Non-invasive diagnosis of Helicobacter pylori infection: simplified 13C-urea breath test, stool antigen testing, or DNA PCR in human feces in a clinical laboratory setting?
OBJECTIVE
(1) To compare two stool antigen EIAs (HpSA, FemtoLab) and PCR of ureaseA and cagA in feces, with (13)C-urea breath test (UBT). (2) To ascertain whether a simplified UBT (breath collection time = 10 min) is as reliable as the standard assay (30 min).


METHODS
Helicobacter pylori status was recorded in Group 1 (n = 187) by UBT, H. pylori stool antigen, ureA and cagA PCR in feces. UBT with 10, 20 and 30 min sampling was performed in Group 2 patients (n = 283).


RESULTS
The sensitivity and specificity of HpSA, FemtoLab, and ureA were 67% and 99%, 90% and 96%, 35% and 98%, respectively. cagA results were positive in 16/48 H. pylori-positive, and in 5/100 H. pylori-negative patients. The results of UBT with a 10- and 30-min sampling strictly overlapped.


CONCLUSIONS
UBT with 10 min breath collection and FemtoLab stool antigen assay are the most reliable non-invasive tests to diagnose H. pylori infection.
Department of Medical and Surgical Sciences, University of Padova, Italy.
Carlo-Federico
CF
Zambon
Daniela
D
Basso
Filippo
F
Navaglia
Saverio
S
Mazza
Monica
M
Razetti
Paola
P
Fogar
Eliana
E
Greco
Nicoletta
N
Gallo
Fabio
F
Farinati
Massimo
M
Rugge
Mario
M
Plebani
D000328:Adult; D000368:Aged; D000942:Antigens, Bacterial / Q000032:analysis* / Q000235:genetics / Q000276:immunology; D001426:Bacterial Proteins / Q000235:genetics; D001944:Breath Tests / Q000379:methods*; D002247:Carbon Isotopes; D019963:Clinical Chemistry Tests / Q000379:methods*; D004269:DNA, Bacterial / Q000032:analysis* / Q000235:genetics; D005243:Feces / Q000382:microbiology*; D005260:Female; D016481:Helicobacter Infections / Q000175:diagnosis* / Q000276:immunology / Q000382:microbiology; D016480:Helicobacter pylori / Q000201:enzymology / Q000235:genetics / Q000302:isolation & purification; D006801:Humans; D008297:Male; D008875:Middle Aged; D016133:Polymerase Chain Reaction; D012680:Sensitivity and Specificity; D014508:Urea; D014510:Urease / Q000235:genetics
D000942:Antigens, Bacterial; D001426:Bacterial Proteins; D002247:Carbon Isotopes; D004269:DNA, Bacterial; C080866:cagA protein, Helicobacter pylori; D014508:Urea; D014510:Urease