A rapid, low-dose, 13C-urea tablet for the detection of Helicobacter pylori infection before and after treatment.
BACKGROUND
A new urea breath test (UBT) has been described which uses a tablet formulation of 13C-urea with citric acid and allows breath sampling to be performed as early as 10 min after ingestion of the tablet.


OBJECTIVE
To assess the diagnostic accuracy of tablet-based 13C-UBTs (50 and 100 mg 13C-urea) before and after Helicobacter pylori eradication treatment, compared with an endoscopy gold standard and a conventional 13C-UBT (75 mg 13C-urea).


METHODS
Two hundred dyspeptic patients underwent endoscopy, followed by tablet-based 13C-UBTs (50 and 100 mg 13C-urea) and a conventional 13C-UBT (75 mg 13C-urea). H. pylori-infected patients were prescribed treatment and asked to return 4-6 weeks after the end of therapy for repeat endoscopy and 13C-UBTs.


RESULTS
One hundred and thirteen patients were infected with H. pylori. The sensitivity and specificity of the conventional 13C-UBT were both 100%; the sensitivity and specificity of the 100-mg tablet-based 13C-UBT were 100% and 98.85%, respectively. For the 50-mg tablet-based 13C-UBT, cut-off values of the difference over baseline of between 1.65 and 3.15 provided a sensitivity and specificity of 100%. At follow-up, the sensitivity and specificity of the conventional and 100-mg tablet-based 13C-UBTs were both 100%. For the 50-mg tablet-based 13C-UBT, cut-off values of the difference over baseline of between 1.49 and 1.56 gave a sensitivity and specificity of 100%.


CONCLUSIONS
New 10-min 13C-UBTs using tablet formulations of 13C-urea with citric acid are reliable for the assessment of H. pylori status pre- and post-treatment.
Gatta
L
L
Department of Internal Medicine and Gastroenterology, University of Bologna, Bologna, Italy.
Vakil
N
N
Ricci
C
C
Osborn
J F
JF
Tampieri
A
A
Perna
F
F
Miglioli
M
M
Vaira
D
D
D001706:Biopsy; D001944:Breath Tests; D005260:Female; D016481:Helicobacter Infections / Q000175:diagnosis*; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D013607:Tablets; D014508:Urea / Q000032:analysis
D013607:Tablets; D014508:Urea