Academic Journal
Performance and reproducibility of Pylori DuoTect® in a high Helicobacter pylori prevalence Latin American population.
| Τίτλος: | Performance and reproducibility of Pylori DuoTect® in a high Helicobacter pylori prevalence Latin American population. |
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| Συγγραφείς: | Laszkowska M; Gastroenterology, Hepatology, and Nutrition Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA., Warnakulasuriya K; Center for Personalized Diagnostics, Biodesign Institute, Arizona State University, Tempe, AZ, USA., Trendler T; Center for Personalized Diagnostics, Biodesign Institute, Arizona State University, Tempe, AZ, USA., Corvalan AH; Department of Hematology/Oncology and Advanced Center for Chronic Diseases (ACCDiS), Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile., Malfertheiner P; Medical Department II, University Hospital, Ludwig-Maximilians-Universität, Munich, Germany., Kalali B; ImevaX GmbH, Munich, Germany., Abnet CC; Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Rockville, MD, USA., Qiu J; Center for Personalized Diagnostics, Biodesign Institute, Arizona State University, Tempe, AZ, USA., Castle PE; Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Rockville, MD, USA; Division of Cancer Prevention, National Cancer Institute, Bethesda, MD, USA., Camargo MC; Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Rockville, MD, USA. Electronic address: camargomc@mail.nih.gov. |
| Πηγή: | Journal of microbiology, immunology, and infection = Wei mian yu gan ran za zhi [J Microbiol Immunol Infect] 2026 Oct; Vol. 59 (5), pp. 589-593. Date of Electronic Publication: 2026 May 18. |
| Τύπος έκδοσης: | Journal Article |
| Γλώσσα: | English |
| Στοιχεία περιοδικού: | Publisher: published by Elsevier for the Taiwan Society of Microbiology Country of Publication: England NLM ID: 100956211 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1995-9133 (Electronic) Linking ISSN: 16841182 NLM ISO Abbreviation: J Microbiol Immunol Infect Subsets: MEDLINE |
| Imprint Name(s): | Publication: Feb. 2010- : Oxford, England : published by Elsevier for the Taiwan Society of Microbiology Original Publication: Taipei, Taiwan : Chinese Society of Microbiology : Chinese Society of Immunology [and] : Infectious Diseases Society of the Republic of China |
| Ιατρικοί όροι (MeSH): | Helicobacter Infections*/diagnosis , Helicobacter Infections*/epidemiology , Helicobacter Infections*/microbiology , Helicobacter pylori*/immunology , Helicobacter pylori*/isolation & purification, Antigens, Bacterial/immunology ; Antigens, Bacterial/blood ; Antibodies, Bacterial/blood ; Bacterial Proteins/immunology ; Chile/epidemiology ; Humans ; Sensitivity and Specificity ; Female ; Middle Aged ; Adult ; Male ; Reproducibility of Results ; Prevalence ; Enzyme-Linked Immunosorbent Assay ; Aged ; Urease ; Stomach Neoplasms ; Rapid Diagnostic Tests |
| Περίληψη: | Background: An accurate, rapid, non-invasive test is critically needed for Helicobacter pylori infection, particularly in under-resourced populations at increased risk of gastric cancer. Aims: This study compared the performance of Pylori DuoTect® to a spectrum of other tests. Methods: Serum samples collected from Chilean adults with gastrointestinal symptoms who had undergone esophagogastroduodenoscopy were tested with the Pylori DuoTect® test for anti-FliD (flagellar hook-associated protein) and anti-CagA (cytotoxin-associated antigen gene A) antibodies, and compared to testing by urease, histology, whole-cell ELISA, CagA ELISA, and H. pylori-NAPPA array. We calculated sensitivity, specificity, and agreement based on Cohen's kappa statistic of the Pylori DuoTect® test to other tests. Results: Based on histology or rapid urease testing, 156 of 300 individuals (52%) were positive for H. pylori. Based on the Pylori DuoTect® test, 70 (45%) were seropositive for FliD, 94 (60%) for CagA, 127 (81%) for either FliD or CagA, and 37 (24%) for both. Sensitivity of either FliD or CagA detection for a positive H. pylori test by histology or urease testing was 81.1% and specificity was 29.2%. The Pylori DuoTect® test had the highest level of agreement with the CagA NAPPA and ELISA tests (81.3-82.0%). Conclusions: The Pylori DuoTect® test showed high sensitivity but low specificity for H. pylori detection compared to histology or urease testing. However, it aligned well with performance of CagA detection. While this assay may hold promise based on ease of use, it requires additional optimization and validation to better define the performance characteristics across diverse, global populations. (Copyright © 2026. Published by Elsevier B.V.) |
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| Grant Information: | K08 DK125876 United States DK NIDDK NIH HHS; P30 CA008748 United States CA NCI NIH HHS; U01 CA265729 United States CA NCI NIH HHS; Z99 CA999999 United States ImNIH Intramural NIH HHS |
| Contributed Indexing: | Keywords: CagA; Gastric cancer; Helicobacter pylori; Point of care testing |
| Substance Nomenclature: | 0 (Antigens, Bacterial) 0 (Antibodies, Bacterial) 0 (Bacterial Proteins) 0 (cagA protein, Helicobacter pylori) EC 3.5.1.5 (Urease) |
| Entry Date(s): | Date Created: 20260523 Date Completed: 20260918 Latest Revision: 20261022 |
| Update Code: | 20261022 |
| PubMed Central ID: | PMC13679993 |
| DOI: | 10.1016/j.jmii.2026.05.004 |
| PMID: | 42177123 |
| Βάση Δεδομένων: | MEDLINE |
| ISSN: | 1995-9133 |
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| DOI: | 10.1016/j.jmii.2026.05.004 |