Prospective, study comparing the accuracy of two different stool antigen tests (Premier Platinum HpSA and novel ImmunoCard STAT! rapid test) for the diagnosis of Helicobacter pylori infection

McNicholl, Adrián G.; Garre, Ana; Llorca, Laura; Bujanda, Luís; Molina–Infante, Javier; Barenys, Mercè; Perez, Julia; Guerrero-Torres, María Dolores; Tamayo, Esther; Montes, Milagrosa; Prados-Manzano, Raul; Rivero-Sánchez, L; Ramas, Mercedes; Blanco, Veronica B. Valdez; Montoro, Miguel; Calvet, Xavier; Figuerola, Ariadna; Lario, Sergio; Quilez, Eia; Lanas, Fernando; Silva-Pomarino, Pia; Pérez-Aísa, Ángeles; Donday, María G.; Belloc, Blanca; Montserrat-Torres, Antonia; Fernández-Moreno, N; Ramı́rez, Marı́a José; Alarcón, Teresa; Gisbert, Javier P.

doi:10.1016/j.gastrohep.2019.09.009

Cited by 7 publications

(4 citation statements)

References 19 publications

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“…Available SATs for H. pylori include both enzyme immuno assay (EIA) test kits for use in laboratories, as well as rapid immunochromatography tests for near patient testing by the gastroenterologist or general practitioner 102 105. In most comparative studies, laboratory-based EIA tests performed better than rapid tests,103 106 107 but the best rapid tests do have acceptable performance for clinical diagnostic use 108 109. Results vary substantially between the different available rapid tests.…”

Section: Wg 2: Diagnosticsmentioning

confidence: 99%

Management ofHelicobacter pyloriinfection: the Maastricht VI/Florence consensus report

Malfertheiner

Mégraud

Rokkas

et al. 2022

Gut

603

842

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Helicobacter pyloriInfection is formally recognised as an infectious disease, an entity that is now included in the International Classification of Diseases 11th Revision. This in principle leads to the recommendation that all infected patients should receive treatment. In the context of the wide clinical spectrum associated with Helicobacter pylori gastritis, specific issues persist and require regular updates for optimised management.The identification of distinct clinical scenarios, proper testing and adoption of effective strategies for prevention of gastric cancer and other complications are addressed. H. pylori treatment is challenged by the continuously rising antibiotic resistance and demands for susceptibility testing with consideration of novel molecular technologies and careful selection of first line and rescue therapies. The role of H. pylori and antibiotic therapies and their impact on the gut microbiota are also considered.Progress made in the management of H. pylori infection is covered in the present sixth edition of the Maastricht/Florence 2021 Consensus Report, key aspects related to the clinical role of H. pylori infection were re-evaluated and updated. Forty-one experts from 29 countries representing a global community, examined the new data related to H. pylori infection in five working groups: (1) indications/associations, (2) diagnosis, (3) treatment, (4) prevention/gastric cancer and (5) H. pylori and the gut microbiota. The results of the individual working groups were presented for a final consensus voting that included all participants. Recommendations are provided on the basis of the best available evidence and relevance to the management of H. pylori infection in various clinical fields.

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Section: Wg 2: Diagnosticsmentioning

confidence: 99%

Management ofHelicobacter pyloriinfection: the Maastricht VI/Florence consensus report

Malfertheiner

Mégraud

Rokkas

et al. 2022

Gut

603

842

View full text Add to dashboard Cite

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“…Using the same HpSA test, a study conducted with 232 children in Northern Vietnam in 2008 reported a sensitivity of 96.6% compared to positive H. pylori culture and a specificity of 94.9% compared to negative serology (14). Another study in Spanish adults indicated a lower sensitivity of 72% and a similar specificity of 95% (16). However, using histological examination as the reference standard, a study conducted in Indonesia showed a sensitivity of 91.7% but a low specificity of 22.2% ( 17) while a study in Iraq found a low sensitivity of 36% but a specificity of 100% (18).…”

Section: Discussionmentioning

confidence: 99%

Helicobacter pylori Eradication Rate Using Stool Antigen Test in Vietnamese Children: A Prospective Multicenter Study

