Helicobacter pylori Antibodies, IgM

CPT: 86677
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Test Details

Synonyms

  • Anti-Campylobacter Antibodies, IgM
  • Anti-H pylori, IgM

Use

Diagnose early H pylori infection in patients with gastric and duodenal disease. Circulating antibodies to H pylori are predominantly of the IgG class. A systemic response of the IgA type is usually less pronounced but, if significant, may indicate a more severe inflammation. A few patients develop only antibodies to IgA. Antibodies to IgM, although rare, may indicate an early infection.

Limitations

This test was developed, and its performance characteristics determined, by LabCorp. It has not been cleared or approved by the US Food and Drug Administration (FDA). Results of this test are for investigational purposes only. The results should not be used as a diagnostic procedure without confirmation of the diagnosis by another medically diagnostic product or procedure.

Methodology

Enzyme-linked immunosorbent assay (ELISA)

Reference Interval

• Negative: <9.0 units

• Equivocal: 9.0−11.0 units

• Positive: >11.0 units

Additional Information

Current studies suggest that H pylori IgM testing should be performed concomitantly with IgA and IgG tests for associated diagnosis of H pylori.

Specimen Requirements

Specimen

Serum

Volume

1 mL

Minimum Volume

0.5 mL

Container

Red-top tube or gel-barrier tube

Storage Instructions

Refrigerate.

Stability Requirements

Temperature

Period

Room temperature

7 days

Refrigerated

14 days

Frozen

14 days

Freeze/thaw cycles

Stable x3

Causes for Rejection

Heat inactivated serum; hemolysis; lipemia; gross bacterial contamination

Clinical Information

References

Kosunen TU, Seppälä K, Sarna S, Sipponen P. Diagnostic value of decreasing IgG, IgA, and IgM antibody titres after eradication of Helicobacter pylori.Lancet. 1992 Apr 11; 339(8798):893-895. 1348298
Thomson ABR. Helicobacter pylori and gastroduodenal pathology. Can J Gastroenterol. 1993; 7(4):353-358.
von Wulffen H. An assessment of serological tests for the detection of Helicobacter pylori.Eur J Clin Microbiol Infect Dis. 1992 Jul; 11(7):577-582.1396763

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
163204 Helicobacter pylori, IgM Ab 7903-8 163208 H pylori, IgM Abs units 7903-8
Reflex Table for H pylori, IgM Abs
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 163209 Disclaimer: 163209 Disclaimer: N/A

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