Prospective evaluation of a new urea-membrane test for the detection of Helicobacter pylori in gastric antral tissue.
OBJECTIVE
To determine the sensitivity, specificity, and positive and negative predictive values of a newly developed urea-membrane test for the detection of Helicobacter pylori in gastric tissue.


METHODS
Patients presenting for upper endoscopy with no recent exposure to H. pylori-altering drugs were enrolled. Antral biopsy specimens were tested by the urea-membrane and urea-gel methods and submitted for histology. Patients underwent [13C]urea breath tests. Presence of H. pylori was established by histology or the combination of a positive [13C]urea breath test and a positive urea-gel test. Absence of H.pylori required both the [13C]urea breath test and the invasive tests to be negative. The urea-membrane test was reported at 1 hour.


RESULTS
Ninety-nine patients (47 men and 52 women) with a mean age of 51.43 +/- 14.9 years participated. Fifty of 99 patients (prevalence, 50.5%) tested positive for H. pylori. The urea-membrane test correctly identified 49 of 50 H. pylori-positive and 46 of 49 H. pylori-negative patients, yielding sensitivity, specificity, and positive and negative predictive values of 98.0%, 93.9%, and 94.2% and 97.9%, respectively, in this population.


CONCLUSIONS
Rapidly available and reliable results from the urea-membrane test can facilitate clinical decision prior to patient discharge from the endoscopy suite.
Young
E L
EL
Section of Gastroenterology, Sinai Hospital, Detroit, Michigan 48235, USA.
Sharma
T K
TK
Cutler
A F
AF
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001706:Biopsy; D001944:Breath Tests; D016099:Endoscopy, Gastrointestinal; D005069:Evaluation Studies as Topic; D005260:Female; D016480:Helicobacter pylori / Q000302:isolation & purification*; D006801:Humans; D008297:Male; D008567:Membranes, Artificial; D008875:Middle Aged; D011446:Prospective Studies; D011706:Pyloric Antrum / Q000382:microbiology*; D012680:Sensitivity and Specificity; D014508:Urea
D008567:Membranes, Artificial; D014508:Urea