Test ID: SHELM
Helicobacter pylori Antibody, IgM, Serum
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
Screening for Helicobacter pylori infection
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
Gap
H pylori
H. Pylori IgM Antibody Serology
Helicobacter Pylori (Campylobacter Pylori)
Serol,Helicobac(S)
Ulcer Antibody Test
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.
Container/Tube:
Preferred: Red top
Acceptable: Serum gel
Specimen Volume: 0.6 mL
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 | Mild OK; Gross reject |
| Lipemia | Mild OK; Gross reject |
| Icterus | NA |
| Other | NA |
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 |
|---|---|---|
| Serum | Refrigerated (preferred) | 14 days |
| Frozen | 14 days |
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Helicobacter pylori is a spiral-shaped, gram-negative bacillus that has been associated with gastritis, gastric and duodenal ulcers, and gastric malignancies.
Helicobacter pylori is found worldwide. In Caucasian populations in the United States and other industrialized countries, Helicobacter pylori infection is infrequent in childhood. Prevalence increases 0.5% to 2% with each year of age, reaching about 50% in those who are 60 or older. Prevalence rates appear to be higher in blacks and Hispanics than in whites. In a random population of 200 apparently healthy blood donors tested for Helicobacter pylori IgG antibody, the positive rate was 27.5% with an equivocal rate of 5.5%.
The diagnosis of Helicobacter pylori gastrointestinal disease is supported by the presence of serum antibodies: IgG, IgM, or IgA, to the organism. Screening patients for the presence of antibodies to Helicobacter pylori is a convenient, noninvasive means for assessing whether gastrointestinal symptoms may be related to Helicobacter pylori infection.
Because serology may lack specificity, additional noninvasive tests can be used to confirm Helicobacter pylori infection including the urease breath test (#81590 Helicobacter pylori Breath Test) or stool antigen test for Helicobacter pylori (#81806 Helicobacter Pylori Antigen, Feces). The gold standard for diagnosis of Helicobacter pylori disease is a biopsy of infected tissue and evaluating the tissue by Gram, silver, Giemsa, or acridine orange stains; or by immunofluorescence or immunoperoxidase methods; rapid urease testing; and/or culture.
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 (Results with index values of <36.00 are negative.)
Equivocal (Results with index values of > or =36.00 but < or =40.00 are equivocal.)
Positive (Results with index values of >40.00 are positive.)
Interpretation Provides information to assist in interpretation of the test results
Patients with Helicobacter pylori infection nearly always develop antibodies of the IgG class and less frequently develop antibodies of the IgA class. IgM antibodies may be produced shortly after the onset of infection. Levels of IgM antibodies should decrease after successful treatment, but may again increase if recurrence or relapse of infection occurs.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
This assay should be performed only on patients with gastrointestinal symptoms because of the large percentage of Helicobacter pylori colonized individuals, especially in older age groups (estimated to be 40%-60% of asymptomatic Caucasians older than 60 years).
The serologic results must be interpreted in light of the clinical signs and symptoms of the patient.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Blaser MJ: Helicobacter pylori and related organisms. In Principles and Practice of Infectious Diseases. Vol. 2. 4th edition. Edited by GL Mandell, R Dolin, JE Bennett. Churchill Livingstone Inc., 1995, pp 156-164
2. Perez-Perez GI, Taylor DN, Bodhidatta L, et al: Seroprevalence of Helicobacter pylori infections in Thailand. J Infect Dis 1990;29:2139-2143
3. Drumm B, Perez-Perez GI, Blaser MJ, et al: Intrafamilial clustering of Helicobacter pylori infection. N Engl J Med 1990;322:359-363
4. Morris AJ, Ali MR, Nicholson GI, et al: Long term follow-up of voluntary ingestion of Helicobacter pylori. Ann Intern Med 1991;114:662-663
5. Evans DJ Jr, Evans DG, Graham DY, et al: A sensitive and specific serologic test for detection of Campylobacter pylori infection. Gastroenterology 1989;96:1004-1008
6. Glassman MS, Dallal S, Berezin SH, et al: Helicobacter pylori related gastroduodenal disease in children. Diagnostic utility of enzyme-linked immunosorbent assay (ELISA). Dig Dis Sci 1990;35:993-997
Method Description Describes how the test is performed and provides a method-specific reference
Partially purified Helicobacter pylori antigens are immobilized on the wells of a microwell plate. Diluted serum is added to the wells. IgM antibodies, specific to Helicobacter pylori, if present, bind to the antigen on the microwells. Excess antibodies are washed away with buffer. Antihuman IgM enzyme conjugate is added to the wells. The conjugate binds to the antigen-antibody complex on the plate. The excess enzyme conjugate is washed away and color is developed by the addition of an enzyme substrate. The intensity of the color corresponds directly to the amount of antibody present. (Package insert: GAP-IgM, BIOAMERICA, Inc., Newport Beach, CA, 2001)
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 Friday; 9 a.m.
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.
86677
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 |
|---|---|---|
| HELIM | Helicobacter pylori Ab, IgM, S | 5177-1 |
| DEXHM | Index Value | 5177-1 |
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