Clinical Performance of the Automated LIAISON® Meridian H. pylori SA Stool Antigen Test.
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 SA chemiluminescent immunoassay a...
| Publicado en: | BioMed Research International pp. 1 - 7 |
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| Autores principales: | , , , , , , , |
| Formato: | research tables/charts Journal Article |
| Publicado: |
Wiley-Blackwell
3/21/2020
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=142387503&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 142387503 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 23146133 FT2T jtl: BioMed Research International issn: 23146133 maglogo: N pubinfo: dt: 3/21/2020 pid: 480 pub: Wiley-Blackwell place: Malden, Massachusetts artinfo: ui: 142387503 142387503 142387503 10.1155/2020/7189519 142387503 ppf: 1 ppct: 6 formats: fmt: – @attributes: type: T – @attributes: type: P tig: atl: Clinical Performance of the Automated LIAISON® Meridian H. pylori SA Stool Antigen Test. aug: au: Opekun, Antone R. Zierold, Claudia Rode, Ashli Blocki, Frank A. Fiorini, Giulia Saracino, Ilaria Maria Vaira, Dino Sutton, Fred M. affil: Division of Gastroenterology and Hepatology, Department of Internal Medicine, Baylor College of Medicine, Houston, TX 77030, USA sug: subj: Helicobacter Infections Diagnosis Feces Analysis Antigens, Bacterial Analysis Bacteriological Techniques Biological Markers Predictive Value of Tests Evaluation Human Male Female Prospective Studies Multicenter Studies Endoscopy, Digestive System Biopsy Immunoassay Data Analysis Software kappa Statistic Sensitivity and Specificity Reproducibility of Results Reliability Male Female ab: 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 SA chemiluminescent immunoassay against more invasive biopsy tests that are considered to be the "gold standard" (Composite Reference Method). 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 Reference Method: (1) histological evaluation, (2) culture of the organism, and (3) rapid urease detection test. H. pylori in stool was detected using the automated LIAISON® Meridian H. pylori SA assay, a chemiluminescent immunoassay. Statistical analyses were performed using MedCalc 18.11.6. 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 (Cohe n ' 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). pubtype: Academic Journal doctype: research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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