Evaluation of a new rapid immunoassay for the detection of Helicobacter pylori in faeces: a prospective pilot study.
BACKGROUND
Detection of Helicobacter pylori antigen in faeces is a valid method to diagnose H. pylori infection. Presently available stool tests are performed in the laboratory, and diagnostic report is delayed.


OBJECTIVE
To evaluate a new rapid stool test in a pre-treatment setting and to compare it with a validated laboratory stool test.


METHODS
A total of 105 patients underwent gastroscopy with brush cytology, and biopsies for histology and rapid urease test, to assess H. pylori presence. Helicobacter pylori-status was considered positive if at least two tests were positive; negative if all tests were negative; indeterminate if one test was positive and two negative. Stool specimens were tested using either a rapid immunoassay kit (ImmunoCard STAT) or a laboratory enzyme immunoassay kit (Hp StAR).


RESULTS
Sixty patients were infected with H. pylori, 44 non-infected, one indeterminate. The sensitivity and specificity of ImmunoCard STAT were 85 and 93%; those of Hp StAR were 88 and 100% (not significant).


CONCLUSIONS
ImmunoCard STAT seems a reliable method for detecting H. pylori in untreated patients. It could replace laboratory stool tests, as it is easy and can be performed quickly. These characteristics might be a breakthrough for diagnosing H. pylori in the doctor's office.
Trevisani
L
L
Digestive Endoscopy Centre, Medical Department, S. Anna Hospital, Ferrara, Italy. tvl@unife.it
Sartori
S
S
Rossi
M R
MR
Ruina
M
M
Matarese
V
V
Gullini
S
S
Abbasciano
V
V
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000942:Antigens, Bacterial / Q000032:analysis; D004812:Epidemiologic Methods; D005243:Feces / Q000382:microbiology*; D005260:Female; D016481:Helicobacter Infections / Q000175:diagnosis*; D016480:Helicobacter pylori / Q000276:immunology / Q000302:isolation & purification*; D006801:Humans; D007118:Immunoassay / Q000379:methods; D007124:Immunoenzyme Techniques; D008297:Male; D008875:Middle Aged; D011933:Reagent Kits, Diagnostic
D000942:Antigens, Bacterial; D011933:Reagent Kits, Diagnostic