Prospective,study comparing the accuracy of two different stool antigen tests (Premier Platinum HpSA and novel ImmunoCard STAT! rapid test) for the diagnosis of Helicobacter pylori infection |
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| Institution: | 1. 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;2. Microbiology Service, La Princesa University Hospital and Instituto de Investigación Sanitaria Princesa (IIS-IP), Madrid, Spain;3. Digestive Service, Donostia University Hospital and Instituto Biodonostia, Universidad del País Vasco UPV/EHU and CIBERehd, San Sebastián, Spain;4. Digestive Service, San Pedro de Alcántara Hospital, and CIBERehd, Cáceres, Spain;5. Digestive Service, Viladecans Hospital, Barcelona, Spain;6. Microbiology Service, Donostia University Hospital and Instituto Biodonostia, Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), San Sebastián, Spain;7. Digestive Service, Hospital Clínic de Barcelona, and CIBERehd, Barcelona, Spain;8. Digestive Service, San Jorge Hospital, Huesca, Spain;9. Digestive Service, Hospital Universitari Parc Taulí, and CIBERehd, Sabadell, Spain;10. Digestive Service, Lozano Blesa Hospital, and CIBERehd, Zaragoza, Spain;11. Digestive Service, Castellón Hospital, Castellón, Spain;12. Digestive Service, Agencia Sanitaria Costa del Sol Hospital, Málaga, Spain;1. Department of Hepatobiliary Surgery II, State Key Laboratory of Organ Failure Research, Guangdong Provincial Research Center for Artificial Organ and Tissue Engineering, Guangzhou Clinical Research and Transformation Center for Artificial Liver, Institute of Regenerative Medicine, Zhujiang Hospital, Southern Medical University, Guangzhou 510280, Guangdong Province, China;2. General Surgery Department, The Second Hospital of Shenzhen Baoan People''s Hospital Group, Shenzhen 518108, Guangdong Province, China;1. Department of Gastroenterology, West China Hospital, Sichuan University, Chengdu, Sichuan, China;2. Department of Radiology, West China Hospital, Sichuan University, Chengdu, Sichuan, China;3. Department of Gastroenterology, Sichuan Provincial Disabled Revolutionary Armyman Hospital, Chengdu, China;1. Servicio de Dermatología, Hospital Costa del Sol, Marbella, Málaga, España;2. Servicio de Anatomía Patológica, Hospital Costa del Sol, Marbella, Málaga, España;1. Department of Digestive Diseases, Miguel Servet University Hospital, Zaragoza, Spain;2. Aragón Health Research Institute (IIS Aragón), Spain |
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| Abstract: | BackgroundAt 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 STAT! HpSA HD (rapid test) for the initial diagnosis and the confirmation of eradication of H. pylori infection.Patients and methodsPatients 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 (13C-urea breath test, UBT). The EIA was used as a bench standard. All stool tests were performed in duplicate.Results264 patients completed the protocol (100 naïve, 164 post-eradication). Average age was 52 years, 61% women, 11% ulcer. Positive diagnoses by UBT were 41% for naïve 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%).DiscussionOur 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. |
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| Keywords: | Antigen Diagnosis Stool feces Antígeno Diagnóstico Heces |
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