The clinical applications and accuracy of 2 rapid near-patient tests in detecting Helicobacter pylori infection

Abstract

Noninvasive methods for assessing Helicobacter pylori infection status are now an integral part of managing patients with upper gastrointestinal complaints. The aim of this study is to evaluate the feasibility and diagnostic accuracy of 2 rapid tests: a urine-based H. pylori antibody detection method (Rapirun™) and a stool-based H. pylori antigen detection method (immunocard STAT! HpSA™). The combined use of the mentioned 2 tests was also evaluated, which has not been described in previous similar studies. Urine and stool specimens were collected from patients who were arranged for gastroendoscopic examination. The urine and stool specimens were tested with Rapirun™ and immunocard STAT! HpSA™ separately. The estimated reaction time was about 15 to 20 min for the former and 5 to 10 min for the latter. H. pylori infection was confirmed with 4 tests: culture, histology, rapid urease test, and the 13C-urea breath test. Obtained results from both kits were compared with confirmed results. One hundred twenty patients were eligible for analysis. Of them, 62 tested positive for H. pylori infection and 58 were negative by the confirmation criteria. The urine Rapirun™ test relative to the confirmed results showed sensitivity, specificity, and accuracy as 87.1% (confidence interval [CI] = 81.1–93.1%), 89.7% (CI = 84.2–95.1%), and 88.3%, respectively. The stool immunocard STAT! HpSA™ test relative to the confirmed results showed sensitivity, specificity, and accuracy as 96.8% (CI = 93.6–99.9%), 82.8% (CI = 76.0–89.5%), and 90%, respectively. The combined-use method of both tests revealed sensitivity, specificity, and accuracy as 98.4% (CI = 96.1–100%), 81.0% (CI = 74.0–88.1%), and 90%, respectively. These 2 urine and stool tests have a satisfactory accuracy around 90% in detecting H. pylori infection. In consideration of the advantages of cheapness, timesaving, and ease of use, both can be used as rapid near-patient tests in general practice. The combined use of both tests was also promising in detecting H. pylori infection.