The Korean journal of internal medicine

The Korean Association of Internal Medicine (대한내과학회)
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New monoclonal antibody-based test for Helicobacter pylori urease in gastric tissue

  • Kim, Do Hyun (Department of Internal Medicine, Saint Carollo Hospital) ;
  • Kim, Ho Dong (Department of Internal Medicine, Saint Carollo Hospital) ;
  • Park, Hyeuk (Department of Internal Medicine, Saint Carollo Hospital) ;
  • Choi, Seung (Department of Internal Medicine, Saint Carollo Hospital) ;
  • Beom, Jae Won (Department of Internal Medicine, Saint Carollo Hospital) ;
  • Kim, Woo Jong (Department of Internal Medicine, Saint Carollo Hospital) ;
  • Park, Chang Kook (Department of Internal Medicine, Saint Carollo Hospital) ;
  • Lee, Young Jik (Department of Pathology, Saint Carollo Hospital) ;
  • Park, Ju Young (Department of Pathology, Saint Carollo Hospital) ;
  • Kim, Hyung Rag (Department of Pathology, Saint Carollo Hospital) ;
  • Park, Chul (Department of Clinical Pathology, Gwang Yang Health College) ;
  • Joo, Young Eun (Department of Internal Medicine, Chonnam National University Medical School) ;
  • Jung, Young Do (Department of Biochemistry, Chonnam National University Medical School)
  • Received : 2014.04.10
  • Accepted : 2014.09.26
  • Published : 2016.01.01
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Abstract

Background/Aims: To evaluate a new monoclonal antibody for Helicobacter pylori urease in gastric tissue. Methods: A total of 107 volunteers were enrolled. All subjects underwent a $^{13}C$-urea breath test and esophagogastroduodenoscopy. Gastric aspirates were analyzed for pH and ammonia. Six biopsy specimens in the gastric antrum and body were obtained for a rapid urease test and histology. The new monoclonal antibody-based H. pylori urease test (HPU) was performed to rapidly and qualitatively detect urease in two biopsy specimens. Results: H. pylori infection was diagnosed in 73 subjects. The sensitivity and specificity of the HPU was 89% and 74%, respectively. The subjects were divided into two groups: one with true-positive and true-negative HPU results (n = 90) and the other with false-positive and false-negative HPU results (n = 17). Across all subjects, ammonia levels were $900.5{\pm}646.7$ and $604.3{\pm}594.3{\mu}mol/L$ (p > 0.05), and pH was $3.37{\pm}1.64$ and $2.82{\pm}1.51$ (p > 0.05). Sensitivity was higher in the presence of atrophic gastritis or intestinal metaplasia. Conclusions: HPU detected H. pylori in approximately 10 min. Gastric aspirate ammonia and pH levels did not affect the test results. Sensitivity was good in the presence of atrophic gastritis or intestinal metaplasia.

