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24997 Helicobacter pylori Antibody, IgM (HPYM)

Helicobacter pylori Antibody, IgM (HPYM)
Test Code: HEPYMSO
Synonyms/Keywords
​Lab Ref Code:  84408, Campylobacter, Gap, H pylori, H. Pylori IgM Antibody Serology, Helicobacter Pylori (Campylobacter Pylori), Serol Helicobac(S), Ulcer Antibody Test
Useful For

Screening for Helicobacter pylori infection

This test will be obsoleted effective March 1st in effort to conform to current H pylori testing guidelines and to improve patient management. Both the American Gastroenterological Associationg and the American College of Gastroenterology recommend that serologic testing for H pylori be avoided as a means diagnosis of active H pylori infection due to the following limitations:

-poor positive predictive value (PPV)
-poor performance characteristics of these assays compared to alternative tests (MISC Mayo Codes UBT & HPSA)
-serologic testing cannot be used to distinguish active from past infection or to document eradication of the organism following successful treatment
-lack of reimbursement from an increasing number of insurance providers

To minimize improper diagnosis and unnecessary treatment regimens, providers are strongly encouranged to amend their testing strategies by replacing serologic evaluation of patients with suspected H pylori infection, with either the urea breath test (UBT) or stool antigen Test (HPSA).

Specimen Requirements
Specimen Type Preferred Container/Tube Acceptable Container/Tube Specimen Volume Specimen Minimum Volume
(allows for 1 repeat)		 Pediatric Minimum Volume
(no repeat)
Serum​ ​Red Top Tube (RTT) ​Serum Separator Tube (SST) ​0.6 mL ​0.4 mL ​
Specimen Stability Information
Specimen Type Temperature Time
Serum​ Refrigerated (preferred)​ ​1days
​ ​Frozen ​14 days
Rejection Criteria
Hemolysis
Mild OK; Gross reject
​Lipemia
Mild OK; Gross reject
Performing Laboratory Information
Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation
Mayo Medical Laboratories​​
 Monday through Friday; 9 a.m.
​
Same day/1 day
​
Enzyme-Linked Immunosorbent Assay (ELISA) 
Reference Lab
Mayo Clinic Laboratories
Test Information

This test should be regarded as 'Research Use Only'. This test has not been cleared or approved by the U.S. Food and Drug Administration. It may not be covered by insurance and providers need to inform all patients of this prior to ordering. 

For Medicare patients, an Advanced Beneficiary notice (ABN) is required; for Medicaid patients, a Noncovered Services Waiver is required, and for commercial payers, prior authorization should be obtained.   ​

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 convinient, noninvasive means for assessing whether gastrointestinal symptoms may be related to Helicobacter pylori infection​.

Reference Range Information
Performing Location Reference Range
Mayo Medical Laboratories​​
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

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.

Outreach CPTs
CPT Modifier
(if needed)		 Quantity Description Comments
​86677 ​ ​ ​ ​
Classification

This test should be regarded as 'Research Use Only'. This test has not been cleared or approved by the U.S. Food and Drug Administration. It may not be covered by insurance and providers need to inform all patients of this prior to ordering. 

For Medicare patients, an Advanced Beneficiary notice (ABN) is required; for Medicaid patients, a Noncovered Services Waiver is required, and for commercial payers, prior authorization should be obtained.  

Synonyms/Keywords
​Lab Ref Code:  84408, Campylobacter, Gap, H pylori, H. Pylori IgM Antibody Serology, Helicobacter Pylori (Campylobacter Pylori), Serol Helicobac(S), Ulcer Antibody Test
Ordering Applications
Ordering Application Description
​Centricity ​Helicobacter pylori Ab, IgM (84408)
​Cerner None​
If the ordering application you are looking for is not listed, contact your local laboratory for assistance.
Specimen Requirements
Specimen Type Preferred Container/Tube Acceptable Container/Tube Specimen Volume Specimen Minimum Volume
(allows for 1 repeat)		 Pediatric Minimum Volume
(no repeat)
Serum​ ​Red Top Tube (RTT) ​Serum Separator Tube (SST) ​0.6 mL ​0.4 mL ​
Specimen Stability Information
Specimen Type Temperature Time
Serum​ Refrigerated (preferred)​ ​1days
​ ​Frozen ​14 days
Rejection Criteria
Hemolysis
Mild OK; Gross reject
​Lipemia
Mild OK; Gross reject
Useful For

Screening for Helicobacter pylori infection

This test will be obsoleted effective March 1st in effort to conform to current H pylori testing guidelines and to improve patient management. Both the American Gastroenterological Associationg and the American College of Gastroenterology recommend that serologic testing for H pylori be avoided as a means diagnosis of active H pylori infection due to the following limitations:

-poor positive predictive value (PPV)
-poor performance characteristics of these assays compared to alternative tests (MISC Mayo Codes UBT & HPSA)
-serologic testing cannot be used to distinguish active from past infection or to document eradication of the organism following successful treatment
-lack of reimbursement from an increasing number of insurance providers

To minimize improper diagnosis and unnecessary treatment regimens, providers are strongly encouranged to amend their testing strategies by replacing serologic evaluation of patients with suspected H pylori infection, with either the urea breath test (UBT) or stool antigen Test (HPSA).

Reference Range Information
Performing Location Reference Range
Mayo Medical Laboratories​​
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

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.

For more information visit:
Performing Laboratory Information
Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation
Mayo Medical Laboratories​​
 Monday through Friday; 9 a.m.
​
Same day/1 day
​
Enzyme-Linked Immunosorbent Assay (ELISA) 
Reference Lab
Mayo Clinic Laboratories
For billing questions, see Contacts
Outreach CPTs
CPT Modifier
(if needed)		 Quantity Description Comments
​86677 ​ ​ ​ ​
Classification

This test should be regarded as 'Research Use Only'. This test has not been cleared or approved by the U.S. Food and Drug Administration. It may not be covered by insurance and providers need to inform all patients of this prior to ordering. 

For Medicare patients, an Advanced Beneficiary notice (ABN) is required; for Medicaid patients, a Noncovered Services Waiver is required, and for commercial payers, prior authorization should be obtained.  

For most current information refer to the Marshfield Laboratory online reference manual.