Principles for choosing an H. pylori test in the primary care setting

1. Non-invasive testing should be limited to H. pylori tests that detect active infection only. Tests for active infection include:

• The HpSA® stool antigen test
• Urea breath test (UBT)

The American Gastroenterological Association no longer recommends serologic antibody testing either for primary diagnosis or to confirm eradication of H. pylori.

Serologic antibody tests do not distinguish between currently active infection with a past exposure or an infection that has been cured.

2. Testing should precede treatment. Antibiotics should not be prescribed without testing for H. pylori infection first.

3. Testing should only be performed in patients who will be administered treatment upon a positive result.

Criteria for the ideal Helicobacter pylori test in primary care

• Accurate diagnostic for active infection
• Sensitivity and specificity >90%
• Positive and negative predictive values >90%
• Immediate availability in-office or clinical laboratory
• Rapid turnaround
• Inexpensive
• Convenient for physician and patient
• Harmless
• Unaffected by immunological response

Learn more about the tests for H. pylori

Tests for H. pylori

HpSA stool antigen test

H. pylori antigen testing of human stool by enzyme immunoassay or immunochromatography (HpSA®) is one of the simplest and least expensive methods available. HpSA:

• Detects active infection with a sensitivity and specificity exceeding 90%;
• Has been approved for all ages;
• Is less affected by concomitant PPI use, and
• Is effective during the continuum of therapy.

Results of the stool antigen test aid in the definitive diagnosis of active H. pylori infection, can be used to monitor response during and after treatment, and can confirm eradication of H. pylori.

Confirmation of eradication should be performed 1 month after eradication therapy has been completed.

Download the HpSA package insert

Urea breath test (UBT)

The Urea Breath Test (UBT) measures radio-labeled carbon dioxide released through the breath when urease, the enzyme produced by H. pylori, breaks down a sample of C13- or C14-labeled urea. The UBT:

• Is indicated for patients 18 years of age or older and should be administered by trained office staff
• Requires that the patient ingest a standard sample of labeled C13 or C14 and, at a predetermined time, produce a breath sample
• Requires a mass spectrometer or scintillation counter
• Patients are required to be off the following medications. Proton Pump inhibitors, Bismuths, and antimicrobials two weeks prior to being tested.
• Patient procedure requires that the patient ingest a citric solution that contains Phenylalanine.

False positive tests could occur in patients who have achlorhydria.

Serologic antibody testing

The American Gastroenterological Association no longer recommends serologic antibody testing either for primary diagnosis, or to confirm eradication of H. pylori.² Serologic antibody tests do not distinguish between currently active infection with a past exposure, or an infection that has been cured.

"The accuracy of serologic tests has been questioned, and the stool antigen test and the urea breath test are therefore recommended for both the initial diagnosis and for confirmation of eradication. Use of serologic testing for the initial diagnosis of H. pylori requires its validation at a local level. This is difficult to accomplish in routine practice; therefore, for practical purposes, serologic testing for H. pylori is no longer recommended."²

Invasive testing

Invasive testing methods (i.e. histology, rapid urease testing, and culture) are based on endoscopy and biopsy. These techniques are reserved for patients who:

• Present with alarm signs
• Developed new symptoms after the age of 50 years
• Are 55 years of age or older