Indications and diagnostic tests for Helicobacter pylori infection
- Sheila E Crowe, MD, FRCPC, FACP, FACG, AGAF
Sheila E Crowe, MD, FRCPC, FACP, FACG, AGAF
- Professor of Medicine
- University of California, San Diego
Helicobacter pylori is the most prevalent chronic bacterial infection and is associated with peptic ulcer disease, chronic gastritis, gastric adenocarcinoma, and gastric mucosa associated lymphoid tissue (MALT) lymphoma [1-4].
This topic will review the clinical indications for testing for H. pylori, diagnostic tests for H. pylori, and their interpretation. Our recommendations are largely consistent with 2017 guidelines from the American College of Gastroenterology and the Maastricht V consensus report [5,6]. The epidemiology, pathophysiology, and immune response to H. pylori and treatment regimens for H. pylori infection are discussed separately. (See "Pathophysiology of and immune response to Helicobacter pylori infection" and "Acute and chronic gastritis due to Helicobacter pylori" and "Association between Helicobacter pylori infection and gastrointestinal malignancy" and "Association between Helicobacter pylori infection and duodenal ulcer" and "Bacteriology and epidemiology of Helicobacter pylori infection" and "Treatment regimens for Helicobacter pylori".)
INDICATIONS FOR TESTING
Testing for H. pylori should be performed only if the clinician plans to offer treatment for positive results. Indications for testing include:
●Low grade gastric mucosa associated lymphoid tissue (MALT) lymphoma.
●Active peptic ulcer disease or past history of peptic ulcer if cure of H. pylori infection has not been documented.
- NIH Consensus Conference. Helicobacter pylori in peptic ulcer disease. NIH Consensus Development Panel on Helicobacter pylori in Peptic Ulcer Disease. JAMA 1994; 272:65.
- Malfertheiner P, Megraud F, O'Morain CA, et al. Management of Helicobacter pylori infection--the Maastricht IV/ Florence Consensus Report. Gut 2012; 61:646.
- Chey WD, Wong BC, Practice Parameters Committee of the American College of Gastroenterology. American College of Gastroenterology guideline on the management of Helicobacter pylori infection. Am J Gastroenterol 2007; 102:1808.
- Laine L. Helicobacter pylori, gastric ulcer, and agents noxious to the gastric mucosa. Gastroenterol Clin North Am 1993; 22:117.
- Chey WD, Leontiadis GI, Howden CW, Moss SF. ACG Clinical Guideline: Treatment of Helicobacter pylori Infection. Am J Gastroenterol 2017; 112:212.
- Malfertheiner P, Megraud F, O'Morain CA, et al. Management of Helicobacter pylori infection-the Maastricht V/Florence Consensus Report. Gut 2017; 66:6.
- DuBois S, Kearney DJ. Iron-deficiency anemia and Helicobacter pylori infection: a review of the evidence. Am J Gastroenterol 2005; 100:453.
- Rostami N, Keshtkar-Jahromi M, Rahnavardi M, et al. Effect of eradication of Helicobacter pylori on platelet recovery in patients with chronic idiopathic thrombocytopenic purpura: a controlled trial. Am J Hematol 2008; 83:376.
- Parsonnet J, Harris RA, Hack HM, Owens DK. Modelling cost-effectiveness of Helicobacter pylori screening to prevent gastric cancer: a mandate for clinical trials. Lancet 1996; 348:150.
- Levi F, Lucchini F, Negri E, et al. Trends in cancer mortality in the European Union and accession countries, 1980-2000. Ann Oncol 2004; 15:1425.
- Talley NJ, Vakil NB, Moayyedi P. American gastroenterological association technical review on the evaluation of dyspepsia. Gastroenterology 2005; 129:1756.
- Gisbert JP, Abraira V. Accuracy of Helicobacter pylori diagnostic tests in patients with bleeding peptic ulcer: a systematic review and meta-analysis. Am J Gastroenterol 2006; 101:848.
- Gisbert JP, Esteban C, Jimenez I, Moreno-Otero R. 13C-urea breath test during hospitalization for the diagnosis of Helicobacter pylori infection in peptic ulcer bleeding. Helicobacter 2007; 12:231.
- Laine L, Lewin D, Naritoku W, et al. Prospective comparison of commercially available rapid urease tests for the diagnosis of Helicobacter pylori. Gastrointest Endosc 1996; 44:523.
- Yousfi MM, el-Zimaity HM, Genta RM, Graham DY. Evaluation of a new reagent strip rapid urease test for detection of Helicobacter pylori infection. Gastrointest Endosc 1996; 44:519.
