The Patterns and Associated Cost of Serologic Testing for Helicobacter pylori in the U.S. Military Health System.

INTRODUCTION Helicobacter pylori (H. pylori) infection affects about half of the world's population and can lead to multiple complications if left untreated. Testing for H. pylori infection in appropriate patients with prompt treatment followed by the testing of eradication is the standard of care in the United States. Active Duty Service members (ADSMs) in the U.S. military are a unique patient population that may be at higher risk for acquiring H. pylori infection given frequent deployments to developing countries. Noninvasive diagnostic strategies include the urea breath test, the stool antigen test, and serologic testing, which include H. pylori immunoglobulin M (IgM), immunoglobulin A (IgA), and immunoglobulin G (IgG) antibodies. Among noninvasive methods, the least sensitive is serology, and although there is clinical utility in testing for H. pylori IgG antibodies, H. pylori IgA or IgM antibodies have limited clinical utility. Despite this, H. pylori IgA and IgM antibodies are still widely ordered across the Military Health System. MATERIALS AND METHODS In order to determine how frequently this testing is being ordered and the associated cost, we conducted a retrospective cross-sectional study of H. pylori serologic testing utilization in the MHS from October 2015 to September 2018 in adult patients using the MHS Data Repository. All H. pylori IgM, IgA, and IgG antibodies, H. pylori stool antigen tests, and H. pylori urea breath tests were queried during this time period across all ADSMs, retirees, and ADSM dependents for all adults. Cost information was obtained from LabCorp, and the institutional price used for cost analysis was the same throughout all military treatment facilities in the Department of Defense (DOD). RESULTS We discovered that over a 3-yr period, 1,916 H. pylori IgA and 2,492 IgM antibodies were ordered. In total, the DOD spent close to $400,000 on antibody-based testing for H. pylori not accounting for indirect associated costs like personnel, supplies, repeat testing, as well as the costs of delayed diagnosis and associated complications. CONCLUSION H. pylori IgM and IgA have limited clinical utility, are inaccurate, and are costly to maintain, especially when more accurate alternative tests are available. Based on our analysis, we strongly recommend the removal of the H. pylori IgA and IgM serologic tests throughout the DOD in order to improve the efficiency and quality of care for patients suspected of having an H. pylori infection. Further research is needed to determine how these tests are ordered, how providers are responding to the results of the serologic tests, and if noninvasive testing is being ordered appropriately.