Comparison between a new 13C-urea breath test, using a film-coated tablet, and the conventional 13C-urea breath test for the detection of Helicobacter pylori infection.
BACKGROUND
In Japan, urea breath-testing includes mouth rinsing with water immediately after the ingestion of (13)C-urea solution, to prevent false-positive results that are caused by oral bacteria with urease activity. Our objective was to evaluate the diagnostic performance of a urea breath test using a film-coated (13)C-urea tablet and omitting mouth rinsing.


METHODS
The study was a multicenter trial comparing the solution- and tablet-based urea breath tests (UBTs). Helicobacter pylori status was determined by histology, culture, and rapid urease testing.


RESULTS
Of the 255 subjects who completed the study, evaluation of the tablet-based UBT was possible in 254, and comparison of the tablet-based UBT and the solution-based UBT was possible in 250 patients. When the assessment achieved by a combination of biopsy-based methods was used as a reference standard, the sensitivity, specificity, and accuracy of the tablet-based method were determined to be 97.7%, 98.4%, and 98.0%, respectively. When the results of the solution-based UBT were used as a reference standard, the sensitivity, specificity, and accuracy of the tablet-based UBT were determined to be 96.9%, 97.6%, and 97.2%, respectively.


CONCLUSIONS
The (13)C-urea tablet-based method proved to be a simple and accurate test for the diagnosis of H. Pylori infection. Mouth rinsing was not required.
Health Administration Center, Tohoku University, Division of Gastroenterology, Tohoku University School of Medicine, 1-1 Seiryo-cho, Aoba-ku, Sendai 980-8574, Japan.
Shuichi
S
Ohara
Mototsugu
M
Kato
Masao
M
Saito
Shinsaku
S
Fukuda
Chieko
C
Kato
Shiro
S
Hamada
Ryuichi
R
Nagashima
Katsutoshi
K
Obara
Masayuki
M
Suzuki
Hirohito
H
Honda
Masahiro
M
Asaka
Takayoshi
T
Toyota
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001944:Breath Tests; D002247:Carbon Isotopes; D018592:Cross-Over Studies; D004378:Duodenal Diseases / Q000175:diagnosis* / Q000382:microbiology; D005260:Female; D016481:Helicobacter Infections / Q000175:diagnosis*; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D008875:Middle Aged; D012680:Sensitivity and Specificity; D012996:Solutions; D013272:Stomach Diseases / Q000175:diagnosis* / Q000382:microbiology; D013607:Tablets; D014508:Urea / Q000008:administration & dosage*
D002247:Carbon Isotopes; D012996:Solutions; D013607:Tablets; D014508:Urea