Dataset Information

Clinical Performance of the Automated LIAISON® Meridian H. pylori SA Stool Antigen Test.

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 Reference Method: (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.

SUBMITTER: Opekun AR

PROVIDER: S-EPMC7114771 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Clinical Performance of the Automated LIAISON® Meridian <i>H. pylori</i> SA Stool Antigen Test.

Opekun Antone R AR Zierold Claudia C Rode Ashli A Blocki Frank A FA Fiorini Giulia G Saracino Ilaria Maria IM Vaira Dino D Sutton Fred M FM

BioMed research international 20200319

<h4>Background</h4>Antigens derived from <i>Helicobacter pylori</i> can be used as stool biomarkers to assist in the diagnosis of <i>H. pylori</i> infection. Since current assays have variable performance, we assessed the clinical performance of the automated LIAISON® Meridian <i>H. pylori</i> infection. Since current assays have variable performance, we assessed the clinical performance of the automated LIAISON® Meridian.<h4>Methods</h4>This prospective multisite study enrolled patients undergo ...[more]

PMID: 32280698

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Project description:ObjectiveHighly sensitive guaiac-based faecal occult blood (Hemoccult SENSA) and Helicobacter pylori stool antigen testing might help detect upper gastrointestinal lesions when appended to a colorectal cancer screening programme with faecal immunochemical testing. We evaluated the diagnostic accuracies of two stool tests in detecting upper gastrointestinal lesions.DesignCross-sectional design.SettingHospital-based and community-based screening settings.ParticipantsA hospital-based deviation cohort of 3172 participants to evaluate test performance and a community-based validation cohort of 3621 to verify the findings.InterventionsThree types of stool tests with bidirectional endoscopy as the reference standard.OutcomesSensitivity, specificity and positive and negative likelihood ratios.ResultsFor detecting upper gastrointestinal lesions in cases with negative immunochemical tests, the sensitivity, specificity, and positive and negative likelihood ratios of the guaiac-based and H pylori antigen tests were 16.3% (95% CI 13.3% to 19.8%), 90.1% (88.9% to 91.2%), 1.64 (1.31 to 2.07), and 0.93 (0.89 to 0.97), respectively, and 52.5% (48.1% to 56.9%), 80.6% (79.0% to 82.1%), 2.71 (2.41 to 3.04) and 0.59 (0.54 to 0.65), respectively. For detecting upper gastrointestinal lesions in cases with normal colonoscopy, the results of the guaiac-based and H pylori antigen tests were 17.9% (14.8% to 21.5%), 90.1% (88.9% to 91.2%), 1.81 (1.45 to 2.26) and 0.91 (0.87 to 0.95), respectively, and 53.1% (48.6% to 57.4%), 80.7% (79.1% to 82.2%), 2.75 (2.45 to 3.08) and 0.58 (0.53 to 0.64), respectively. Within the community, positive predictive values of the immunochemical and H pylori antigen tests were 36.0% (26.0% to 46.0%) and 31.9% (28.3% to 35.5%), respectively, for detecting lower and upper gastrointestinal lesions, which were similar to expected values.ConclusionsThe H pylori stool antigen test is more accurate than the guaiac-based test in the screening of upper gastrointestinal lesions in a population with high prevalence of H pylori infection and upper gastrointestinal lesions. It is applicable to add the H pylori antigen test to the immunochemical test for pan detection.Trial registrationNCT01341197 (ClinicalTrial.gov).

Project description:Helicobacter pylori (H. pylori) can cause gastritis, peptic ulcer diseases and gastric carcinoma. Endoscopy as the gold standard method of diagnosis is an invasive procedure that might not be suitable in all scenarios. Therefore, this first study in Jordan aimed to assess the non-invasive 13C urea breath test (UBT) and stool antigen test for diagnosis of H. pylori infection and the successfulness of eradication therapy as alternatives for endoscopy. Hence, a total of 30 patients attending the endoscopy units at Alkarak teaching hospital were asked to complete a questionnaire with demographic and clinical data. They were then tested for H. pylori using 13C UBT and H. pylori stool antigen before having endoscopy. Another 30 patients who were positive for H. pylori by endoscopy were tested using both tests 6 weeks post eradication therapy. Results showed that the rate of H. pylori detection using endoscopy was 56.7% (17/30). Heartburns (82.3%, p value = 0.019), epigastric pain (88.2%, p value = 0.007) and vomiting (70.5%, p value = 0.02) were the most significant symptoms. Family history of peptic ulcer diseases was significantly associated with an increased risk for having a H. pylori positive result (p value = 0.02). Compared to endoscopy, the sensitivity of 13C UBT for the diagnosis of H. pylori was 94.1% (16/17), while it was 76.5% (13/17) for the stool antigen test. The specificity of both tests was equal (76.9%). However, the positive predictive and negative predictive values (84.2% and 90.9%) for 13C UBT were higher than those (81.3% and 71.4%) for the stool antigen test. The accuracy of 13C UBT was 86.7% compared to 76.7% for the stool antigen test. There was an 87% agreement (20 patients out of 23) between both tests when used to assess success of the eradication therapy. In conclusion, the 13C UBT was found to be more sensitive and accurate than the stool antigen test when used for diagnosis; furthermore, it has a comparable outcome to the stool antigen test in assessing the successfulness of the eradication treatment.

Dataset Information

Clinical Performance of the Automated LIAISON® Meridian H. pylori SA Stool Antigen Test.

Publications

Clinical Performance of the Automated LIAISON® Meridian <i>H. pylori</i> SA Stool Antigen Test.

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