title: Evaluation of a new rapid lateral flow chromatography test for the diagnosis of Helicobacter pylori.
abstract: OBJECTIVE
  The rapid, simple and non-invasive diagnosis of Helicobacter pylori (H. pylori) infection is important in implementing chemotherapy in appropriate manner, and in assessing persistent H. pylori infection after eradication therapy. The ImmunoCard STAT! HpSA kit (Meridian Bioscience, Europe) is a lateral flow chromatography test which utilizes a monoclonal anti-H. pylori antibody. In this study, we investigated the usefulness of the ImmunoCard STAT! HpSA test before and after eradication therapy on patients referred to undergo upper gastrointestinal endoscopy.
  
  
  METHODS
  Sixty-five consecutive patients who were referred to undergo upper gastrointestinal endoscopy at the Department of Gastroenterology, Karadeniz Technical University Medical School, Turkey between February and August 2005 were included in this study. The ImmunoCard STAT! HpSA was compared with 4 invasive tests (histology, gram staining, rapid urease test, and culture). The reference method was defined as positive when 2 of the 4 invasive tests were positive. A negative H. pylori status was considered when all 4 tests present concordant negative results.
  
  
  RESULTS
  Overall, the ImmunoCard STAT! HpSA test had 77.8% sensitivity, 79.3% specificity, 82.4% positive predictive value (PPV) and 74.2% negative predictive value (NPV) in all patients. With regard to pre-treatment values, the sensitivity was 70.6%, specificity 70.6%, PPV 100% and NPV 100% while on post-treatment group the sensitivity was 84.2%, specificity 64.7%, PPV 72.7% and NPV 78.6%.
  
  
  CONCLUSIONS
  Our results indicate that the ImmunoCard STAT! HpSA test is a rapid, simple, and helpful procedure not only to determine H. pylori infection but also to assess the success of eradication therapy.
authors.affiliation: Department of Microbiology, Karadeniz Technical University, Turkey. nkkaya@yahoo.com
authors.forename: Nese
authors.initials: N
authors.lastname: Kaklikkaya
authors.forename: Remzi A
authors.initials: RA
authors.lastname: Akdogan
authors.forename: Orhan
authors.initials: O
authors.lastname: Ozgur
authors.forename: Dogan Y
authors.initials: DY
authors.lastname: Uzun
authors.forename: Umit
authors.initials: U
authors.lastname: Cobanoglu
authors.forename: Ugur
authors.initials: U
authors.lastname: Dinc
authors.forename: Erdal
authors.initials: E
authors.lastname: Gungor
authors.forename: Pinar A
authors.initials: PA
authors.lastname: Dabanca
authors.forename: Mehmet
authors.initials: M
authors.lastname: Arslan
authors.forename: Faruk
authors.initials: F
authors.lastname: Aydin
authors.forename: Murat
authors.initials: M
authors.lastname: Erturk
mesh_terms: D000911:Antibodies, Monoclonal; D000942:Antigens, Bacterial / Q000032:analysis*; D002845:Chromatography / Q000379:methods; D005243:Feces / Q000382:microbiology*; D005260:Female; D016481:Helicobacter Infections / Q000175:diagnosis*; D016480:Helicobacter pylori / Q000276:immunology / Q000302:isolation & purification*; D006801:Humans; D007159:Immunologic Tests; D008297:Male; D008875:Middle Aged; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D014421:Turkey
chemical_list: D000911:Antibodies, Monoclonal; D000942:Antigens, Bacterial; D011933:Reagent Kits, Diagnostic