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Test Code STOOL PYL Helicobacter pylori Antigen, Feces

Additional Codes

Seattle Children's Test Name:  Stool Helicobacter pylori Antigen

 

This test is the suggested test to replace H. Pylori Antibody, IgG serology, which is no longer available.

Reporting Name

Helicobacter pylori Ag, F

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)


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.


Specimen Type

Fecal

Specimen Minimum Volume

5 g

Specimen Stability Information

Specimen Type Temperature Time
Fecal Frozen (preferred) 60 days
  Refrigerated  48 hours
Seattle Children's Hospital Note:

Note: Ambient samples will be rejected, must be refrigerated or frozen within 2 hours.

Preservatives are NOT acceptable.

Day(s) and Time(s) Performed

Monday through Saturday; Varies

Performing Laboratory

Mayo Medical Laboratories in Rochester

Method Name

Enzyme-Linked Immunosorbent Assay (ELISA)

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)

Reference Values

Negative

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

87338

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

Reject Due To

Hemolysis

NA

Lipemia

NA

Icterus

NA

Other

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

Testing Algorithm

See Helicobacter pylori Diagnostic Algorithm in Special Instructions.