Samples collected in a RTT or STT must be removed from cells within one hour for storage or transport.
Samples collected in gel barrier tubes must be removed from the primary tube prior to transporting to Marshfield. Do not send the primary collection tube.
A qualitative assay for the detection of IgG antibodies to Helicobacter.pylori (H.pylori). This test is not recommended as a diagnostic test in asymptomatic patients. About 25% of a normal population may be seropositive for antibodies to H. pylori. This is a sensitive method to determine colonization but does not differentiate between active infection and colonization. Helicobacter pylori antibodies are found in men and women at equal rates and presence of Helicobacter pylori antibodies increases with age.
Individuals with an acute H. pylori infection may not exhibit any detectable IgG antibodies at the early stage of infection. Antibody levels do not necessarily correlate with the severity of clinical symptoms. This testing is not adequate to determine if an infection has been eradicated as antibodies to H.pylori may persist several months after treatment.
Inaccurate results are more common in the elderly and in patients with cirrhosis in whom specificity can be compromised. As a result, other techniques may be preferred in these settings. Overall sensitivity and specificity of this assay may vary among different populations.
The performance characteristics of this assay have not been established for use with specimens from cord blood, neonates, pediatric patients, or pre-transplant patients.
A Negative test indicates that H. pylori IgG antibodies were not detected in the sample. Negative results by this test do not preclude recent primary infection as IgG antibodies may not be present at an early stage of H.Pylori infection.
A Positive test indicates that H. pylori IgG antibodies were detected in the sample. It does not necessarily indicate that any existing symptoms are due to H.pylori infection or colonization. It also does not differentiate between active and past infection.
Results reported as Indeterminate is retested. Repeated indeterminate samples should be examined by an alternate method, or retested with a repeat sample within a 7 to 10 days.
The H.pylori IgG antibodies results determined by different manufacturers can vary due to differences in assay methods and reagent specificity. Results obtained from other manufacturers' assay methods cannot be used interchangeably.