Prospective, study comparing the accuracy of two different stool antigen tests (Premier Platinum HpSA and novel ImmunoCard STATI rapid test) for the diagnosis of Helicobacter pylori infection
Por:
McNicholl AG, Garre A, Llorca L, Bujanda L, Molina-Infante J, Barenys M, Perez J, Guerrero-Torres MD, Tamayo E, Montes M, Prados-Manzano R, Sanchez-Garcia A, Ramas M, Valdez Blanco VB, Montoro M, Calvet X, Figuerola A, Lario S, Quilez E, Lanas A, Silva-Pomarino P, Perez-Aisa A, Donday MG, Belloc B, Montserrat-Torres A, Fernandez-Moreno N, Ramírez MJ, Alarcon T and Gisbert JP
Publicada:
1 mar 2020
Ahead of Print:
3 dic 2019
Resumen:
Background: At present only monoclonal EIA (enzyme-immunoassay) stool antigen-tests have obtained optimal accuracy in the diagnosis of Helicobacter pylori. Our aim was to evaluate the accuracy of two stool antigen-tests, the validated Premier Platinum HpSA PLUS (EIA test) and the newly available ImmunoCard STATI HpSA HD (rapid test) for the initial diagnosis and the confirmation of eradication of H. pylori infection.
Patients and methods: Patients with indication of H. pylori diagnosis, or confirmation after treatment were included. Data were coded to protect personal data and ensure blindness between tests. Accuracy was considered as coincident diagnosis with the gold standard (C-13-urea breath test, UBT). The EIA was used as a bench standard. All stool tests were performed in duplicate.
Results: 264 patients completed the protocol (100 naive, 164 post-eradication). Average age was 52 years, 61% women, 11% ulcer. Positive diagnoses by UBT were 41% for naive and 17% for post-eradication. Overall ImmunoCard and EIA accuracies were respectively 91% (95%c.i. =88-94%) and 89% (86-93%), sensitivities 72% (67-78%) and 72% (67-78%), and specificities 98% (96-100%), and 95% (92-97%). Concordance between ImmunoCard and EIA was 95% (93-98%).
Discussion: Our results indicate that the newly available ImmunoCard rapid stool antigen-test achieves 90% accuracy, with high specificity but suboptimal sensitivity. The ImmunoCard attained equivalent accuracies as the EIA bench standard, with 95% concordance. (C) 2019 Elsevier Espana, S.L.U. All rights reserved.
Filiaciones:
McNicholl AG:
Gastroenterology Unit, La Princesa University Hospital, Instituto de Investigación Sanitaria Princesa (IIS-IP), Universidad Autónoma de Madrid, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain
Garre A:
Gastroenterology Unit, La Princesa University Hospital, Instituto de Investigación Sanitaria Princesa (IIS-IP), Universidad Autónoma de Madrid, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain
Llorca L:
Microbiology Service, La Princesa University Hospital and Instituto de Investigación Sanitaria Princesa (IIS-IP), Madrid, Spain
Bujanda L:
Digestive Service, Donostia University Hospital and Instituto Biodonostia, Universidad del País Vasco UPV/EHU and CIBERehd, San Sebastián, Spain
Molina-Infante J:
Digestive Service, San Pedro de Alcántara Hospital, and CIBERehd, Cáceres, Spain
Barenys M:
Digestive Service, Viladecans Hospital, Barcelona, Spain
Perez J:
Gastroenterology Unit, La Princesa University Hospital, Instituto de Investigación Sanitaria Princesa (IIS-IP), Universidad Autónoma de Madrid, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain
Guerrero-Torres MD:
Microbiology Service, La Princesa University Hospital and Instituto de Investigación Sanitaria Princesa (IIS-IP), Madrid, Spain
Tamayo E:
Microbiology Service, Donostia University Hospital and Instituto Biodonostia, Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), San Sebastián, Spain
Montes M:
Microbiology Service, Donostia University Hospital and Instituto Biodonostia, Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), San Sebastián, Spain
Prados-Manzano R:
Digestive Service, San Pedro de Alcántara Hospital, and CIBERehd, Cáceres, Spain
Sanchez-Garcia A:
Digestive Service, Hospital Clínic de Barcelona, and CIBERehd, Barcelona, Spain
Ramas M:
Gastroenterology Unit, La Princesa University Hospital, Instituto de Investigación Sanitaria Princesa (IIS-IP), Universidad Autónoma de Madrid, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain
Valdez Blanco VB:
Microbiology Service, La Princesa University Hospital and Instituto de Investigación Sanitaria Princesa (IIS-IP), Madrid, Spain
Montoro M:
Digestive Service, San Jorge Hospital, Huesca, Spain
Calvet X:
Digestive Service, Hospital Universitari Parc Taulí, and CIBERehd, Sabadell, Spain
Figuerola A:
Digestive Service, Hospital Universitari Parc Taulí, and CIBERehd, Sabadell, Spain
Lario S:
Digestive Service, Hospital Universitari Parc Taulí, and CIBERehd, Sabadell, Spain
Quilez E:
Digestive Service, Hospital Universitari Parc Taulí, and CIBERehd, Sabadell, Spain
Lanas A:
Digestive Service, Lozano Blesa Hospital, and CIBERehd, Zaragoza, Spain
:
Digestive Service, Castellón Hospital, Castellón, Spain
Perez-Aisa A:
Digestive Service, Agencia Sanitaria Costa del Sol Hospital, Málaga, Spain
Donday MG:
Gastroenterology Unit, La Princesa University Hospital, Instituto de Investigación Sanitaria Princesa (IIS-IP), Universidad Autónoma de Madrid, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain
Belloc B:
Digestive Service, San Jorge Hospital, Huesca, Spain
Montserrat-Torres A:
Digestive Service, Hospital Universitari Parc Taulí, and CIBERehd, Sabadell, Spain
Fernandez-Moreno N:
Digestive Service, Agencia Sanitaria Costa del Sol Hospital, Málaga, Spain
Ramírez MJ:
Digestive Service, Hospital Universitari Parc Taulí, and CIBERehd, Sabadell, Spain
Alarcon T:
Microbiology Service, La Princesa University Hospital and Instituto de Investigación Sanitaria Princesa (IIS-IP), Madrid, Spain
Gisbert JP:
Gastroenterology Unit, La Princesa University Hospital, Instituto de Investigación Sanitaria Princesa (IIS-IP), Universidad Autónoma de Madrid, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain
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