2026-04-17T06:31:06Zhttps://recercat.cat/oai/request

oai:recercat.cat:2445/1895652025-12-05T12:26:33Zcom_2072_1057col_2072_478916col_2072_478917

urn:hdl:2445/189565 Evaluation of a New Monoclonal Chemiluminescent Immunoassay Stool Antigen Test for the Diagnosis of Helicobacter pylori Infection: A Spanish Multicentre Study Resina, Elena Donday, María G. Martínez Domínguez, Samuel J. Laserna Mendieta, Emilio José Lanas, Ángel Lucendo, Alfredo J. Sánchez Luengo, Marta Alcaide, Noelia Fernández Salazar, Luis De La Peña Negro, Luisa Bujanda, Luis Arbulo, Marta Gómez Ruiz De Alcedo, Javier Pérez Aisa, Ángeles Rodríguez, Raúl Hermida, Sandra Brenes, Yanire Nyssen, Olga P. Gisbert, Javier P. Helicobacter pylori Diagnòstic Helicobacter pylori Diagnosis The stool antigen test (SAT) represents an attractive alternative for detection of Helicobacter pylori. The aim of this study was to assess the accuracy of a new SAT, the automated LIAISON(R) Meridian H. pylori SA based on monoclonal antibodies, compared to the defined gold standard C-13-urea breath test (UBT). This prospective multicentre study (nine Spanish centres) enrolled patients >= 18 years of age with clinical indication to perform UBT for the initial diagnosis and for confirmation of bacterial eradication. Two UBT methods were used: mass spectrometry (MS) including citric acid (CA) or infrared spectrophotometry (IRS) without CA. Overall, 307 patients (145 naive, 162 with confirmation of eradication) were analysed. Using recommended cut-off values (negative SAT < 0.90, positive >= 1.10) the sensitivity, specificity, positive predictive value, negative predictive value and accuracy were 67%, 97%, 86%, 92% and 91%, respectively, obtaining an area under the receiver operating characteristic (ROC) curve (AUC) of 0.85. Twenty-eight patients, including seven false positives and 21 false negatives, presented a discordant result between SAT and UBT. Among the 21 false negatives, four of six tested with MS and 11 of 15 tested with IRS presented a borderline UBT delta value. In 25 discordant samples, PCR targeting H. pylori DNA was performed to re-assess positivity and SAT accuracy was re-analysed: sensitivity, specificity, positive predictive value, negative predictive value, accuracy and AUC were 94%, 97%, 86%, 99%, 97% and 0.96, respectively. The new LIAISON(R) Meridian H. pylori SA SAT showed a good accuracy for diagnosis of H. pylori infection. 2022-10-03T09:57:37Z 2022-10-03T09:57:37Z 2022-08-29 2022-09-29T10:22:47Z info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Reproducció del document publicat a: https://doi.org/10.3390/jcm11175077 Journal of Clinical Medicine, 2022, vol. 11, num. 17, p. 5077 https://doi.org/10.3390/jcm11175077 cc by (c) Resina, Elena et al., 2022 http://creativecommons.org/licenses/by/3.0/es/ info:eu-repo/semantics/openAccess MDPI AG Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))