The accuracy of the rapid urease test and 13C-urea breath test in the diagnosis of Helicobacter pylori infection

Abstract

Background: Helicobacter pylori (H. pylori) is an important predisposing factor in peptic ulcer disease. Many tests have been proposed, but there is no generally accepted single method for the detection of H. pylori. This study compared the four available methods in the detection of H. pylori.

Methods: One hundred and thirteen patients were studied with endoscopic biopsy. Biopsy specimens were examined with modified Giemsa stain and rapid urease (CLO) test. Serology (ELISA) and 13C-urea breath test (13C-UBT) were also performed. The 13C-UBT results were expressed at an excess delta 13CO2 excretion of 5 per mil as the upper limit. Multiple breath samples were collected 15, 30 and 60 minutes following 13C-urea ingestion (t = 15, 30, 60) in the first 60 patients. Gastric inflammatory changes were graded according to the Whitehead classification. The diagnostic gold standard was defined when three or more of the four test parameters showed positive.

Results: According to this diagnostic gold standard, the positive rates of H. pylori were 97.9% for duodenal ulcer, 81.8% for gastric ulcer, 47.6% for symptomatic gastritis and 13.6% for asymptomatics. Rapid urease test and the 13C-UBT had better sensitivity (93.6% and 96.2%) and accuracy (93.8% and 93.8%). The specificity and positive predictive value for rapid urease test was better than 13C-UBT (94.3% v.s. 88.6%, 97.3% v.s. 94.9% respectively). Modified Giemsa stain had the lowest sensitivity (87.2%), and the ELISA test had the lowest specificity (71.4%). Severity of the gastric inflammatory processes was directly correlated with the excess delta 13CO2 (r = 0.576).

Conclusions: Both the CLO and 13C-UBT had higher accuracy in the detection of H. pylori. When the CLO test result is positive, there is little additional diagnostic benefit from performing other tests. If patients refuse endoscopic examination, 13C-UBT is a good alternative for the detection of H. pylori, either during diagnosis or follow-up after therapy.