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

Authors :
Elena Resina
María G. Donday
Samuel J. Martínez-Domínguez
Emilio José Laserna-Mendieta
Ángel Lanas
Alfredo J. Lucendo
Marta Sánchez-Luengo
Noelia Alcaide
Luis Fernández-Salazar
Luisa De La Peña-Negro
Luis Bujanda
Marta Gómez-Ruiz de Arbulo
Javier Alcedo
Ángeles Pérez-Aísa
Raúl Rodríguez
Sandra Hermida
Yanire Brenes
Olga P. Nyssen
Javier P. Gisbert
Source :
Journal of Clinical Medicine; Volume 11; Issue 17; Pages: 5077, Dipòsit Digital de la UB, Universidad de Barcelona
Publication Year :
2022
Publisher :
MDPI AG, 2022.

Abstract

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.

Details

Language :
English
Database :
OpenAIRE
Journal :
Journal of Clinical Medicine; Volume 11; Issue 17; Pages: 5077, Dipòsit Digital de la UB, Universidad de Barcelona
Accession number :
edsair.doi.dedup.....f5804784282a0ff5b8ad38df7f8f0b56