1. Home
  2. Diagnostics
  3. H. pylori diagnostics
  4. H. pylori testing: All methods are not created equal
Contact Us

H. pylori testing: All methods are not created equal

H. pylori stool antigen testing for initial diagnosis and eradication confirmation testing

H. pylori infection is the greatest known risk factor for gastric cancer.1 Although
H. pylori infections are typically asymptomatic and do not require treatment, 20-25% of patients develop peptic ulcers or gastric cancer.

h_pylori-organism_transparent

Figure 1. In the United States, approximately 40% of individuals are seropositive for H. pylori antibodies.6

Test-Treat-Test strategy for H. pylori infection

H. pylori antibiotic resistance is on the rise, and rates of eradication are declining. A recent review of
H. pylori strain resistance patterns in the United States indicates resistance rates of 30-42% for clarithromycin, levofloxacin, and metronidazole.2 As a result, the American College of Gastroenterology (ACG), the American Gastroenterological Association (AGA), the Houston Consensus Conference, and the World Gastroenterology Organisation (WGO) recommend a “test-treat-test” strategy with stool antigen test or urea breath test (UBT) used to diagnose current H. pylori infection and to confirm eradication after treatment.

H. pylori stool antigen test or H. pylori UBT?

Both UBT and stool antigen tests offer excellent sensitivity and specificity for initial diagnosis of H. pylori infection and posttreatment testing3; however, there are significant differences between the two tests. H. pylori stool antigen tests require no patient preparation prior to sample collection, and samples can be transported and stored at room temperature for up to 96 hours, with results available in less than an hour.

UBT requires specialized equipment for analysis and may not be recommended for children or patients who are or may be pregnant or are breastfeeding due to the administration of radiolabeled urea. Unlike stool antigen testing, UBT requires the discontinuation of PPI and bismuth compounds before testing, for which patients are often uncompliant. H. pylori stool antigen tests offer a more cost-effective and workflow-friendly solution compared to H. pylori UBT.

Figure 2. Approximately 20% of H. pylori seropositive and symptomatic individuals are negative for stool antigen. The other 80% of seropositive and symptomatic individuals, stool antigen positive results indicate current H. pylori infection.6

What about H. pylori serology testing?

H. pylori antibodies are often detectable by serological evaluation for many years following infection resolution. Since antibody presence is not specific for a current H. pylori infection, serology testing is no longer used as a diagnostic tool in many laboratories. In addition, an increasing number of health insurance providers indicate that serologic testing is “not medically necessary” and no longer reimburse for H. pylori serology testing.4 In a review article published in the New England Journal of Medicine, serology testing was not included as an acceptable testing method for H. pylori infection diagnosis.5

The American Academy of Family Physicians (AAFP) and the American Society for Clinical Pathology (ASCP) do not consider serology testing for H. pylori to be clinically useful and do not support using serology for H. pylori testing. Currently, AAFP and ASCP recommend alternative noninvasive testing methods, such as the stool antigen test or UBT, to diagnose H. pylori infection and for eradication confirmation. These tests offer superior sensitivity and specificity when compared to serology, detecting the presence of H. pylori bacteria instead of antibodies to H. pylori.

Additional information

– H. pylori Stool Antigen Testing
– Whitepaper

Learn more about H. pylori

H. pylori diagnostics

Join our mailing list

Mailing list

References

  1. Wroblewski L.E., Peek R.M. Jr, Wilson K.T. Helicobacter pylori and gastric cancer: factors that modulate disease risk. Clin Microbiol Rev. 2010. 23(4):713-39. doi: https://doi.org/10.1128/CMR.00011-10.
  2. Ho, J.J.C., Navarro, M., Sawyer, K., Elfanagely, Y., Moss, S. F. Helicobacter pylori antibiotic resistance in the United States between 2011 and 2021: A systematic review and meta-analysis. Am J Gastroenterol. 2022. 117(8):1221–1230. doi: https://doi.org/10.14309/ajg.0000000000001828.
  3. El-Serag H.B., Kao J.Y., Kanwal F., et al. Houston Consensus Conference on Testing for Helicobacter pylori Infection in the United States. Clin Gastroenterol Hepatol. 2018. 16(7):992-1002.e6. doi: https://doi.org/10.1016/j.cgh.2018.03.013
  4. Theel E.S., Johnson R.D., Plumhoff E., Hanson C.A. Use of the Optum Labs Data Warehouse to assess test ordering patterns for diagnosis of Helicobacter pylori infection in the United States. J Clin Microbiol. 2015. 53(4):1358-60. doi: https://doi.org/10.1128/JCM.03464-14.
  5. Talley, N.J., Ford, A.C. Functional Dyspepsia. N Engl J Med 2015. 373(19):1853-1863. doi: https://doi.org/10.1056/nejmra1501505.
  6. Lee, J.Y. and Lyerly, D.M. Why stool antigen testing outperforms serology in identifying H. pylori. Clinical Laboratory Products. doi: https://tinyurl.com/488p689w