A rapid immunochromatographic assay for Helicobacter pylori in stool before and after treatment.
BACKGROUND
Current guidelines recommend non-invasive testing and treatment of young dyspeptic patients without alarm symptoms.


OBJECTIVE
To evaluate the accuracy of a new rapid immunochromatographic stool test to diagnose Helicobacter pylori infection before and after treatment compared with a gold standard.


METHODS
Prospective, single-blind study, performed in a tertiary care hospital. A total of 303 consecutive dyspeptic patients underwent endoscopy with multiple biopsies. Infected patients were offered a treatment and invited to come back 4-6 weeks after the end of therapy to repeat the endoscopy. Patients were also asked to provide a stool sample before and after therapy.


RESULTS
About 149 patients were H. pylori infected. The sensitivity and specificity before treatment were 91.3 and 93.5%; after treatment 92 and 100%. The likelihood ratios were robust enough to produce significant changes from pretest to post-test probability both in pre-treatment (LR+ = 14, LR- = 0.093) and post-treatment (LR+ = 19.6, LR- = 0.095).


CONCLUSIONS
The novel immunochromatographic stool test is fast, easy to perform and provides good differentiation between positive and negative results. It might become a rapid near patients test easily performed in the doctor office.
Department of Internal Medicine and Gastroenterology, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy.
L
L
Gatta
F
F
Perna
C
C
Ricci
J F
JF
Osborn
A
A
Tampieri
V
V
Bernabucci
M
M
Miglioli
D
D
Vaira
D000942:Antigens, Bacterial / Q000032:analysis*; D001706:Biopsy / Q000592:standards; D002845:Chromatography / Q000592:standards; D016099:Endoscopy, Gastrointestinal / Q000592:standards; D005243:Feces / Q000382:microbiology*; D005260:Female; D016481:Helicobacter Infections / Q000175:diagnosis* / Q000188:drug therapy; D016480:Helicobacter pylori / Q000302:isolation & purification*; D006801:Humans; D007159:Immunologic Tests / Q000592:standards*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D016037:Single-Blind Method
D000942:Antigens, Bacterial