Helicobacter pylori infection diagnostic test

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1] Associate Editor(s)-in-Chief: Yamuna Kondapally, M.B.B.S[2]


The nonendoscopic diagnostic testing methods for H. pylori include antibody tests, urea breath test, and fecal antigen test.

Nonendoscopic diagnostic studies

  • Antibody testing is inexpensive and widely available but poor PPV in populations with a low prevalence of H. pylori infection limits its usefulness in clinical practice.
  • The UBTs and fecal antigen tests provide reliable means of identifying active H. pylori infection before antibiotic therapy.
  • The UBT is the most reliable non endoscopic test to document eradication of H. pylori infection.
  • The monoclonal fecal antigen test provides another nonendoscopic means of establishing H. pylori cure after antibiotic treatment.
  • Testing to prove H. pylori eradication appears to be most accurate if performed at least 4 wk after the completion of antibiotic therapy.

The nonendoscopic diagnostic testing methods for H. pylori include:

  • Antibody tests
  • Urea breath test
  • Fecal antigen test

Antibody tests

Urea Breath Tests

  • The urea labeled with either the nonradioactive isotope 13C or the radioactive isotope 14C is ingested.
  • The H.pylori urease converts labeled urea to CO2, which can be quantitated in expired breath.
  • 13C labeled urea is preferred in children and pregnant females.
  • The urea breath test has 95% sensitivity and specificity.[6]
  • This test is an accurate means of post-treatment testing.[7][8]
  • As this test mainly depends on urease activity of H. pylori, the sensitivity of the test is decreased by medications such as bismuth containing products, PPIs, and antibiotics as they reduce organism density or urease activity. It is recommended to withhold PPIs for 7-14 days prior to the test, and bismuth and antibiotics are withheld for at least 28 days.[9][10][11]
  • Antacids do not affect the efficacy of the test.[12]

Fecal Antigen Test (FAT)

  • The fecal antigen test (FAT) is an enzyme immunoassay which identifies H. pylori antigen with the use of polyclonal anti-H.pylori antibody.[13][14]
  • Monoclonal antibodies can also be used to identify fecal H. pylori antigens.
  • Both tests are used to screen for infection and post-treatment testing.
  • The fecal antigen test is approved by U.S Food and Drug Administration as an alternative means of establishing H. pylori cure to urea breath test.
  • The polyclonal test has excellent sensitivity, specificity, and predictive values before treatment but less satisfactory after the treatment.
  • This test may be effective in confirming eradication of H. pylori infection as early as 14 days after treatment. However, it is suggested that it should be done more than 4 wk and up to 8-12 wk after H. pylori treatment.[15][13]
  • The sensitivity of the test is affected by the use of PPIs, bismuth compounds, and antibiotics. The specificity is affected by the bleeding peptic ulcer disease.[16]

Nonendoscopic testing Advantages Disadvantages
1. ELISA serology

(quantitative and qualitative)

  • Inexpensive and widely available
  • Very good NPV
  • Sensitivity (85-92%) and specificity (70-83%)
  • PPV dependent upon background H. pylori prevalence.
  • Not recommended after H. pylori therapy
  • Less accurate and does not identify infection
*2. Urea breath tests (13C and 14C)
  • Identifies active H. pylori infection.
  • Excellent PPV and NPV regardless of H. pylori prevalence.
  • Useful before and after H. pylori therapy
  • Sensitivity (95%) and specificity (96%)
  • Reimbursement and availability remain inconsistent
*3. Fecal antigen test
  • Identifies active H. pylori infection.
  • Excellent positive and negative predictive values regardless of H. pylori prevalence.
  • Useful before and after H. pylori therapy
  • Sensitivity (95%) and specificity (94%)
  • Polyclonal test less well validated than the UBT in the post treatment setting.
  • The monoclonal test appears reliable before and after antibiotic therapy.
  • Unpleasantness associated with collecting stool


