학술논문
Evaluation of a New Monoclonal Chemiluminescent Immunoassay Stool Antigen Test for the Diagnosis of Helicobacter pylori Infection: A Spanish Multicentre Study.
Document Type
Article
Author
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.; Gisbert, Javier P.
Source
Subject
*ANTIGEN analysis
*RECEIVER operating characteristic curves
*MONOCLONAL gammopathies
*HELICOBACTER pylori
*IMMUNOASSAY
*HELICOBACTER pylori infections
*BREATH tests
*
*
*
*
*
*
Language
ISSN
2077-0383
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. [ABSTRACT FROM AUTHOR]