Test Catalog

Test Id : HPSAF

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Helicobacter pylori Antigen, Feces

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

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)

 

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

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

See Helicobacter pylori Diagnostic Algorithm in Special Instructions.

Method Name
A short description of the method used to perform the test

Chromatographic Immunoassay

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

No

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Helicobacter pylori Ag, F

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

See Helicobacter pylori Diagnostic Algorithm in Special Instructions.

Specimen Type
Describes the specimen type validated for testing

Fecal

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Collection Container/Tube: Stool container

Submission Container/Tube: Plastic container

Specimen Minimum Volume: 5 g

Collection Instructions: Mix stool well.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

5 g

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

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

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Fecal Frozen (preferred) 60 days
Refrigerated 72 hours

Useful For
Suggests clinical disorders or settings where the test may be helpful

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)

 

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

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

See Helicobacter pylori Diagnostic Algorithm in Special Instructions.

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

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 serologic tests, 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).

 

See Helicobacter pylori Diagnostic Algorithm in Special Instructions.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Negative

Interpretation
Provides information to assist in interpretation of the test results

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.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

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
Recommendations for in-depth reading of a clinical nature

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
Describes how the test is performed and provides a method-specific reference

The ImmunoCard Helicobacter pylori stool antigen test consists of a chromatography strip housed in a plastic frame and enclosed in a foil pouch with a desiccant. The strip carries monoclonal anti-H. pylori capture antibody for the test and an animal protein for a control. The strips also contain red-latex conjugated anti-H. pylori and blue latex-conjugated anti-protein as the detector antibodies for tests and controls, respectively.(ImmunoCard STAT HpSA, Meridian Bioscience, Inc., Cincinnati, Ohio , 2003)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Saturday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

Same day/1 to 3 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

1 week

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Jacksonville

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

87338

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
HPSAF Helicobacter pylori Ag, F 80373-4
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
35920 Helicobacter pylori Ag, F 17780-8

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | PHP Pdf | CMS Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports