Diagnostic Testing Accuracy in a High-Prevalence Native American Population of Northern Arizona.

( is a common gastric pathogen and a leading cause of non-cardia gastric cancers. Known determinants can affect the diagnostic accuracy of invasive clinical methods for diagnosis. The objective of this study was to determine the diagnostic accuracy of the CLOtest, a rapid urease test, and the histopathologic examination compared with polymerase chain reaction (PCR) in esophagogastroduodenoscopy patients from a population with high prevalence and other risk factors that may influence diagnostic accuracy. From 2018 to 2022, patients were recruited from a medical care center serving the southwestern Navajo Nation. Summary statistics were calculated using PCR as the comparator to the CLOtest and histopathologic examination. Among the 466 study participants, 27.1% (95% CI 22.9, 31.7%) tested positive for using PCR to detect pathogen DNA. Sensitivity was lowest for the CLOtest (57.0%; 95% CI 45.8, 67.6) and highest for the combination the CLOtest and histopathology (72.2%; 95% CI 62.8, 80.4). Patient history of infection or possible GI bleeding influenced sensitivity by over 5%. In high prevalence areas, emphasis should be placed on ensuring adequate treatment of suspected positive infections as false-positive results were rare. Including a more sensitive test might reduce the number of individuals falsely classified as negative.