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Test Code LAB1232579 Helicobacter pylori stool antigen

Performing Laboratory

Asante Rogue Regional Medical Center (ARRMC)

 

Performing Department

Special Chemistry

Specimen Required

Stool into a clean plastic container with no preservative

Sterile Empty Vial or Sterile Collection Cup

Specimen Minimum Volume

5 grams solid stool or 1 mL of liquid/semi-solid stool

Specimen Stability Information

Send to lab refrigerated at 2°-8° C

Stable 72 hours refrigerated at 2°-8° C

Reject Due To

  • Stool specimens collected in any type of preservative or specimens that are in Cary Blair transport media will be rejected.
  • Quantity not sufficient (QNS)
  • Lacking Two Patient Identifiers:
    • 1-Patient's First & Last name 
    • 2-Patient's Date of Birth

Day(s) Performed

Test Batched and performed Tuesday and Thursdays, results out by 4:30pm

Method Name

Chemiluminescent immunoassay technology, (CLIA)

CPT Code Information

87338

Clinical Information

H. pylori stool antigen assay is a chemiluminescent immunoassay (CLIA) intended for the qualitative determination of Helicobacter pylori antigen in human stool. The test is an aid in the diagnosis of patients suspected of H. pylori infection and to measure post therapy response from patients who have discontinued therapy for at least 4 weeks. Assay results should be used in conjunction with other clinical and laboratory data to assist the clinician in making individual patient management decisions.

 

Helicobacter pylori is a gram-negative, helix-shaped bacterium found in the human stomach. It is the causative agent of chronic gastritis or inflammation of the stomach lining, duodenal and stomach ulcers, and is associated with an increased risk of stomach cancer. Although the exact route of transmission is not known, oral-oral and/or fecal-oral routes are generally accepted. Once colonization of the stomach is established, H. pylori will likely persist indefinitely unless antimicrobial intervention is prescribed.

 

Unlike a majority of bacterial species, H. pylori is capable of colonizing the harsh acidic environment of the stomach. To accomplish this, H. pylori uses its flagella to actively burrow through the mucus reaching the stomach’s epithelial cell layer. Additionally, H. pylori produces urease, which degrades urea into carbon dioxide and ammonia, helping to neutralize the gastric acid present in the stomach.

Cautions

NOTE: Antimicrobials, proton pump inhibitors and bismuth preparations are known to suppress H. pylori and if ingested may give false negative results. In these cases, a new fecal sample should be collected and tested 14 days after treatment has stopped. Positive results from patients that have used antibiotics, PPIs, or bismuth compounds in the 14 days prior to fecal sample collection are still considered accurate.

 

Test results are reported as positive, negative, and equivocal.

  • For samples that are equivocal; a fresh specimen should be collected and tested

 

This H. pylori SA assay has not been evaluated in a pediatric population.

 

A negative test result does not preclude the possibility of the presence of H. pylori antigen in the specimen which may occur if the level of antigen is below the detection limit of the test.