  1. Ho B, Marshall BJ (2000). "Accurate diagnosis of Helicobacter pylori. Serologic testing". Gastroenterol Clin North Am. 29 (4): 853–62. PMID 11190069.
  2. Loy CT, Irwig LM, Katelaris PH, Talley NJ (1996). "Do commercial serological kits for Helicobacter pylori infection differ in accuracy? A meta-analysis". Am J Gastroenterol. 91 (6): 1138–44. PMID 8651160.
  3. Chey WD, Murthy U, Shaw S, Zawadski A, Montague J, Linscheer W; et al. (1999). "A comparison of three fingerstick, whole blood antibody tests for Helicobacter pylori infection: a United States, multicenter trial". Am J Gastroenterol. 94 (6): 1512–6. doi:10.1111/j.1572-0241.1999.1135_x.x. PMID 10364016.
  4. Gisbert JP, Pajares JM (2004). "Review article: 13C-urea breath test in the diagnosis of Helicobacter pylori infection -- a critical review". Aliment Pharmacol Ther. 20 (10): 1001–17. doi:10.1111/j.1365-2036.2004.02203.x. PMID 15569102.
  5. Chey WD (2000). "Accurate diagnosis of Helicobacter pylori. 14C-urea breath test". Gastroenterol Clin North Am. 29 (4): 895–902. PMID 11190074.
  6. Steen T, Berstad K, Meling T, Berstad A (1995). "Reproducibility of the 14C urea breath test repeated after 1 week". Am J Gastroenterol. 90 (12): 2103–5. PMID 8540496.
  7. Leodolter A, Domínguez-Muñoz JE, von Arnim U, Kahl S, Peitz U, Malfertheiner P (1999). "Validity of a modified 13C-urea breath test for pre- and posttreatment diagnosis of Helicobacter pylori infection in the routine clinical setting". Am J Gastroenterol. 94 (8): 2100–4. doi:10.1111/j.1572-0241.1999.01284.x. PMID 10445534.
  8. Perri F, Manes G, Neri M, Vaira D, Nardone G (2002). "Helicobacter pylori antigen stool test and 13C-urea breath test in patients after eradication treatments". Am J Gastroenterol. 97 (11): 2756–62. doi:10.1111/j.1572-0241.2002.07065.x. PMID 12425544.
  9. Graham DY, Opekun AR, Hammoud F, Yamaoka Y, Reddy R, Osato MS; et al. (2003). "Studies regarding the mechanism of false negative urea breath tests with proton pump inhibitors". Am J Gastroenterol. 98 (5): 1005–9. doi:10.1111/j.1572-0241.2003.07426.x. PMID 12809820.
  10. Chey WD, Woods M, Scheiman JM, Nostrant TT, DelValle J (1997). "Lansoprazole and ranitidine affect the accuracy of the 14C-urea breath test by a pH-dependent mechanism". Am J Gastroenterol. 92 (3): 446–50. PMID 9068466.
  11. Laine L, Estrada R, Trujillo M, Knigge K, Fennerty MB (1998). "Effect of proton-pump inhibitor therapy on diagnostic testing for Helicobacter pylori". Ann Intern Med. 129 (7): 547–50. PMID 9758575.
  12. Gatta L, Vakil N, Ricci C, Osborn JF, Tampieri A, Perna F; et al. (2004). "Effect of proton pump inhibitors and antacid therapy on 13C urea breath tests and stool test for Helicobacter pylori infection". Am J Gastroenterol. 99 (5): 823–9. doi:10.1111/j.1572-0241.2004.30162.x. PMID 15128344.
  13. 13.0 13.1 Gisbert JP, Pajares JM (2004). "Stool antigen test for the diagnosis of Helicobacter pylori infection: a systematic review". Helicobacter. 9 (4): 347–68. doi:10.1111/j.1083-4389.2004.00235.x. PMID 15270750.
  14. Gisbert JP, de la Morena F, Abraira V (2006). "Accuracy of monoclonal stool antigen test for the diagnosis of H. pylori infection: a systematic review and meta-analysis". Am J Gastroenterol. 101 (8): 1921–30. doi:10.1111/j.1572-0241.2006.00668.x. PMID 16780557.
  15. Vaira D, Vakil N, Menegatti M, van't Hoff B, Ricci C, Gatta L; et al. (2002). "The stool antigen test for detection of Helicobacter pylori after eradication therapy". Ann Intern Med. 136 (4): 280–7. PMID 11848725.
  16. Odaka T, Yamaguchi T, Koyama H, Saisho H, Nomura F (2002). "Evaluation of the Helicobacter pylori stool antigen test for monitoring eradication therapy". Am J Gastroenterol. 97 (3): 594–9. doi:10.1111/j.1572-0241.2002.05535.x. PMID 11922552.