Test ID: HPSA
Helicobacter pylori Antigen, Feces
Secondary ID 
A test code used for billing and in test definitions created prior to November 2011
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
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 situation(s) when tests are added to the initial order. This includes reflex and additional tests.
See Helicobacter pylori Diagnostic Algorithm in Special Instructions.
Special Instructions and Forms Describes specimen collection and preparation information, test algorithms, and other information pertinent to test. Also includes pertinent information and consent forms to be used when requesting a particular test
Method Name A short description of the method used to perform the test
Enzyme-Linked Immunosorbent Assay (ELISA)
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Aliases Lists additional common names for a test, as an aid in searching
H. Pylori Antigen, Stool
Helicobacter pylori (Campylobacter pylori)
pylori, Helicobacter (Campylobacter pylori)
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Collection Container/Tube: Stool container
Submission Container/Tube: Plastic container
Specimen Minimum Volume: 5 g
Collection Instructions: Mix stool well.
Forms: If not ordering electronically, submit a Microbiology Request Form (Supply T244) with the specimen.
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected
| Hemolysis | NA |
| Lipemia | NA |
| Icterus | NA |
| 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 laboratory. Alternate acceptable temperature(s) are also included.
| Specimen Type | Temperature | Time |
|---|---|---|
| Fecal | Frozen (preferred) | 60 days |
| Refrigerated | 48 hours |
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 Provides recommendations for further 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 HpSA is a microwell-based enzyme-linked immunosorbent assay (ELISA) that detects Helicobacter pylori antigens present in human stool. It uses polyclonal anti-Helicobacter pylori capture antibody 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)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Saturday; Varies
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
Test Classification Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
87338
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
| Result ID | Reporting Name | LOINC Code |
|---|---|---|
| 24088 | Helicobacter pylori Ag, F | 17780-8 |
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