title: An evaluation of the performance of a novel stick-type kit for rapid detection of Helicobacter pylori antibodies in urine.
abstract: BACKGROUND
  ODK-0702 is a stick-type urinary Helicobacter pylori (H. pylori) antibodies detection kit, developed to improve the original housing type urinary H. pylori antibodies detection kit "RAPIRUN H. pylori Antibody". This stick-type kit is designed for the efficient daily medical practice at hospital or clinic, public or school health checkup, to detect H. pylori infection. The aim of this study was to evaluate the performance and correlation of this kit with the original kit and the ELISA kit.
  
  
  METHODS
  Control kits were "RAPIRUN H. pylori Antibody" (Kit A) and "URINELISA H. pylori Antibody" (Kit B). Urine samples were obtained from 249 subjects scheduled for upper endoscopy, 99 subjects suspected of having upper gastrointestinal disease, and 150 subjects receiving health checkups. Rates of agreement in results between ODK-0702 and the control kits were investigated.
  
  
  RESULTS
  High agreement rates of 98.4% (245/249) and 88.8% (221/249) were found between ODK-0702 and the kits, Kit A and B, respectively. In patients, the agreement rates of ODK-0702 as compared to Kit A and B were 99.0% (98/99) and 88.9% (88/99), respectively. In control subjects, the agreement rates of ODK-0702 as compared to Kit A and B were 98.0% (147/150) and 88.7% (133/150), respectively.
  
  
  CONCLUSIONS
  ODK-0702 enabled rapid testing within 15 minutes and showed equivalent performance as control kits, being clinically very useful in the diagnosis of H. pylori infection.
authors: Department of General Medicine, Faculty of Medicine, Oita University, Oita, Japan. murakam@oita-u.ac.jp
authors: Kazunari
authors: K
authors: Murakami
authors: Tomoari
authors: T
authors: Kamada
authors: Hiroki
authors: H
authors: Ishikawa
authors: Hiroshi
authors: H
authors: Imamura
authors: Hiroshi
authors: H
authors: Matsumoto
authors: Minoru
authors: M
authors: Fujita
authors: Ken-Ichi
authors: K
authors: Tarumi
authors: Akiko
authors: A
authors: Shiotani
authors: Kazuhiro
authors: K
authors: Mizukami
authors: Seiji
authors: S
authors: Shiota
authors: Tadayoshi
authors: T
authors: Okimoto
authors: Masaaki
authors: M
authors: Kodama
authors: Ayako
authors: A
authors: Akiyoshi
authors: Tetsuya
authors: T
authors: Oda
authors: Atsunari
authors: A
authors: Noda
authors: Jiro
authors: J
authors: Hata
authors: Ken
authors: K
authors: Haruma
authors: Toshio
authors: T
authors: Fujioka
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000907:Antibodies, Bacterial / Q000276:immunology / Q000652:urine*; D003429:Cross Reactions; D005188:False Negative Reactions; D005260:Female; D005756:Gastritis / Q000175:diagnosis* / Q000382:microbiology / Q000652:urine; D016481:Helicobacter Infections / Q000175:diagnosis* / Q000652:urine; D016480:Helicobacter pylori / Q000276:immunology*; D006801:Humans; D007074:Immunoglobulin G / Q000276:immunology / Q000652:urine*; D008297:Male; D008875:Middle Aged; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D055815:Young Adult
chemical_list: D000907:Antibodies, Bacterial; D007074:Immunoglobulin G; D011933:Reagent Kits, Diagnostic