Applicability of a rapid stool antigen test, using monoclonal antibody to catalase, for the management of Helicobacter pylori infection.
BACKGROUND
Most monoclonal antibody-based stool antigen tests are of the "send-out" format. Rapid Testmate pylori antigen (Rapid TPAg) uses monoclonal antibody and is an "in-the-office" test. The aim of this study was to examine the usefulness of Rapid TPAg for the management of H. pylori infection.


METHODS
One-hundred and two consecutive patients who received H. pylori eradication therapy underwent both urea breath test (UBT) and Rapid TPAg at 5-6 weeks after finishing the eradication therapy. Stool samples were maintained at -20, 5, 25, and 40°C and subjected to Rapid TPAg after 1-7 days. Stool samples were also tested by enzyme immunoassay (EIA) to quantify antigenicity.


RESULTS
The agreement between Rapid TPAg and UBT in the evaluation of the results of H. pylori eradication treatment was 94.1%. The overall accuracy of Rapid TPAg and UBT to determine H. pylori eradication was 98.0 and 96.0%, respectively. The results of Rapid TPAg were not altered after storage of samples at -20 to 40°C for 7 days. Antigenicity quantified by EIA did not decrease significantly after 7 days.


CONCLUSIONS
Rapid TPAg is a useful diagnostic test for immediate and accurate determination of the results of H. pylori eradication therapy. The antigenicity of stool sample suspensions was preserved for 7 days in the collection devices.
Department of Gastroenterology, Hirosaki University Graduate School of Medicine, 5 Zaifu-cho, Hirosaki 036-8562, Japan. tsimo-hki@umin.ac.jp
Tadashi
T
Shimoyama
Manabu
M
Sawaya
Atsushi
A
Ishiguro
Norihiro
N
Hanabata
Tetsuro
T
Yoshimura
Shinsaku
S
Fukuda
D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use; D000911:Antibodies, Monoclonal / Q000276:immunology; D000942:Antigens, Bacterial / Q000032:analysis*; D001944:Breath Tests; D002374:Catalase / Q000276:immunology; D004359:Drug Therapy, Combination; D005243:Feces / Q000382:microbiology*; D005260:Female; D016481:Helicobacter Infections / Q000175:diagnosis* / Q000188:drug therapy; D016480:Helicobacter pylori / Q000302:isolation & purification*; D006801:Humans; D007124:Immunoenzyme Techniques; D008297:Male; D008875:Middle Aged; D054328:Proton Pump Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use; D015203:Reproducibility of Results; D013048:Specimen Handling / Q000379:methods; D013696:Temperature; D013997:Time Factors; D016896:Treatment Outcome; D014508:Urea
D000900:Anti-Bacterial Agents; D000911:Antibodies, Monoclonal; D000942:Antigens, Bacterial; D054328:Proton Pump Inhibitors; D014508:Urea; D002374:Catalase
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