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® Meridian H. pylori SA based on monoclonal antibodies, compared to the defined gold standard 13C-urea breath te...

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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-Aísa, Ángeles, Rodríguez, Raúl, Hermida, Sandra, Brenes, Yanire, Nyssen, Olga P., Pérez Gisbert, Francisco Javier
Tipo de recurso: artículo
Fecha de publicación:2022
País:España
Institución:Universidad Autónoma de Madrid
Repositorio:Biblos-e Archivo. Repositorio Institucional de la UAM
Idioma:inglés
OAI Identifier:oai:repositorio.uam.es:10486/714653
Acceso en línea:http://hdl.handle.net/10486/714653
https://dx.doi.org/10.3390/jcm11175077
Access Level:acceso abierto
Palabra clave:diagnosis
Helicobacter pylori
stool antigen test
urea breath test
Medicina
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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-Aísa, ÁngelesRodríguez, RaúlHermida, SandraBrenes, YanireNyssen, Olga P.Pérez Gisbert, Francisco JavierdiagnosisHelicobacter pyloristool antigen testurea breath testMedicinaThe 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® Meridian H. pylori SA based on monoclonal antibodies, compared to the defined gold standard 13C-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 naïve, 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® Meridian H. pylori SA SAT showed a good accuracy for diagnosis of H. pylori infectionMDPIDepartamento de MedicinaFacultad de Medicina20222022-09-01research articlehttp://purl.org/coar/resource_type/c_2df8fbb1VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/10486/714653https://dx.doi.org/10.3390/jcm11175077reponame:Biblos-e Archivo. Repositorio Institucional de la UAMinstname:Universidad Autónoma de MadridInglésengopen accesshttp://purl.org/coar/access_right/c_abf2Attribution 4.0 Internationalhttp://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:repositorio.uam.es:10486/7146532026-06-23T12:46:27Z
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
diagnosis
Helicobacter pylori
stool antigen test
urea breath test
Medicina
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-Aísa, Ángeles
Rodríguez, Raúl
Hermida, Sandra
Brenes, Yanire
Nyssen, Olga P.
Pérez Gisbert, Francisco Javier
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-Aísa, Ángeles
Rodríguez, Raúl
Hermida, Sandra
Brenes, Yanire
Nyssen, Olga P.
Pérez Gisbert, Francisco Javier
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-Aísa, Ángeles
Rodríguez, Raúl
Hermida, Sandra
Brenes, Yanire
Nyssen, Olga P.
Pérez Gisbert, Francisco Javier
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Departamento de Medicina
Facultad de Medicina
dc.subject.none.fl_str_mv diagnosis
Helicobacter pylori
stool antigen test
urea breath test
Medicina
topic diagnosis
Helicobacter pylori
stool antigen test
urea breath test
Medicina
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® Meridian H. pylori SA based on monoclonal antibodies, compared to the defined gold standard 13C-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 naïve, 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® Meridian H. pylori SA SAT showed a good accuracy for diagnosis of H. pylori infection
publishDate 2022
dc.date.none.fl_str_mv 2022
2022-09-01
dc.type.none.fl_str_mv research article
http://purl.org/coar/resource_type/c_2df8fbb1
VoR
http://purl.org/coar/version/c_970fb48d4fbd8a85
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv http://hdl.handle.net/10486/714653
https://dx.doi.org/10.3390/jcm11175077
url http://hdl.handle.net/10486/714653
https://dx.doi.org/10.3390/jcm11175077
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv MDPI
publisher.none.fl_str_mv MDPI
dc.source.none.fl_str_mv reponame:Biblos-e Archivo. Repositorio Institucional de la UAM
instname:Universidad Autónoma de Madrid
instname_str Universidad Autónoma de Madrid
reponame_str Biblos-e Archivo. Repositorio Institucional de la UAM
collection Biblos-e Archivo. Repositorio Institucional de la UAM
repository.name.fl_str_mv
repository.mail.fl_str_mv
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