Keywords

References

  1. Goodwin CS, Mendall MM, Northfield TC. Helicobacter pylori infection. Lancet 1997;349:265-269. https://doi.org/10.1016/S0140-6736(96)07023-7
  2. Sipponen P. Update on the pathologic approach to the diagnosis of gastritis, gastric atrophy, and Helicobacter pylori and its sequelae. J Clin Gastroenterol 2001;32:196-202. https://doi.org/10.1097/00004836-200103000-00003
  3. Leal YA, Flores LL, Fuentes-Panana EM, Cedillo-Rivera R, Torres J. 13C-urea breath test for the diagnosis of Helicobacter pylori infection in children: a systematic review and meta-analysis. Helicobacter 2011;16:327-337. https://doi.org/10.1111/j.1523-5378.2011.00863.x
  4. Puetz T, Vakil N, Phadnis S, Dunn B, Robinson J. The Pyloritek test and the CLO test: accuracy and incremental cost analysis. Am J Gastroenterol 1997;92:254-257.
  5. Dixon MF, Genta RM, Yardley JH, Correa P. Classification and grading of gastritis: the updated Sydney System. International Workshop on the Histopathology of Gastritis, Houston 1994. Am J Surg Pathol 1996;20:1161-1181.
  6. European Helicobacter pylori Study Group. Guidelines for clinical trials in Helicobacter pylori infection: Working Party of the European Helicobacter pylori Study Group. Gut 1997;41 Suppl 2:S1-S9. https://doi.org/10.1136/gut.41.1.1
  7. Prince MI, Osborne JS, Ingoe L, Jones DE, Cobden I, Barton JR. The CLO test in the UK: inappropriate reading and missed results. Eur J Gastroenterol Hepatol 1999;11:1251-1254. https://doi.org/10.1097/00042737-199911000-00011
  8. Tokunaga Y, Shirahase H, Yamamoto E, et al. Modified rapid urease test for Helicobacter pylori detection in relation to an immunohistochemical stain. J Gastroenterol Hepatol 2000;15:617-621. https://doi.org/10.1046/j.1440-1746.2000.02213.x
  9. Zaitoun AM. Histology compared with chemical testing for urease for rapid detection of Helicobacter pylori in gastric biopsy specimens. J Clin Pathol 1993;46:684-685. https://doi.org/10.1136/jcp.46.7.684
  10. Borromeo M, Lambert JR, Pinkard KJ. Evaluation of "CLO-test" to detect Campylobacter pyloridis in gastric mucosa. J Clin Pathol 1987;40:462-463. https://doi.org/10.1136/jcp.40.4.462
  11. Cox AJ. Stomach size and its relation to chronic peptic ulcer. AMA Arch Pathol 1952;54:407-422.
  12. Shin CM, Kim N, Lee HS, et al. Validation of diagnostic tests for Helicobacter pylori with regard to grade of atrophic gastritis and/or intestinal metaplasia. Helicobacter 2009;14:512-519. https://doi.org/10.1111/j.1523-5378.2009.00726.x
  13. Hack HM, Parsonnet J, Triadafilopoulos G. Testing negative for Helicobacter pylori after methylene blue spraying of gastric mucosa. Gastrointest Endosc 1994;40:397-398. https://doi.org/10.1016/S0016-5107(94)70100-8
  14. Laine L, Lewin D, Naritoku W, Estrada R, Cohen H. Prospective comparison of commercially available rapid urease tests for the diagnosis of Helicobacter pylori. Gastrointest Endosc 1996;44:523-526. https://doi.org/10.1016/S0016-5107(96)70002-0
  15. Gisbert JP, Pajares JM. Review article: 13C-urea breath test in the diagnosis of Helicobacter pylori infection: a critical review. Aliment Pharmacol Ther 2004;20:1001-1017. https://doi.org/10.1111/j.1365-2036.2004.02203.x
  16. Makristathis A, Barousch W, Pasching E, et al. Two enzyme immunoassays and PCR for detection of Helicobacter pylori in stool specimens from pediatric patients before and after eradication therapy. J Clin Microbiol 2000;38:3710-3714.
  17. Agha-Amiri K, Peitz U, Mainz D, Kahl S, Leodolter A, Malfertheiner P. A novel immunoassay based on monoclonal antibodies for the detection of Helicobacter pylori antigens in human stool. Z Gastroenterol 2001;39:555-560. https://doi.org/10.1055/s-2001-16629
  18. Shimoyama T, Kato C, Kodama M, Kobayashi I, Fukuda Y. Applicability of a monoclonal antibody-based stool antigen test to evaluate the results of Helicobacter pylori eradication therapy. Jpn J Infect Dis 2009;62:225-227.
  19. Monteiro L, Gras N, Vidal R, Cabrita J, Megraud F. Detection of Helicobacter pylori DNA in human feces by PCR: DNA stability and removal of inhibitors. J Microbiol Methods 2001;45:89-94. https://doi.org/10.1016/S0167-7012(01)00225-1
  20. Demirturk L, Yazgan Y, Tarcin O, et al. Does N-acetyl cystein affect the sensitivity and specificity of Helicobacter pylori stool antigen test? Helicobacter 2003;8:120-123. https://doi.org/10.1046/j.1523-5378.2003.00132.x