title: Good diagnostic accuracy of a chemiluminescent immunoassay in stool samples for diagnosis of Helicobacter pylori infection in patients with dyspepsia.
abstract: Laboratory-based chemiluminescence immunoassays (CLIA) are widely used in clinical laboratories. Some years ago, a CLIA test was developed for the detection of Helicobacter pylori in stool samples, known as LIAISON H. pylori SA, but little information on its use has been reported. To evaluate the accuracy of the LIAISON H. pylori SA assay for diagnosing H. pylori infection prior to eradication treatment. Diagnostic reliability was evaluated in 252 untreated consecutive patients with dyspepsia. The gold standard for diagnosing H. pylori infection was defined as the concordance of the rapid urease test (RUT), histopathology and urea breath test (UBT). The CLIA assay was performed according to the manufacturer's instructions. Sensitivity, specificity, positive and negative predictive values, and 95% CIs were calculated. According to the gold standard selected, 121 patients were positive for H. pylori infection and 131 negative. LIAISON H. pylori SA had a sensitivity of 90.1% and a specificity of 92.4%, with positive and negative predictive values of 91.6% and 90.1%, respectively. The accuracy of the LIAISON H. pylori SA chemiluminescent diagnostic assay seems comparable to that of ELISA or the best-performing LFIAs. Its sensitivity and specificity, however, seem slightly lower than those of histology, RUT or UBT. The advantages of the assay are that it is cheap, automated, and minimally labor-intensive.
authors.affiliation: Digestive Diseases Service, Hospital de Sabadell, Corporació Sanitària Parc Taulí, Institut Universitari Parc Taulí-UAB, Sabadell, Spain Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain Fundació Parc Taulí, Corporació Sanitària Parc Taulí, Institut Universitari Parc Taulí-UAB, Sabadell, Spain.
authors.forename: María José
authors.initials: MJ
authors.lastname: Ramírez-Lázaro
authors.affiliation: Service of Microbiology, CatLab, Viladecavalls, Barcelona, Spain.
authors.forename: Josep
authors.initials: J
authors.lastname: Lite
authors.affiliation: Digestive Diseases Service, Hospital de Sabadell, Corporació Sanitària Parc Taulí, Institut Universitari Parc Taulí-UAB, Sabadell, Spain Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain Fundació Parc Taulí, Corporació Sanitària Parc Taulí, Institut Universitari Parc Taulí-UAB, Sabadell, Spain.
authors.forename: Sergio
authors.initials: S
authors.lastname: Lario
authors.affiliation: Service of Microbiology, CatLab, Viladecavalls, Barcelona, Spain.
authors.forename: Pepa
authors.initials: P
authors.lastname: Pérez-Jové
authors.affiliation: Digestive Diseases Service, Hospital de Sabadell, Corporació Sanitària Parc Taulí, Institut Universitari Parc Taulí-UAB, Sabadell, Spain Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain.
authors.forename: Antònia
authors.initials: A
authors.lastname: Montserrat
authors.affiliation: Digestive Diseases Service, Hospital de Sabadell, Corporació Sanitària Parc Taulí, Institut Universitari Parc Taulí-UAB, Sabadell, Spain Fundació Parc Taulí, Corporació Sanitària Parc Taulí, Institut Universitari Parc Taulí-UAB, Sabadell, Spain.
authors.forename: María Elisa
authors.initials: ME
authors.lastname: Quílez
authors.affiliation: Digestive Diseases Service, Hospital de Sabadell, Corporació Sanitària Parc Taulí, Institut Universitari Parc Taulí-UAB, Sabadell, Spain Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain.
authors.forename: Eva
authors.initials: E
authors.lastname: Martínez-Bauer
authors.affiliation: Digestive Diseases Service, Hospital de Sabadell, Corporació Sanitària Parc Taulí, Institut Universitari Parc Taulí-UAB, Sabadell, Spain Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain Departament de Medicina. Facultat de Medicina, Universitat Autònoma de Barcelona, Barcelona, Spain.
authors.forename: Xavier
authors.initials: X
authors.lastname: Calvet
mesh_terms: D004415:Dyspepsia / Q000150:complications*; D005243:Feces / Q000382:microbiology*; D005260:Female; D016481:Helicobacter Infections / Q000150:complications / Q000175:diagnosis* / Q000382:microbiology*; D016480:Helicobacter pylori / Q000302:isolation & purification*; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D008163:Luminescent Measurements / Q000379:methods*; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D012015:Reference Standards; D012680:Sensitivity and Specificity
keywords: Inflammation; Stomach