Accuracy of Four Commercially Available Serologic Tests, Including Two Office‐based Tests and a Commercially Available 13C Urea Breath Test, for Diagnosis of Helicobacter pylori

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Abstract
Background. Diagnosis of H. pylori infection may be made by endoscopic (invasive) tests, or by nonendoscopic (noninvasive) tests. Our aim was to evaluate recently available nonendoscopic tests, including two office‐based serologic tests and a commercially available 13C urea breath test. Methods. Gastric biopsy specimens (for culture and stain) from 178 patients (mean age 46 ± 13.3 years, 79 men and 99 women), none of whom had received anti‐H. pylori therapy, were tested for H. pylori infection. These tests were compared against two commercial serum IgG antibody immunoassays (Biowhittaker’s Pyloristat, and Quidel), 2 office‐based serum qualitative IgG antibody tests (FlexSure HP, and QuickVue One‐Step), the Meretek 13C urea breath test, and the CLOtest (a biopsy urease test). Results. The breath test (n = 147) had the best accuracy (96%) of the noninvasive tests studied. The serologic tests had similar accuracy to one another (84%–90%). The major drawback of the serologic tests was suboptimal specificity (75%–87%). Diagnosis of H. pylori based on the two office‐based tests were not significantly different compared to the quantitative IgG antibody tests. The CLOtest had an accuracy of 97%. Conclusions. The Meretek 13C urea breath test is an excellent test, but is considerably more expensive than serologic tests. The FlexSure HP and the QuickVue One‐Step office‐based qualitative IgG serologic antibody tests gave similar results to laboratory based quantitative antibody tests, and are acceptable for initial diagnosis of H. pylori infection. The advantages of the office‐based tests are low cost, simplicity, and immediacy of results.

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