title: Evaluation of a newly developed rapid stool antigen test using an immunochromatographic assay to detect Helicobacter pylori.
abstract: The ASAN Easy Test H. pylori is a newly developed rapid test for Helicobacter pylori that uses a stool antigen immunochromatographic assay (S-ICT). The aim of this study was to evaluate this kit for the diagnosis of H. pylori under various histological conditions. We enrolled 266 consecutive patients undergoing a routine health checkup and endoscopy with biopsy. H. pylori infection was confirmed if at least 2 out of the 3 following tests were positive: histology, real-time polymerase chain reaction (PCR), and the stool antigen test by enzyme immunoassay (S-EIA). Histological examination was performed using hematoxylin-eosin and silver staining. Real-time PCR was performed with a probe for the UreA gene as described previously. The S-EIA and the evaluated kit were used according to the manufacturers' instructions. Of the 266 patients, 209 were eligible for participation. The evaluation results were as follows: sensitivity, 84.5%; specificity, 96.2%; positive-predictive value, 95.6%; negative-predictive value, 86.4%; and accuracy, 90.4%. The performance of the kit was unaffected by histological findings such as atrophic gastritis, ulcers, and intestinal metaplasia. The newly developed S-ICT assay is a non-invasive rapid test for the diagnosis of H. pylori that exhibits good performance in routine health checkup patients.
authors: Department of Laboratory Medicine, The Catholic University of Korea, Seoul, Korea.
authors: Dong Wook
authors: DW
authors: Jekarl
authors: Yeon Ju
authors: YJ
authors: An
authors: Seungok
authors: S
authors: Lee
authors: Jehoon
authors: J
authors: Lee
authors: Yonggoo
authors: Y
authors: Kim
authors: Yeon-Joon
authors: YJ
authors: Park
authors: Tae Jung
authors: TJ
authors: Kim
authors: Jin Il
authors: JI
authors: Kim
authors: Soo-Heon
authors: SH
authors: Park
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000907:Antibodies, Bacterial / Q000276:immunology; D000911:Antibodies, Monoclonal / Q000276:immunology; D000942:Antigens, Bacterial / Q000032:analysis*; D002846:Chromatography, Affinity / Q000379:methods*; D005243:Feces / Q000382:microbiology; D005260:Female; D016481:Helicobacter Infections / Q000175:diagnosis* / Q000453:epidemiology / Q000382:microbiology; D016480:Helicobacter pylori / Q000276:immunology / Q000302:isolation & purification*; D006801:Humans; D007124:Immunoenzyme Techniques / Q000379:methods*; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D015995:Prevalence; D060888:Real-Time Polymerase Chain Reaction; D015203:Reproducibility of Results; D056910:Republic of Korea / Q000453:epidemiology; D012680:Sensitivity and Specificity; D013997:Time Factors; D014510:Urease / Q000235:genetics
chemical_list: D000907:Antibodies, Bacterial; D000911:Antibodies, Monoclonal; D000942:Antigens, Bacterial; D014510:Urease