H. Pylori Stool Antigen Test: Diagnostic Performance and Clinical Application
The stool antigen test is a highly accurate, non-invasive method for diagnosing active H. pylori infection with sensitivity and specificity of 93.2%, and should be used with validated laboratory-based monoclonal antibody tests rather than rapid in-office versions. 1
Diagnostic Accuracy
The stool antigen test demonstrates excellent performance characteristics that make it equivalent to the urea breath test (UBT):
- Pre-treatment diagnosis: Sensitivity 93.2% and specificity 93.2% based on evaluation of 3,419 patients 1
- Post-treatment confirmation: Sensitivity 92.1% and specificity 87.6% when using proper gold standards 1
- The European Helicobacter Pylori Study Group formally recommends using either UBT or stool antigen testing for initial diagnosis 1
Critical distinction: Only laboratory-based monoclonal antibody tests achieve this accuracy—rapid in-office immunochromatographic tests have significantly lower accuracy and should be avoided 1, 2
When to Use Stool Antigen Testing
Primary Indications
- Initial diagnosis in patients <50 years with uninvestigated dyspepsia and no alarm symptoms as part of "test and treat" strategy 3, 2
- Confirmation of eradication after treatment (wait at least 4 weeks post-therapy) 1, 3, 2
- Alternative to UBT when breath testing is unavailable or impractical 1
When NOT to Use (Proceed Directly to Endoscopy)
- Patients ≥50 years with new-onset dyspepsia (increased malignancy risk) 3, 2
- Any patient with alarm symptoms: bleeding, weight loss, dysphagia, palpable mass, or malabsorption 3, 2
- Patients who failed eradication therapy and need culture/susceptibility testing 2
Critical Pre-Test Requirements
Medication washout periods are essential to avoid false-negative results:
- Stop proton pump inhibitors (PPIs): At least 2 weeks before testing 1, 3, 2
- Stop antibiotics and bismuth: At least 4 weeks before testing 1, 3, 2
- PPIs can cause false-negative results in up to 40% of patients by reducing bacterial load 1
Common pitfall: Testing too soon after medication use is a frequent cause of false-negative results 1
Post-Treatment Confirmation
- Timing: Perform testing at least 4 weeks after completing eradication therapy 1, 3, 2
- Never use serology for post-treatment confirmation—antibodies persist long after eradication 2
- Monoclonal antibody-based stool tests show sensitivity of 91.6% and specificity of 98.4% for post-treatment assessment 4
Advantages Over Alternative Tests
- Detects active infection only (unlike serology which cannot distinguish current from past infection) 3, 2
- More practical than endoscopy: Avoids procedure-related discomfort, expense, and complications 3
- Safe in all populations: Can be used in children and pregnant women (unlike radioactive 14C-UBT) 1
- Cost-effective: Less expensive than UBT while maintaining comparable accuracy 5
Test Selection Algorithm
For initial diagnosis:
- Patient <50 years without alarm symptoms → Use validated monoclonal stool antigen test OR UBT 1, 3, 2
- Patient recently used PPIs/antibiotics → Either wait 2-4 weeks for washout, or consider validated IgG serology 1, 2
- Patient ≥50 years or with alarm symptoms → Endoscopy with biopsy-based testing 3, 2
For post-treatment confirmation:
- Wait minimum 4 weeks after completing therapy 1, 3, 2
- Ensure proper medication washout (PPIs 2 weeks, antibiotics 4 weeks) 1, 3, 2
- Use monoclonal stool antigen test OR UBT—never serology 1, 3, 2
Important Caveats
- Stool consistency matters: Accuracy decreases with unformed or watery stools due to antigen dilution 5
- Temperature and timing: Storage conditions and interval between collection and testing affect results 5
- Test kit selection: Choose validated monoclonal antibody-based laboratory tests, not rapid office tests 1, 2
- False negatives at end of therapy: All patients may test negative immediately after completing treatment, even if eradication failed—this is why 4-week delay is mandatory 6
Treatment Following Positive Test
When stool antigen test confirms H. pylori infection, standard eradication therapy includes: