Clinical Utility of Helicobacter pylori Stool Antigen Testing with a Bioluminescent Enzyme Immunoassay Using a Fecal Occult Blood Test Container.

Background A dedicated stool container is required for Helicobacter pylori stool antigen testing. If H. pylori fecal antigen can be measured from a fecal occult blood test container (S fecal collection container or S container), which is widely used for colorectal cancer screening, screening of the upper and lower gastrointestinal tract can be performed with a single stool sample. We investigated the clinical usefulness of an H. pylori stool antigen assay using an S container. Patients and Materials A total of 347 patients who underwent esophagogastroduodenoscopy (EGD) were included. After the procedure, H. pylori stool antigen was measured using the S container and collection container recommended for H. pylori stool antigen (BL-stool collection container or BL container), and the qualitative outcomes of each were compared. A bioluminescent enzyme immunoassay (BLEIA) was used to measure H. pylori stool antigen. Results The overall agreement between S containers and BL containers was 100% (347/347), indicating that the qualitative outcomes were equivalent. As a secondary analysis, the results of the S container samples were evaluated according to the diagnosis made by physicians, and the overall agreement rate was 99.7% (345/346), indicating a high correlation. Conclusion The detection of H. pylori stool antigen using the S container is clinically useful because the results are equivalent to those obtained by the usual method. Screening of the upper and lower gastrointestinal tract is expected to be possible with a single stool sample in the future.

Retrospective analysis of discordant results between histology and other clinical diagnostic tests on helicobacter pylori infection.

BACKGROUND: A reliable test is essential for diagnosing Helicobacter pylori (H. pylori) infection, and crucial for managing H. pylori-related diseases. Serving as an excellent method for detecting H. pylori infection, histologic examination is a test that clinicians heavily rely on, especially when complemented with immunohistochemistry (IHC). Additionally, other diagnostic tests for H. pylori, such as the rapid urease test (CLO test) and stool antigen test (SA), are also highly sensitive and specific. Typically, the results of histology and other tests align with each other. However, on rare occasions, discrepancy between histopathology and other H. pylori diagnostic tests occurs. AIM: To investigate the discordance between histology and other H. pylori tests, the underlying causes, and the impact on clinical management. METHODS: Pathology reports of gastric biopsies were retrieved spanning August 2013 and July 2018. Reports were included in the study only if there were other H. pylori tests within seven days of the biopsy. These additional tests include CLO test, SA, and H. pylori culture. Concordance between histopathology and other tests was determined based on the consistency of results. In instances where histology results were negative while other tests were positive, the slides were retrieved for re-assessment, and the clinical chart was reviewed. RESULTS: Of 1396 pathology reports were identified, each accompanied by one additional H. pylori test. The concordance rates in detecting H. pylori infection between biopsy and other tests did not exhibit significant differences based on the number of biopsy fragments. 117 discrepant cases were identified. Only 20 cases (9 with CLO test and 11 with SA) had negative biopsy but positive results in other tests. Four cases initially stained with Warthin-Starry turned out to be positive for H. pylori with subsequent IHC staining. Among the remaining 16 true discrepant cases, 10 patients were on proton pump inhibitors before the biopsy and/or other tests. Most patients underwent treatment, except for two who were untreated, and two patients who were lost to follow-up. CONCLUSION: There are rare discrepant cases with negative biopsy but positive in SA or CLO test. Various factors may contribute to this inconsistency. Most patients in such cases had undergone treatment.

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

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.

Diagnostic Accuracy of a Novel Stool Antigen Test for Helicobacter pylori Infection in a Medical Checkup Setting: A Prospective Cohort Study.

Objective Of the highly accurate tests for current Helicobacter pylori infection, the urea breath test (UBT) and stool antigen test (SAT) are noninvasive and do not require endoscopy. We conducted a prospective study to evaluate the accuracy of the newly developed SAT in a medical checkup setting. Methods The accuracy of the proposed SAT was examined by determining H. pylori infection status based on a history of eradication therapy, endoscopic H. pylori infection diagnosis, and blood tests (serum H. pylori antibody, serum PG II) in individuals undergoing esophagogastroduodenoscopy (EGD) during a health checkup. Results The new SAT showed 97.3% (108/111) sensitivity for those "currently infected," as well as 99.3% (530/534), 98.0% (402/410), and 98.7% (932/944) specificity for those "never infected," those "previously infected," and those "never/previously infected", respectively. Conclusion The newly developed H. pylori SAT may be useful for diagnosing H. pylori infection. Patients should be suspected of being infected even after H. pylori eradication if they have a high cutoff index in this test.

Accuracy of Stool Antigen Test in the Diagnosis of Helicobacter pylori Infection in the Dominican Republic.

Introduction: Helicobacter pylori is a well-studied infectious agent due to its pathogenic potential for peptic ulcers and gastric cancer. It has a high prevalence worldwide and has several diagnostic methods, both invasive and non-invasive. It is important to address the diagnostic efficacy of these tests, as the data vary by location and the specific population in which they are used. Therefore, an effective testing method should be obtained, evaluating the possibility of substantially reducing invasive procedures and, therefore, associated costs. OBJECTIVE: This study proposes to define the diagnostic accuracy of the stool antigen test for H. pylori infection in the Dominican Republic. METHODS: An observational, retrospective, and cross-sectional study was conducted. The results of the stool antigen test for H. pylori infection were compared with the results of the gastric biopsy, as a gold standard test. Patients over 18 years of age with an indication for endoscopy due to suspicion of H. pylori infection, who attended the gastroenterology clinic in 2021, were included in the study. RESULTS: It was shown that the stool antigen test for H. pylori infection has a 61.54% sensitivity and 59.65% specificity. According to the study population, the positive predictive value (PPV) was 67.60% and the negative predictive value (NPV) was 53.13%. CONCLUSION: Low numbers of both sensitivity and specificity were determined, which is why it is pertinent to study alternative non-invasive methods. However, it is important to assess the antibiotic exposure of the study population, since the diagnostic accuracy of the stool test can be influenced by this factor.

