Immunochemistry, Test Utilization

Helicobacter Antibody Testing

Effective March 1, 2016, Mayo Medical Laboratories will no longer perform any Helicobacter Antibody (IgG, IgM, or IgA) testing. The Mayo Clinic has determined that Helicobacter antibody testing has a poor predictive value, and also has poor clinical sensitivity and specificity. While a negative antibody result suggests the absence of prior Helicobacter exposure, a positive result is not predictive of active Helicobacter infection. Furthermore, since antibody levels may remain positive for years following resolution of infection serologic testing cannot be used to distinguish active from past infection or document eradication of Helicobacter infection following treatment. See the full text of a recent Mayo Medical Laboratories Communique article on Helicobacter testing methods for further information on the various available tests for Helicobacter infection.

Effective as of the above date, the Helicobacter pylori Antibody IgM and Helicobacter pylori Antibody IgA tests will no longer be available through the Spectrum Health Laboratory. The Helicobacter pylori Antibody IgG test (#8596), which is performed in house, will continue to be available until further notice, but may be subject to further review at a later time. Some third party payers are now considering Helicobacter antibody tests to be medically unnecessary and no longer reimbursing for them.

The Helicobacter pylori breath test (#3013, available from the Spectrum Health Laboratory) and the Helicobacter pylori Antigen, Stool test (#4307, available as a send out to Mayo Medical Laboratories) are now considered the primary recommended tests for the diagnostic evaluation of suspected Helicobacter infection. Refer to the linked Mayo diagnostic algorithm for further information on recommended approaches to Helicobacter pylori diagnostic testing.

Any questions concerning these changes in Helicobacter pylori testing may be directed to Dr. Richard Horvitz in the Pathology Department.

 

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