- Young EL, Sharma TK, Cutler AF. Prospective evaluation of a new urea-membrane test for the detection of Helicobacter pylori in gastric antral tissue. Gastrointest Endosc 1996; 44:527.
- Nishikawa K, Sugiyama T, Kato M, et al. A prospective evaluation of new rapid urease tests before and after eradication treatment of Helicobacter pylori, in comparison with histology, culture and 13C-urea breath test. Gastrointest Endosc 2000; 51:164.
- Gatta L, Vakil N, Ricci C, et al. Effect of proton pump inhibitors and antacid therapy on 13C urea breath tests and stool test for Helicobacter pylori infection. Am J Gastroenterol 2004; 99:823.
- Weston AP, Campbell DR, Hassanein RS, et al. Prospective, multivariate evaluation of CLOtest performance. Am J Gastroenterol 1997; 92:1310.
- Siddique I, Al-Mekhaizeem K, Alateeqi N, et al. Diagnosis of Helicobacter pylori: improving the sensitivity of CLOtest by increasing the number of gastric antral biopsies. J Clin Gastroenterol 2008; 42:356.
- Wright CL, Kelly JK. The use of routine special stains for upper gastrointestinal biopsies. Am J Surg Pathol 2006; 30:357.
- Genta RM, Graham DY. Comparison of biopsy sites for the histopathologic diagnosis of Helicobacter pylori: a topographic study of H. pylori density and distribution. Gastrointest Endosc 1994; 40:342.
- Faigel DO, Childs M, Furth EE, et al. New noninvasive tests for Helicobacter pylori gastritis. Comparison with tissue-based gold standard. Dig Dis Sci 1996; 41:740.
- Mégraud F, Lehours P. Helicobacter pylori detection and antimicrobial susceptibility testing. Clin Microbiol Rev 2007; 20:280.
- Mégraud F. Rationale for the choice of antibiotics for the eradication of Helicobacter pylori. Eur J Gastroenterol Hepatol 1995; 7 Suppl 1:S49.
- Osato MS, Reddy R, Reddy SG, et al. Pattern of primary resistance of Helicobacter pylori to metronidazole or clarithromycin in the United States. Arch Intern Med 2001; 161:1217.
- Leide-Svegborn S, Stenström K, Olofsson M, et al. Biokinetics and radiation doses for carbon-14 urea in adults and children undergoing the Helicobacter pylori breath test. Eur J Nucl Med 1999; 26:573.
- Howden CW, Hunt RH. Guidelines for the management of Helicobacter pylori infection. Ad Hoc Committee on Practice Parameters of the American College of Gastroenterology. Am J Gastroenterol 1998; 93:2330.
- Laine L, Estrada R, Trujillo M, et al. Effect of proton-pump inhibitor therapy on diagnostic testing for Helicobacter pylori. Ann Intern Med 1998; 129:547.
- Bravo LE, Realpe JL, Campo C, et al. Effects of acid suppression and bismuth medications on the performance of diagnostic tests for Helicobacter pylori infection. Am J Gastroenterol 1999; 94:2380.
- Savarino V, Tracci D, Dulbecco P, et al. Negative effect of ranitidine on the results of urea breath test for the diagnosis of Helicobacter pylori. Am J Gastroenterol 2001; 96:348.
- Savarino V, Bisso G, Pivari M, et al. Effect of gastric acid suppression on 13C-urea breath test: comparison of ranitidine with omeprazole. Aliment Pharmacol Ther 2000; 14:291.
- Graham DY, Opekun AR, Jogi M, et al. False negative urea breath tests with H2-receptor antagonists: interactions between Helicobacter pylori density and pH. Helicobacter 2004; 9:17.
- Vakil N, Rhew D, Soll A, Ofman JJ. The cost-effectiveness of diagnostic testing strategies for Helicobacter pylori. Am J Gastroenterol 2000; 95:1691.
- Kelly SM, Pitcher MC, Farmery SM, Gibson GR. Isolation of Helicobacter pylori from feces of patients with dyspepsia in the United Kingdom. Gastroenterology 1994; 107:1671.
- Braden B, Teuber G, Dietrich CF, et al. Comparison of new faecal antigen test with (13)C-urea breath test for detecting Helicobacter pylori infection and monitoring eradication treatment: prospective clinical evaluation. BMJ 2000; 320:148.
- Trevisani L, Sartori S, Galvani F, et al. Evaluation of a new enzyme immunoassay for detecting Helicobacter pylori in feces: a prospective pilot study. Am J Gastroenterol 1999; 94:1830.
- Vaira D, Malfertheiner P, Mégraud F, et al. Diagnosis of Helicobacter pylori infection with a new non-invasive antigen-based assay. HpSA European study group. Lancet 1999; 354:30.
