From the Guidelines
The H. pylori Antibody Immunoglobulin M (IgM) test is not recommended for diagnostic purposes due to its low specificity and sensitivity. The test is intended to detect acute or recent Helicobacter pylori infections by measuring immunoglobulin M (IgM) antibodies produced in response to an initial H. pylori infection 1. However, according to the latest evidence, IgM anti–H. pylori tests are generally not approved by the US Food and Drug Administration (FDA) and are not recommended because of their low specificity and sensitivity 1.
Some key points to consider when evaluating the use of the H. pylori Ab IgM test include:
- The test may be used to detect acute infections, but its low specificity and sensitivity limit its usefulness 1
- The presence of IgM antibodies typically indicates a recent infection, but this test alone may not provide complete diagnostic information for chronic infections
- Other diagnostic methods, such as IgG antibody tests, stool antigen tests, urea breath tests, or endoscopic biopsies, are generally preferred for comprehensive H. pylori diagnosis 1
- The use of non-FDA-approved tests, including panels of IgG, IgA, and IgM tests, is not recommended due to their unclear diagnostic value 1
In clinical practice, it is recommended to use FDA-approved tests, such as urea breath tests or stool antigen tests, to confirm the presence of an active H. pylori infection 1. These tests are more accurate and reliable than the IgM test, and they can provide a more comprehensive diagnosis of H. pylori infection.
From the Research
Purpose of the Helicobacter pylori (H. pylori) Antibody Immunoglobulin M (IgM) test
- The H. pylori Antibody IgM test is used to detect the presence of IgM antibodies against H. pylori in the blood [ 2, 3].
- The test is useful in diagnosing acute H. pylori infections, as IgM antibodies are typically present in the early stages of infection [ 3 ].
- The test can also be used to distinguish between acute and chronic infections, as IgM antibodies are usually not present in chronic infections [ 3 ].
- The sensitivity and specificity of the IgM test vary, but it has been shown to be a useful diagnostic tool in certain clinical situations [ 2, 3].
- The test is often used in conjunction with other diagnostic tests, such as the urea breath test, stool antigen test, and endoscopy, to confirm the diagnosis of H. pylori infection [ 4, 5,6].
Clinical Applications
- The H. pylori Antibody IgM test is used in clinical practice to diagnose H. pylori infections in patients with symptoms such as gastritis, gastric ulcer, and dyspepsia [ 5, 6].
- The test is also used in epidemiological studies to investigate the prevalence of H. pylori infections in different populations [ 6 ].
- The test can be used to monitor the effectiveness of treatment for H. pylori infections, as the presence of IgM antibodies can indicate a recent infection [ 3 ].