The stool antigen test for detection of Helicobacter pylori after eradication therapy.
BACKGROUND
Current noninvasive tests to confirm the eradication of Helicobacter pylori must be performed 4 weeks or more after eradication therapy is completed.


OBJECTIVE
To determine whether the stool antigen test, a relatively new noninvasive test for H. pylori, administered at various times after eradication therapy correctly identifies persons with persistent H. pylori infection.


METHODS
Prospective blinded study.


METHODS
Six clinical centers in the United States and Europe.


METHODS
84 H. pylori --infected patients undergoing endoscopy for upper abdominal symptoms.


METHODS
At baseline and on day 35 after the completion of triple eradication therapy, all patients underwent endoscopy with histologic examination, rapid urease test and culture, urea breath test, and a stool antigen test. The stool antigen test was also performed on days 3, 7, 15, 21, 28, and 35 after completion of therapy.


RESULTS
Compared with the gold-standard endoscopic tests on day 35 after antimicrobial therapy, the urea breath test had a sensitivity of 94% (95% CI, 71% to 100%) and a specificity of 100% (CI, 94% to 100%). The stool antigen test had a sensitivity of 94% (CI, 71% to 100%) and a specificity of 97% (CI, 89% to 100%). On day 7 after treatment, the stool antigen test was predictive of eradication (positive predictive value, 100% [CI, 69% to 100%]; negative predictive value, 91% [CI, 82% to 97%]).


CONCLUSIONS
A positive result on the stool antigen test 7 days after completion of therapy identifies patients in whom eradication of H. pylori was unsuccessful.
Vaira
Dino
D
Department of Internal Medicine and Gastroenterology, S. Orsola Hospital, via Massarenti 9, 40138 Bologna, Italy. vairadin@med.unibo.it
Vakil
Nimish
N
Menegatti
Marcello
M
van't Hoff
Ben
B
Ricci
Chiara
C
Gatta
Luigi
L
Gasbarrini
Giovanni
G
Quina
Mario
M
Pajares Garcia
Jose M
JM
van Der Ende
Arie
A
van Der Hulst
Rene
R
Anti
Marcello
M
Duarte
Cristina
C
Gisbert
Javier P
JP
Miglioli
Mario
M
Tytgat
Guido
G
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D000942:Antigens, Bacterial / Q000032:analysis*; D001944:Breath Tests; D004359:Drug Therapy, Combination; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D005243:Feces / Q000382:microbiology*; D005260:Female; D005756:Gastritis / Q000188:drug therapy / Q000382:microbiology*; D016481:Helicobacter Infections / Q000188:drug therapy / Q000382:microbiology*; D016480:Helicobacter pylori / Q000302:isolation & purification*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D016037:Single-Blind Method
D000900:Anti-Bacterial Agents; D000942:Antigens, Bacterial