Evaluation of a New Monoclonal Chemiluminescent Immunoassay Stool Antigen Test for the Diagnosis of Helicobacter pylori Infection: A Spanish Multicentre Study

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...

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Autores: 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.
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2022
País:España
Institución:Universidad de Barcelona
Repositorio:Dipòsit Digital de la UB
OAI Identifier:oai:diposit.ub.edu:2445/189565
Acceso en línea:https://hdl.handle.net/2445/189565
Access Level:acceso abierto
Palabra clave:Helicobacter pylori
Diagnòstic
Diagnosis
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spelling Evaluation of a New Monoclonal Chemiluminescent Immunoassay Stool Antigen Test for the Diagnosis of Helicobacter pylori Infection: A Spanish Multicentre StudyResina, ElenaDonday, María G.Martínez Domínguez, Samuel J.Laserna Mendieta, Emilio JoséLanas, ÁngelLucendo, Alfredo J.Sánchez Luengo, MartaAlcaide, NoeliaFernández Salazar, LuisDe La Peña Negro, LuisaBujanda, LuisArbulo, Marta Gómez Ruiz DeAlcedo, JavierPérez Aisa, ÁngelesRodríguez, RaúlHermida, SandraBrenes, YanireNyssen, Olga P.Gisbert, Javier P.Helicobacter pyloriDiagnòsticHelicobacter pyloriDiagnosisThe 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.MDPI AG2022info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://hdl.handle.net/2445/189565Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))reponame:Dipòsit Digital de la UBinstname:Universidad de BarcelonaInglésReproducció del document publicat a: https://doi.org/10.3390/jcm11175077Journal of Clinical Medicine, 2022, vol. 11, num. 17, p. 5077https://doi.org/10.3390/jcm11175077cc by (c) Resina, Elena et al., 2022http://creativecommons.org/licenses/by/3.0/es/info:eu-repo/semantics/openAccessoai:diposit.ub.edu:2445/1895652026-05-27T06:46:51Z
dc.title.none.fl_str_mv Evaluation of a New Monoclonal Chemiluminescent Immunoassay Stool Antigen Test for the Diagnosis of Helicobacter pylori Infection: A Spanish Multicentre Study
title Evaluation of a New Monoclonal Chemiluminescent Immunoassay Stool Antigen Test for the Diagnosis of Helicobacter pylori Infection: A Spanish Multicentre Study
spellingShingle Evaluation of a New Monoclonal Chemiluminescent Immunoassay Stool Antigen Test for the Diagnosis of Helicobacter pylori Infection: A Spanish Multicentre Study
Resina, Elena
Helicobacter pylori
Diagnòstic
Helicobacter pylori
Diagnosis
title_short Evaluation of a New Monoclonal Chemiluminescent Immunoassay Stool Antigen Test for the Diagnosis of Helicobacter pylori Infection: A Spanish Multicentre Study
title_full Evaluation of a New Monoclonal Chemiluminescent Immunoassay Stool Antigen Test for the Diagnosis of Helicobacter pylori Infection: A Spanish Multicentre Study
title_fullStr Evaluation of a New Monoclonal Chemiluminescent Immunoassay Stool Antigen Test for the Diagnosis of Helicobacter pylori Infection: A Spanish Multicentre Study
title_full_unstemmed Evaluation of a New Monoclonal Chemiluminescent Immunoassay Stool Antigen Test for the Diagnosis of Helicobacter pylori Infection: A Spanish Multicentre Study
title_sort Evaluation of a New Monoclonal Chemiluminescent Immunoassay Stool Antigen Test for the Diagnosis of Helicobacter pylori Infection: A Spanish Multicentre Study
dc.creator.none.fl_str_mv 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.
author Resina, Elena
author_facet 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.
author_role author
author2 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.
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Helicobacter pylori
Diagnòstic
Helicobacter pylori
Diagnosis
topic Helicobacter pylori
Diagnòstic
Helicobacter pylori
Diagnosis
description 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.
publishDate 2022
dc.date.none.fl_str_mv 2022
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/2445/189565
url https://hdl.handle.net/2445/189565
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv 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
dc.rights.none.fl_str_mv cc by (c) Resina, Elena et al., 2022
http://creativecommons.org/licenses/by/3.0/es/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv cc by (c) Resina, Elena et al., 2022
http://creativecommons.org/licenses/by/3.0/es/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv MDPI AG
publisher.none.fl_str_mv MDPI AG
dc.source.none.fl_str_mv Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))
reponame:Dipòsit Digital de la UB
instname:Universidad de Barcelona
instname_str Universidad de Barcelona
reponame_str Dipòsit Digital de la UB
collection Dipòsit Digital de la UB
repository.name.fl_str_mv
repository.mail.fl_str_mv
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