- Wu DC, Wu IC, Wang SW, et al. Comparison of stool enzyme immunoassay and immunochromatographic method for detecting Helicobacter pylori antigens before and after eradication. Diagn Microbiol Infect Dis 2006; 56:373.
- Veijola L, Myllyluoma E, Korpela R, Rautelin H. Stool antigen tests in the diagnosis of Helicobacter pylori infection before and after eradication therapy. World J Gastroenterol 2005; 11:7340.
- Makristathis A, Pasching E, Schütze K, et al. Detection of Helicobacter pylori in stool specimens by PCR and antigen enzyme immunoassay. J Clin Microbiol 1998; 36:2772.
- van Leerdam ME, van der Ende A, ten Kate FJ, et al. Lack of accuracy of the noninvasive Helicobacter pylori stool antigen test in patients with gastroduodenal ulcer bleeding. Am J Gastroenterol 2003; 98:798.
- Perri F, Manes G, Neri M, et al. Helicobacter pylori antigen stool test and 13C-urea breath test in patients after eradication treatments. Am J Gastroenterol 2002; 97:2756.
- Calvet X, Sánchez-Delgado J, Montserrat A, et al. Accuracy of diagnostic tests for Helicobacter pylori: a reappraisal. Clin Infect Dis 2009; 48:1385.
- Shimoyama T, Kobayashi I, Kato C, et al. Comparison of monoclonal antibody-based stool antigen tests to determine the results of Helicobacter pylori eradication therapy. Scand J Gastroenterol 2010; 45:1431.
- Gisbert JP, de la Morena F, Abraira V. Accuracy of monoclonal stool antigen test for the diagnosis of H. pylori infection: a systematic review and meta-analysis. Am J Gastroenterol 2006; 101:1921.
- Manes G, Balzano A, Iaquinto G, et al. Accuracy of stool antigen test in posteradication assessment of Helicobacter pylori infection. Dig Dis Sci 2001; 46:2440.
- Vaira D, Vakil N, Menegatti M, et al. The stool antigen test for detection of Helicobacter pylori after eradication therapy. Ann Intern Med 2002; 136:280.
- Lin HJ, Lo WC, Perng CL, et al. Helicobacter pylori stool antigen test in patients with bleeding peptic ulcers. Helicobacter 2004; 9:663.
- Gisbert JP, Trapero M, Calvet X, et al. Evaluation of three different tests for the detection of stool antigens to diagnose Helicobacter pylori infection in patients with upper gastrointestinal bleeding. Aliment Pharmacol Ther 2004; 19:923.
- Korkmaz H, Findik D, Ugurluoglu C, Terzi Y. Reliability of stool antigen tests: investigation of the diagnostic value of a new immunochromatographic Helicobacter pylori approach in dyspeptic patients. Asian Pac J Cancer Prev 2015; 16:657.
- Loy CT, Irwig LM, Katelaris PH, Talley NJ. Do commercial serological kits for Helicobacter pylori infection differ in accuracy? A meta-analysis. Am J Gastroenterol 1996; 91:1138.
- Liston R, Pitt MA, Banerjee AK. IgG ELISA antibodies and detection of Helicobacter pylori in elderly patients. Lancet 1996; 347:269.
- Nardone G, Coscione P, D'Armiento FP, et al. Cirrhosis negatively affects the efficiency of serologic diagnosis of Helicobacter pylori infection. Ital J Gastroenterol 1996; 28:332.
- Cutler AF, Toskes P. Comparison of [13C]urea blood test to [13C]urea breath test for the diagnosis of Helicobacter pylori. Am J Gastroenterol 1999; 94:959.
- Ahmed F, Murthy UK, Chey WD, et al. Evaluation of the Ez-HBT Helicobacter blood test to establish Helicobacter pylori eradication. Aliment Pharmacol Ther 2005; 22:875.
- Cutler AF, Prasad VM, Santogade P. Four-year trends in Helicobacter pylori IgG serology following successful eradication. Am J Med 1998; 105:18.
- INDICATIONS FOR TESTING
- APPROACH TO DIAGNOSTIC TESTING
- Medications that should be discontinued prior to testing
- Patient undergoing upper endoscopy
- Patients not undergoing upper endoscopy
- DIAGNOSTIC TESTS
- Endoscopic testing
- - Biopsy urease testing
- - Histology
- - Bacterial culture and sensitivity testing
- Noninvasive testing
- - Urea breath testing
- - Stool antigen assay
- - Serology
- - Other infrequently used tests
- CONFIRMATION OF ERADICATION
- SOCIETY GUIDELINE LINKS
- INFORMATION FOR PATIENTS
- SUMMARY AND RECOMMENDATIONS