Nguyen,

Robert,

Pham

et al. 2023

JPGN Reports

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Objectives: This study assessed the diagnostic value of a monoclonal immunoassay stool antigen test (HpSA) for Helicobacter pylori (H. pylori) infection and the eradication outcomes. Methods: Children undergoing digestive endoscopy at 2 Children’s Hospitals in Ho Chi Minh City were recruited. Treatment was offered to H. pylori-infected children. Stool samples were collected on the same day as the endoscopy procedure and after 6 weeks post-treatment for HpSA. Diagnostic value and optimal cutoff of HpSA were assessed using biopsy-based tests as the gold standard. Eradication was defined as a negative HpSA post-treatment. Ethical approval was obtained, and informed consent was signed by the participants. Results: In total, 394 patients participated in the study. The most common symptoms were epigastric pain (74.6%) and vomiting (37.3%). H. pylori status was positive in 78% of patients (306/394), doubtful in 10.1%, and negative in 12.2%. HpSA was positive in 73.2% (142/194). Excluding doubtful infections, the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy of HpSA were 87.4%, 95.2%, 99.2%, 51.3%, and 88.4%, respectively. The optimal cutoff value of 0.148 provided similar accuracy to the recommended cutoff. The eradication rate was 56.1% in per-protocol analysis and 27.9% in intention-to-treat analysis. Treatment success was higher in boys, but lower among malnourished children and those infected with cagA+ strains. Conclusions: The HpSA is reliable for identifying H. pylori infection in epidemiological studies and assessing eradication outcomes. The low eradication rate highlights the need for an appropriate intervention strategy in Vietnamese children.

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“…Additionally, it is worth noting that the EIA-based test exhibits a diminished level of precision and specificity compared to that of the ICA-based test ( Shimoyama, 2013 ). Furthermore, the EIA-based test has a lower level of accuracy and specificity than that of the ICA-based test ( McNicholl et al., 2020 ). The accuracy of SATs can also be affected by gastrointestinal bleeding and antibiotics, similar to that for UBTs.…”

Section: Diagnostic Strategymentioning

confidence: 99%

“…For children, however, it is more effective to use monoclonal antibodies than polyclonal SAT (Zhou et al, (Shimoyama, 2013). Furthermore, the EIA-based test has a lower level of accuracy and specificity than that of the ICA-based test (McNicholl et al, 2020). The accuracy of SATs can also be affected by gastrointestinal bleeding and antibiotics, similar to that for UBTs.…”

Section: Non-invasive Examinationsmentioning

confidence: 99%

Helicobacter pylori infection: a dynamic process from diagnosis to treatment

Sun,

Yuan,

Zhou

et al. 2023

Front. Cell. Infect. Microbiol.

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Helicobacter pylori, a gram-negative microaerophilic pathogen, causes several upper gastrointestinal diseases, such as chronic gastritis, peptic ulcer disease, and gastric cancer. For the diseases listed above, H. pylori has different pathogenic mechanisms, including colonization and virulence factor expression. It is essential to make accurate diagnoses and provide patients with effective treatment to achieve positive clinical outcomes. Detection of H. pylori can be accomplished invasively and noninvasively, with both having advantages and limitations. To enhance therapeutic outcomes, novel therapeutic regimens, as well as adjunctive therapies with probiotics and traditional Chinese medicine, have been attempted along with traditional empiric treatments, such as triple and bismuth quadruple therapies. An H. pylori infection, however, is difficult to eradicate during treatment owing to bacterial resistance, and there is no commonly available preventive vaccine. The purpose of this review is to provide an overview of our understanding of H. pylori infections and to highlight current treatment and diagnostic options.

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Prospective, study comparing the accuracy of two different stool antigen tests (Premier Platinum HpSA and novel ImmunoCard STAT! rapid test) for the diagnosis of Helicobacter pylori infection

Cited by 7 publications

References 19 publications

Management ofHelicobacter pyloriinfection: the Maastricht VI/Florence consensus report

Management ofHelicobacter pyloriinfection: the Maastricht VI/Florence consensus report

Helicobacter pylori Eradication Rate Using Stool Antigen Test in Vietnamese Children: A Prospective Multicenter Study

Helicobacter pylori infection: a dynamic process from diagnosis to treatment

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