title: Accuracy of monoclonal stool tests for determining cure of Helicobacter pylori infection after treatment.
abstract: BACKGROUND
  Studies comparing new monoclonal fecal tests for evaluating cure of Helicobacter pylori infection after treatment are scarce. The objective was to compare the diagnostic accuracy of three monoclonal stool tests: two rapid in-office tools -RAPID Hp StAR and ImmunoCard STAT! HpSA - and an EIA test - Amplified IDEIA Hp StAR.
  
  
  METHODS
  Diagnostic reliability of the three tests was evaluated in 88 patients at least 8 weeks after H. pylori treatment. Readings of immunochromatographic tests were performed by two different observers. Sensitivity, specificity, positive and negative predictive values and 95% confidence intervals were calculated.
  
  
  RESULTS
  All tests presented similar performance for post-eradication testing. Sensitivity for detecting persistent infection was 100% for both Amplified IDEIA and RAPID Hp StAR and 90% for ImmunoCard STAT! HpSA. Respective specificities were 94.9%, 92.3-93.6% and 94.9%. Negative predictive values were very high (100%, 100% and 98.7% respectively). But positive predictive values were lower, ranging from 62.5 to 71.4%.
  
  
  CONCLUSIONS
  All monoclonal fecal tests in this series presented similar performance in the post-treatment setting. A negative test after treatment adequately predicted cure of the infection. However, nearly a third of tests were false positive, showing a poor predictive yield for persistent infection.
authors.affiliation: Hospital de Sabadell, Institut Universitari Parc Taulí, Departament de Medicina, Universitat Autònoma de Barcelona, Spain. xcalvet@tauli.cat <xcalvet@tauli.cat>
authors.forename: Xavier
authors.initials: X
authors.lastname: Calvet
authors.forename: Sergio
authors.initials: S
authors.lastname: Lario
authors.forename: María José
authors.initials: MJ
authors.lastname: Ramírez-Lázaro
authors.forename: Antònia
authors.initials: A
authors.lastname: Montserrat
authors.forename: Mariela
authors.initials: M
authors.lastname: Quesada
authors.forename: Lynsey
authors.initials: L
authors.lastname: Reeves
authors.forename: Helen
authors.initials: H
authors.lastname: Masters
authors.forename: David
authors.initials: D
authors.lastname: Suárez-Lamas
authors.forename: Marta
authors.initials: M
authors.lastname: Gallach
authors.forename: Mireia
authors.initials: M
authors.lastname: Miquel
authors.forename: Eva
authors.initials: E
authors.lastname: Martínez-Bauer
authors.forename: Isabel
authors.initials: I
authors.lastname: Sanfeliu
authors.forename: Ferran
authors.initials: F
authors.lastname: Segura
mesh_terms: D000328:Adult; D000368:Aged; D000907:Antibodies, Bacterial; D000911:Antibodies, Monoclonal; D016903:Drug Monitoring / Q000379:methods*; D005189:False Positive Reactions; D005243:Feces / Q000382:microbiology*; D005260:Female; D016481:Helicobacter Infections / Q000175:diagnosis* / Q000188:drug therapy; D016480:Helicobacter pylori / Q000302:isolation & purification*; D006801:Humans; D007118:Immunoassay; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D012680:Sensitivity and Specificity
chemical_list: D000907:Antibodies, Bacterial; D000911:Antibodies, Monoclonal