tested with five different methods (serology, medium was used. This is specific for H. pylori and contains UBT, RUT, culture, and histology) in 304 out of 314 GC agar (Acumedia, UK) developed at the accredited Micro- participants. None of the H. pylori infected participants had biology laboratory (LMC), University Hospital of Linkoping,¨ received eradication therapy. Ten participants had subclinical Sweden. The bacteria were cultured under microaerophilic ◦ prepyloric or duodenal ulcer at endoscopic screening [25]. conditions at 37 C and read after 5–7 days. Translucent colonies typical for H. pylori were recultured and read after 2.2. Endoscopy. The volunteers fasted for at least six hours another 5–7 days. After another seven days urease, catalase, before EGD. Blood samples were drawn and EGD car- and oxidase tests were done to confirm that the colonies were ried out after pharyngeal anaesthesia with lidocaine spray H. pylori, all three tests should be positive. (Xylocaine, AstraZeneca, Sodert¨ alje,¨ Sweden). Sedation with One fresh biopsy was taken from the corpus and antrum 2-3 mg intravenous flunitrazepam (Dormicum, Roche AB, and tested for occurrence of H. pylori with RUT (CLO-test, Stockholm, Sweden) was given on demand. Three biopsy Delta West Pty Ltd, Bentley, Australia), which was read after specimens were routinely collected from the gastric body 20 min and 1, 3, and 12 h (scored 4,3,2,1, resp.). Absence of (major, anterior and posterior aspect) and antrum (within H. pylori according to RUT was scored 0. 3 cm of the pylorus) for histological classification of chronic gastritis, including grading of H. pylori infection, according 2.4. Statistics. Agreement between the results of the H. pylori to the revised Sydney system [26]. One additional biopsy tests was evaluated by calculating the Cohen’s kappa coeffi- specimen from each of the corpus and antrum was collected cient. Dichotomized data were used to calculate sensitivity, for culture of H. pylori, and further one fresh biopsy from specificity, positive predictive value (PPV), negative predic- each location was analyzed for H.
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