HUITAI rapid urease test: a new ultra-rapid biopsy urease test for the diagnosis of Helicobacter pylori infection.

摘要

BACKGROUND: The gastric biopsy urease test is an accurate and robust diagnostic test for Helicobacter pylori infection. Large endoscopy units use their own homemade unbuffered ultra-rapid urease test for diagnosis of H. pylori infection but several commercial rapid urease tests are available. OBJECTIVE: To compare the accuracy and reaction time of a new biopsy urease test, HUITAI rapid urease test, in the diagnosis of H. pylori infection. METHODS: Consecutive patients presenting with dyspepsia to the endoscopy unit, University of Malaya Medical Center were recruited for the study. Patients who were previously treated for H. pylori infection or who had received antibiotics, proton pump inhibitors or bismuth compounds in the preceding 4 weeks were excluded. The H. pylori diagnosis was made based on the homemade rapid urease test, histology and culture of gastric biopsies. Biopsies from the antrum and corpus of the stomach were taken for this purpose. In addition, two antral and corpus biopsies were takenfor the HUITAI rapid urease test. A positive diagnosis of H. pylori infection was made when the culture was positive or if both histology and the rapid urease test were positive. A negative diagnosis was made when all tests were negative. The positive reaction time of the HUITAI rapid urease test was carefully timed up to 60 min. RESULTS: Two hundred and six patients were recruited in the study. One hundred and twelve were diagnosed as having an H. pylori infection while the other 94 patients were regarded as negative. There were no spoiled tests and no indeterminate results. The sensitivity of the HUITAI rapid urease test was 98.2% (95% confidence interval (CI): 93.7%, 99.8%), specificity, 99.0% (95% CI: 94.2%, 100%), positive predictive value, 99.0% (95% CI: 95.1%, 100%), negative predictive value, 97.9% (95% CI: 92.6%, 99.7%). The overall diagnostic accuracy for the HUITAI rapid urease test was 98.5% (95% CI: 96.6, 99.9). The median positive reaction time was 1.0 min (25-75% inter-quartile range [IQR]: 1.0-3.0 min). CONCLUSIONS: The HUITAI rapid urease test is highly accurate for the diagnosis of an H. pylori infection and showed a very rapid positive reaction time.