Accuracy of Monoclonal Stool Tests for Determining Cure of Helicobacter pylori Infection After Treatment |
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| Authors: | Xavier Calvet Sergio Lario María José Ramírez‐Lázaro Antònia Montserrat Mariela Quesada Lynsey Reeves Helen Masters David Suárez‐Lamas Marta Gallach Mireia Miquel Eva Martínez‐Bauer Isabel Sanfeliu Ferran Segura |
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| Affiliation: | 1. Servei de Digestiu, Hospital de Sabadell, Institut Universitari Parc Taulí, Departament de Medicina, Universitat Autònoma de Barcelona;2. Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Instituto de Salud Carlos III;3. Oxoid Ltd, Cambridge, UK;4. Unitat d’Epidemiologia I Suport a la Recerca, Fundació Parc Taulí;5. Laboratori de Microbiologia‐UDIAT‐CD, Hospital de Sabadell, Institut Universitari Parc Taulí, Departament de Medicina, Universitat Autònoma de Barcelona;6. Spanish Network for Research in Infectious Diseases (REIPI RD06/0018), Sabadell, Barcelona, Spain;7. Servei de Malalties Infeccioses, Hospital de Sabadell, Institut Universitari Parc Taulí, Departament de Medicina, Universitat Autònoma de Barcelona, Barcelona, Spain |
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| Abstract: | Background: Studies comparing new monoclonal fecal tests for evaluating cure of Helicobacter pylori infection after treatment are scarce. The objective was to compare the diagnostic accuracy of three monoclonal stool tests: two rapid in‐office tools –RAPID Hp StAR and ImmunoCard STAT! HpSA – and an EIA test – Amplified IDEIA Hp StAR. Materials and methods: Diagnostic reliability of the three tests was evaluated in 88 patients at least 8 weeks after H. pylori treatment. Readings of immunochromatographic tests were performed by two different observers. Sensitivity, specificity, positive and negative predictive values and 95% confidence intervals were calculated. Results: All tests presented similar performance for post‐eradication testing. Sensitivity for detecting persistent infection was 100% for both Amplified IDEIA and RAPID Hp StAR and 90% for ImmunoCard STAT! HpSA. Respective specificities were 94.9%, 92.3–93.6% and 94.9%. Negative predictive values were very high (100%, 100% and 98.7% respectively). But positive predictive values were lower, ranging from 62.5 to 71.4%. Conclusion: All monoclonal fecal tests in this series presented similar performance in the post‐treatment setting. A negative test after treatment adequately predicted cure of the infection. However, nearly a third of tests were false positive, showing a poor predictive yield for persistent infection. |
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| Keywords: | Helicobacter pylori immunoassay post‐eradication follow‐up sensitivity and specificity |
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