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. 2022 Aug 29;11(17):5077.
doi: 10.3390/jcm11175077.

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

Elena Resina  1 , María G Donday  1 , Samuel J Martínez-Domínguez  2 , Emilio José Laserna-Mendieta  3   4   5   6 , Ángel Lanas  2 , Alfredo J Lucendo  4   5   6   7 , Marta Sánchez-Luengo  2 , Noelia Alcaide  8 , Luis Fernández-Salazar  8 , Luisa De La Peña-Negro  9 , Luis Bujanda  10 , Marta Gómez-Ruiz de Arbulo  11 , Javier Alcedo  12 , Ángeles Pérez-Aísa  13 , Raúl Rodríguez  14 , Sandra Hermida  1 , Yanire Brenes  1 , Olga P Nyssen  1 , Javier P Gisbert  1
Affiliations

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

Elena Resina et al. J Clin Med. .

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.

Keywords: Helicobacter pylori; diagnosis; stool antigen test; urea breath test.

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Conflict of interest statement

Javier P. Gisbert served as a speaker, a consultant and advisory member for or has received research funding from Mayoly, Allergan, Diasorin, Gebro Pharma, and Richen. Olga P. Nyssen received research funding from Allergan and Mayoly Spindler. Luis Bujanda served as consultant or has received research funding from Ikan Biotech. Javier Alcedo served as a speaker, an advisory member for, or has received research funding from Allergan and Isomed Pharma. The remaining authors have no potential conflict of interest. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, or in the decision to publish the results.

Figures

Figure 1
Figure 1
Flow diagram of the enrolled patients.
Figure 2
Figure 2
Standards for the Reporting of Diagnostic Accuracy Studies (STARD) flow diagram of the study. N: number of patients included; SAT: stool antigen test; GS+: gold standard positive; GS−: gold standard negative.
See this image and copyright information in PMC

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