Comparative Accuracy of 3 Monoclonal Stool Tests for Diagnosis of<i>Helicobacter pylori</i>Infection among Patients with Dyspepsia

Calvet, Xavier; Lario, Sergio; Ramírez‐Lázaro, María José; Montserrat, A.; Quesada, Mariela; Reeves, Lynsey; Masters, Helen; Suárez-Lamas, David; Gallach, Marta; Sánchez-Delgado, Jordi; Martínez–Bauer, Eva; Miquel, Mireia; Junquera, Félix; Sanfeliú, Isabel; Segura, Ferrán

doi:10.1086/649860

Cited by 42 publications

(37 citation statements)

References 28 publications

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“…Por otra parte, como se señala más adelante, la fiabilidad diagnóstica de los distintos métodos de detección en heces varía en función del fabricante y de los aspectos técnicos, y los resultados en nuestro medio son ligeramente inferiores a los observados con la prueba del aliento 157,161,162 . Por esto y por la necesidad de validación local, se prefiere la prueba del aliento a las pruebas en heces como técnica de elección para diagnosticar de forma no invasiva la infección por H. pylori 161,162 .…”

Section: Recomendación B1unclassified

III Conferencia Española de Consenso sobre la infección por Helicobacter pylori

Gisbert¹,

Calvet²,

Bermejo³

et al. 2013

Gastroenterología y Hepatología

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Section: Recomendación B1unclassified

III Conferencia Española de Consenso sobre la infección por Helicobacter pylori

Gisbert¹,

Calvet²,

Bermejo³

et al. 2013

Gastroenterología y Hepatología

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“…These tests have been shown to have high sensitivity and specificity comparable with those of UBT. 6,7 The new Japanese guidelines also recommend stool antigen tests using monoclonal antibodies to examine the results of eradication therapy. 2 Two types of stool antigen tests have been widely used for the diagnosis of H. pylori infection: an enzyme immunoassay (EIA) and an assay based on immunochromatography.…”

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confidence: 99%

Characterization and usefulness of stool antigen tests using a monoclonal antibody to Helicobacter pylori catalase

Sato

Shimoyama

Takahashi

et al. 2012

J of Gastro and Hepatol

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Background and Aim: Two types of stool antigen tests have been used in the management of Helicobacter pylori infection. Testmate Pylori Antigen enzyme immunoassay (TPAg EIA) is a direct sandwich enzyme immunoassay (EIA) while Testmate Rapid Pylori Antigen (Rapid TPAg) is performed using immunochromatography. The aim of this study was to study the characterization and usefulness of these tests. Methods: Accuracy of both tests was studied using 111 fecal samples obtained from H. pylori-positive or -negative patients. Cross-reactivity was examined with four other Helicobacter spp. and five fecal bacteria in humans. To estimate the sensitivity of both kits, we tested H. pylori clinical strains. We also examined the diagnostic performances of both tests after the storage for 12 months. Results: The accuracy of both Testmate kits was 100% in fecal samples from 111 patients. No cross-reactivity was observed in both Testmate kits in five fecal bacteria and four other Helicobacter spp. TPAg EIA and Rapid TPAg showed positive results in 1342 of 1344, and 483 of 485 clinical strains, respectively. Diagnostic performances was maintained for 12 months when TPAg EIA was stored at 4°C and Rapid TPAg at 30°C. Conclusions:We examined the details of high accuracy of TPAg EIA and Rapid TPAg. The diagnostic performance of both kits was maintained after storage for up to 1 year. The two types of tests would be useful in the management of H. pylori infection.

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“…Different stool antigen tests using poly-or monoclonal antibodies are available. However, these test systems show relatively low sensitivities and specificities of 49 to 92% and 76 to 94%, respectively, as shown in recent studies by Calvet et al, Kesil et al, and Korkmaz et al (15,16,17). While stool antigen is the preferred test for use in children (18), its reliability and predictive value in adults are lower (19).…”

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A Novel Line Immunoassay Based on Recombinant Virulence Factors Enables Highly Specific and Sensitive Serologic Diagnosis of Helicobacter pylori Infection

Formichella

Romberg

Bolz

et al. 2013

Clin Vaccine Immunol

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g Helicobacter pylori colonizes half of the world's population, and infection can lead to ulcers, gastric cancer, and mucosa-associated lymphoid tissue (MALT) lymphoma. Serology is the only test applicable for large-scale, population-based screening, but current tests are hampered by a lack of sensitivity and/or specificity. Also, no serologic test allows the differentiation of type I and type II strains, which is important for predicting the clinical outcome. H. pylori virulence factors have been associated with disease, but direct assessment of virulence factors requires invasive methods to obtain gastric biopsy specimens. Our work aimed at the development of a highly sensitive and specific, noninvasive serologic test to detect immune responses to important H. pylori virulence factors. This line immunoassay system (recomLine) is based on recombinant proteins. For this assay, six highly immunogenic virulence factors (CagA, VacA, GroEL, gGT, HcpC, and UreA) were expressed in Escherichia coli, purified, and immobilized to nitrocellulose membranes to detect serological immune responses in patient's sera. For the validation of the line assay, a cohort of 500 patients was screened, of which 290 (58.0%) were H. pylori negative and 210 (42.0%) were positive by histology. The assay showed sensitivity and specificity of 97.6% and 96.2%, respectively, compared to histology. In direct comparison to lysate blotting and enzyme-linked immunosorbent assay (ELISA), the recomLine assay had increased discriminatory power. For the assessment of individual risk for gastrointestinal disease, the test must be validated in a larger and defined patient cohort. Taking the data together, the recomLine assay provides a valuable tool for the diagnosis of H. pylori infection.

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Comparative Accuracy of 3 Monoclonal Stool Tests for Diagnosis ofHelicobacter pyloriInfection among Patients with Dyspepsia

Abstract: Amplified IDEIA Hp StAR seems to be the most accurate stool test for diagnosing H. pylori for patients with dyspeptic symptoms. The currently available in-office tests obtain slightly less reliable results.

Cited by 42 publications

References 28 publications

III Conferencia Española de Consenso sobre la infección por Helicobacter pylori

III Conferencia Española de Consenso sobre la infección por Helicobacter pylori

Characterization and usefulness of stool antigen tests using a monoclonal antibody to Helicobacter pylori catalase

A Novel Line Immunoassay Based on Recombinant Virulence Factors Enables Highly Specific and Sensitive Serologic Diagnosis of Helicobacter pylori Infection

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