title: Non-invasive diagnosis of Helicobacter pylori infection in adult dyspeptic patients by stool antigen detection: does the rapid immunochromatography test provide a reliable alternative to conventional ELISA kits?
abstract: Stool antigen-testing allows non-invasive detection of Helicobacter pylori that is indicative of active infection. Three commercial kits are currently marketed in the UK for stool antigen-testing. The aim of this study was to conduct a comparative evaluation of the performances of each of these tests, compared with culture and histological examination of gastric biopsies, for pre-treatment diagnosis of infection in an adult dyspeptic population in south-east England. Examination of 112 stool samples by the Premier Platinum HpSA ELISA (Meridian Diagnostics) and by the Amplified IDEIA HpStAR ELISA (DakoCytomation) kits demonstrated that the latter was more sensitive (81.3 versus 93.8%, respectively) and specific (91.7 versus 100.0%, respectively). Additionally, the IDEIA HpStAR was easier to interpret, with OD readings of positive and negative results being far from the recommended cut-off, whereas equivocal results that were generated by the HpSA kit were difficult to interpret. Additional testing of 87 of the 112 stools by the ImmunoCard STAT! HpSA kit (Meridian Diagnostics) demonstrated that this test was easier to perform than ELISA and was more sensitive than the HpSA kit but, compared with the IDEIA HpStAR kit, the ImmunoCard test was less sensitive (87.8 versus 95.9%, respectively) and specific (89.4 versus 100.0%, respectively). Furthermore, the ImmunoCard test generated weakly positive results, correlating with lower OD readings for both ELISA kits, that were difficult to interpret. The Amplified IDEIA HpStAR kit is therefore the most sensitive and specific of the three tests that are available for pre-treatment, non-invasive detection of H. pylori in stool samples in an English adult dyspeptic population.
authors.affiliation: Specialist and Reference Microbiology Division, 61 Colindale Avenue, Colindale, London NW9 5HT, UK 2Chelmsford Microbiology Laboratory, Chelmsford, UK 3Broomfield Hospital, Chelmsford, UK.
authors.forename: Stephanie A
authors.initials: SA
authors.lastname: Chisholm
authors.affiliation: Specialist and Reference Microbiology Division, 61 Colindale Avenue, Colindale, London NW9 5HT, UK 2Chelmsford Microbiology Laboratory, Chelmsford, UK 3Broomfield Hospital, Chelmsford, UK.
authors.forename: Claire L
authors.initials: CL
authors.lastname: Watson
authors.affiliation: Specialist and Reference Microbiology Division, 61 Colindale Avenue, Colindale, London NW9 5HT, UK 2Chelmsford Microbiology Laboratory, Chelmsford, UK 3Broomfield Hospital, Chelmsford, UK.
authors.forename: E Louise
authors.initials: EL
authors.lastname: Teare
authors.affiliation: Specialist and Reference Microbiology Division, 61 Colindale Avenue, Colindale, London NW9 5HT, UK 2Chelmsford Microbiology Laboratory, Chelmsford, UK 3Broomfield Hospital, Chelmsford, UK.
authors.forename: Seth
authors.initials: S
authors.lastname: Saverymuttu
authors.affiliation: Specialist and Reference Microbiology Division, 61 Colindale Avenue, Colindale, London NW9 5HT, UK 2Chelmsford Microbiology Laboratory, Chelmsford, UK 3Broomfield Hospital, Chelmsford, UK.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Owen
mesh_terms: D000328:Adult; D000368:Aged; D000942:Antigens, Bacterial / Q000032:analysis*; D001706:Biopsy; D002846:Chromatography, Affinity; D004415:Dyspepsia / Q000209:etiology*; D004739:England; D004797:Enzyme-Linked Immunosorbent Assay; D005188:False Negative Reactions; D005189:False Positive Reactions; D005243:Feces / Q000382:microbiology*; D005753:Gastric Mucosa / Q000382:microbiology / Q000473:pathology; D016481:Helicobacter Infections / Q000175:diagnosis*; D016480:Helicobacter pylori / Q000254:growth & development / Q000276:immunology / Q000302:isolation & purification*; D006801:Humans; D007158:Immunologic Techniques; D008875:Middle Aged; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity
chemical_list: D000942:Antigens, Bacterial; D011933:Reagent Kits, Diagnostic