Clinical Performance of the Automated LIAISON® Meridian H. pylori SA Stool Antigen Test.
Biomed Res Int
; 2020: 7189519, 2020.
Article
em En
| MEDLINE
| ID: mdl-32280698
ABSTRACT
BACKGROUND:
Antigens derived from Helicobacter pylori can be used as stool biomarkers to assist in the diagnosis of H. pylori infection. Since current assays have variable performance, we assessed the clinical performance of the automated LIAISON® Meridian H. pylori infection. Since current assays have variable performance, we assessed the clinical performance of the automated LIAISON® Meridian.METHODS:
This prospective multisite study enrolled patients undergoing an esophagogastroduodenoscopy with collection of biopsy and stool specimens. Adult patients (≥22 years) participated in the study from February 2017 to August 2018. Specimens of the stomach were tested by three methods, known as the Composite ReferenceMethod:
(1) histological evaluation, (2) culture of the organism, and (3) rapid urease detection test. H. pylori infection. Since current assays have variable performance, we assessed the clinical performance of the automated LIAISON® Meridian H. pylori infection. Since current assays have variable performance, we assessed the clinical performance of the automated LIAISON® Meridian.RESULTS:
277 patients (63% female) were included in the study. The prevalence of infected subjects was 24.2% in this study cohort. Clinical performance assessed against the Composite Reference Method showed very good agreement (Cohen's kappa = 0.922), with good sensitivity (95.5%) and specificity (97.6%). Reproducibility study results showed total imprecision ranging from 3.1% to 13.9% CV.CONCLUSION:
The automated LIAISON® Meridian H. pylori SA assay brings reliable noninvasive testing for H. pylori to the laboratory that is in very good agreement with the current, more invasive biopsy-based methods such as histology, culture, or rapid urease test. The clinical trial identifiers are NCT03060746 (pretherapy) and NCT03060733 (posttherapy).H. pylori infection. Since current assays have variable performance, we assessed the clinical performance of the automated LIAISON® Meridian H. pylori infection. Since current assays have variable performance, we assessed the clinical performance of the automated LIAISON® Meridian.
Texto completo:
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Base de dados:
MEDLINE
Assunto principal:
Helicobacter pylori
/
Infecções por Helicobacter
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Técnicas Imunoenzimáticas
/
Fezes
/
Antígenos de Bactérias
Tipo de estudo:
Diagnostic_studies
/
Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Limite:
Adult
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Aged
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Female
/
Humans
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Male
/
Middle aged
Idioma:
En
Revista:
Biomed Res Int
Ano de publicação:
2020
Tipo de documento:
Article
País de afiliação:
Estados Unidos