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Test Name:
Helicobacter pylori IgM Antibody


  • SBMF No:
    28076
  • Performance Lab Name:
    Immunology
  • Test Mnemonic:
    H PYL IGM
  • ABN:
    Required – Not FDA-Approved
  • CPT Code:
    86677
  • LOINC Code:
    46987-4
  • Also Known As:
    H. pylori IgM Antibody
  • Spec Type:
    Serum
  • Spec Container:
    Gold top (SST) or red top (serum) tube
  • Pref Vol:
    1.0 mL
  • Min Vol:
    0.5 mL
  • Fasting:
    No
  • Spec Collect:
    Routine venipuncture
  • Spec Process:
    Clot 30 minutes
    Promptly centrifuge 15 minutes
    Immediately transfer serum to separate plastic tube
    Properly centrifuged gel barrier tube sample does not require transfer of serum to separate tube
  • Spec Store Transport:
    Refrigerated
  • Spec Stability:
    10 days refrigerated (2-8°C)
    Greater than 10 days, freeze (-20°C) – Do not use frost-free units that undergo repeated freeze/thaw cycles
  • Spec Reject:
    Severely hemolyzed, lipemic, icteric, or heat-inactivated specimen
  • Methodology:
    Enzyme-Linked Immunosorbent Assay (ELISA)
  • Use:
    Detect the presence of Helicobacter pylori IgM antibody, an early indicator of exposure to the organism
  • Clinical Significance:
    IgM is elevated during the early stages of an exposure to H. pylori. There are two possible outcomes, either the immune system will eradicate the organism or the organism will begin to populate the mucosal lining of the upper GI tract. If IgM is the only elevated antibody to H. pylori, it must be correlated with active symptoms to determine if treatment is required. If asymptomatic, it is quite possible that the immune system was able to counter the effects of infection. If treatment is not chosen at this time, it is recommended to retest the patient in 2-3 months to ensure that infection has subsided.
  • Reference Range:
    H Pylori IgM AB
    RANGEINTERPRETATION
    < or = 30.0 U/mL   Negative
    30.1 - 39.9 U/mL   Equivocal
    > or = 40.0 U/mL   Positive
  • Additional Test Info:
    This test was developed and its performance characteristics determined by South Bend Medical Foundation laboratory. It has not been cleared or approved by the U.S. Food and Drug Administration. The test is used for clinical purposes and should not be regarded as investigational or for research. SBMF is certified under CLIA as qualified to perform high complexity clinical laboratory testing.
  • Day Run:
    Tue
  • Time Run:
    7:00 am
  • Time Reported:
    5:00 pm
  • Test Type:
    INFECTIOUS ANTIBODY

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