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Test Code HPSA Helicobacter pylori Antigen, Feces

Important Note

ASANTE order code: HPLYB

Epic/Beaker code is LAB5334

Performing Laboratory

Mayo Medical Laboratories in Rochester

Reporting Name

Helicobacter pylori Ag, F

Specimen Type


Specimen Required

Supplies: Stool Collection Kit, Random (T635)

Submission Container/Tube: Plastic container

Specimen Volume: 5 g

Collection Instructions: Mix stool well.

Additional Information: Falsely negative results may be obtained within 2 weeks of treatment with antimicrobials, bismuth, or proton pump inhibitors – see cautions for details.

Reject Due To








Very mucoid stool; or a watery, diarrheal specimen; stool in transport media, swab, or preservative

Specimen Stability Information

Specimen Type Temperature Time
Fecal Frozen (preferred) 60 days
  Refrigerated  48 hours

Specimen Minimum Volume

5 g

Day(s) and Time(s) Performed

Monday through Saturday; Varies

Specimen Retention Time

1 week

Analytic Time

Same day/1 day

Reference Values


Useful For

As an aid in the diagnosis of Helicobacter pylori


Monitoring the eradication of Helicobacter pylori after therapy (in most situations, confirmation of eradication is not mandatory)

Testing Algorithm

See Helicobacter pylori Diagnostic Algorithm in Special Instructions.

Method Name

Enzyme-Linked Immunosorbent Assay (ELISA)

Test Classification

This test has been cleared or approved by the U.S. Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information


LOINC Code Information

Test ID Test Order Name Order LOINC Value
HPSA Helicobacter pylori Ag, F 17780-8


Result ID Test Result Name Result LOINC Value
24088 Helicobacter pylori Ag, F 17780-8

Clinical Information

Helicobacter pylori is well recognized as the cause of chronic active gastritis, duodenal ulcer, and nonulcer dyspepsia.


Currently accepted methods for the diagnosis of Helicobacter pylori infection include, the urea breath test (UBT), and culture or histologic examination or direct urease testing (CLO test) of biopsy specimens obtained at the time of gastroduodenoscopy (ENDO). Each of these tests has its drawbacks, including lack of specificity (serology) or high cost, complexity, and inconvenience for the patient (UBT and ENDO).


The utility of this test in asymptomatic individuals is not known, but testing for Helicobacter pylori in such individuals is not generally recommended.


See Helicobacter pylori Diagnostic Algorithm in Special Instructions.


Positive results indicate the presence of Helicobacter pylori antigen in the stool.


Negative results indicate the absence of detectable antigen but does not eliminate the possibility of infection due to Helicobacter pylori.


Stool must be mixed thoroughly to ensure representative sampling.


This is a qualitative, not a quantitative, test.


Falsely negative results may be obtained within 2 weeks of treatment with antimicrobials, bismuth, or proton pump inhibitors. A negative test result in such a situation should be followed up with a repeat test at least 2 weeks after discontinuing therapy.


Interfering Substances: The following substances that may be present in human stool, DO NOT interfere with positive or negative test results at the stated concentrations per 500 microliters of human stool: TUMS (10 mg), Mylanta (0.84 mg), Pepto Bismol ( 0.35 mg), Tagamet (1 mg), Prilosec OTC (1 mg), barium sulfate (10 mg), whole blood (100 microliters), mucin (6.7 mg), human hemoglobin (ie, dark stool) (15 mg), steric + palmitic acids (ie, fatty stool) (7.9 mg).


Performance characteristics of the test have not been established for watery, diarrheal stools.

Clinical Reference

1. NIH Consensus Development Panel. Helicobacter pylori in peptic ulcer disease. JAMA 1994;272:65-69

2. Report of the Digestive Health Initiative. International Update Conference on H. pylori. Tysons Corner, McLean, VA, Feb 13-16, 1997

Method Description

The HpSA is a microwell-based enzyme-linked immunosorbent assay (ELISA) that detects Helicobacter pylori antigens present in human stool. It uses a plurality of monoclonal anti-Helicobacter pylori capture antibodies adsorbed to microwells. Diluted specimens from the patient and a peroxidase-conjugated polyclonal antibody are added to the wells and incubated for 1 hour at ambient temperature. A wash is performed and substrate is added; after 10 minutes of incubation, color develops in the presence of bound enzyme. The results can be read by observation or by use of a spectrophotometer.(Package insert: Premier Platinum HpSA PLUS, Meridian Diagnostics, Inc., Cincinnati, OH, February 2008)