The use of non-invasive stool tests for verification of Helicobacter pylori eradication and clarithromycin resistance.

BACKGROUND: Clarithromycin resistance of Helicobacter pylori (H. pylori) represents a major challenge in eradication therapy. In this study, we assessed if non-invasive stool tests can be used to verify successful H. pylori eradication and determine clarithromycin resistance. MATERIALS AND METHODS: In this prospective study, patients undergoing urea breath testing (UBT) for confirmation of H. pylori eradication were asked to collect the stool as both a dry fecal sample and fecal immunochemical test (FIT). Stool H. pylori antigen testing (SAT) was performed on these samples and assessed for its accuracy in eradication verification. Type and duration of antibiotic treatment were retrospectively collected from patient records and compared with clarithromycin resistance determined by PCR of stool samples. RESULTS: H. pylori eradication information was available for a total of 145 patients (42.7% male, median age: 51.2). Successful eradication was achieved in 68.1% of patients. SAT on FIT samples had similar accuracy for eradication assessment compared to dry fecal samples, 72.1% [95% CI 61.4-81.2] versus 72.2% [95% CI 60.9-81.7]. Clarithromycin resistance rate was 13.4%. CONCLUSION: H. pylori antigen testing on FIT stool samples to verify H. pylori eradication is feasible and has similar accuracy as H. pylori antigen testing on dry stool samples. Dry stool, but not FIT, was suitable for non-invasive identification of H. pylori clarithromycin resistance by rt-PCR personalizing antibiotic treatment strategies without the need for invasive diagnostics is desirable, as the cure rate of first-line empirical H. pylori treatment remains low.

Comparison of the STANDARD F and SD BIOLINE stool antigen tests for diagnosis of Helicobacter pylori infection.

We compared the performance of the STANDARD F and SD BIOLINE stool antigen tests in 335 patients. The performance of STANDARD F (sensitivity: 95.6%; specificity: 94%) was highly comparable to that of SD BIOLINE (sensitivity: 92.6%; specificity: 93.5%), suggesting that STANDARD F is useful for the detection of Helicobacter pylori infection.

Evaluation of the effects of a proton pump inhibitor on Helicobacter pylori stool antigen testing.

BACKGROUND: Some patients find it difficult to discontinue proton pump inhibitors (PPIs). Unlike the 13 C-urea breath test (UBT), the stool antigen test (SAT), particularly when domestically produced kits are used, may be less likely to yield false-negative results. METHODS: This prospective study included a convenience series of 35 healthy Japanese subjects. Based on a statistical calculation, acceptable numbers of subjects were considered at least 21 and 11 with and without Helicobacter pylori (H. pylori) infection, respectively. The H. pylori infection was determined using the UBT or rapid urease test. SATs were performed with three novel domestically produced kits (the rapid immunochromatography tests Quick Navi™-H. pylori [Navi™] and Quick Chaser® H. pylori [Chaser®], and the bioluminescent enzyme immunoassay test BLEIA® 'EIKEN' H. pylori Antigen [BLEIA®]) before and after oral PPI administration (30 mg lansoprazole once daily for 14 days). For each kit, the sensitivities and specificities were calculated and compared before and after PPI administration. Furthermore, the cutoff index (COI) values of BLEIA® before and after PPI administration were compared in H. pylori-infected subjects. RESULTS: H. pylori infection was detected in 68.6% (24/35) of the included subjects. The sensitivities and specificities before versus after PPI administration were as follows: 79.2% (19/24) and 100.0% (11/11) versus 75.0% (18/24) and 100.0% (11/11) for Navi™, respectively (p = 1); 87.5% (21/24) and 100.0% (11/11) versus 75.0% (18/24) and 100.0% (11/11) for Chaser®, respectively (p = .371); 100.0% (24/24) and 100.0% (11/11) versus 95.8% (23/24) and 100.0% (11/11) for BLEIA®, respectively (p = 1). The median COI values of BLEIA® before and after PPI administration were 1389.0 and 3207.25, respectively (p = .0839). CONCLUSIONS: In stool specimens, H. pylori antigenicity is maintained even during PPI use. SAT using a bioluminescent enzyme immunoassay is particularly recommended because of its extremely high sensitivity.

Evaluation of a New Monoclonal Chemiluminescent Immunoassay Stool Antigen Test for the Diagnosis of Helicobacter pylori Infection: A Spanish Multicentre Study.

The stool antigen test (SAT) represents an attractive alternative for detection of Helicobacter pylori. The aim of this study was to assess the accuracy of a new SAT, the automated LIAISON® Meridian H. pylori SA based on monoclonal antibodies, compared to the defined gold standard 13C-urea breath test (UBT). This prospective multicentre study (nine Spanish centres) enrolled patients ≥18 years of age with clinical indication to perform UBT for the initial diagnosis and for confirmation of bacterial eradication. Two UBT methods were used: mass spectrometry (MS) including citric acid (CA) or infrared spectrophotometry (IRS) without CA. Overall, 307 patients (145 naïve, 162 with confirmation of eradication) were analysed. Using recommended cut-off values (negative SAT < 0.90, positive ≥ 1.10) the sensitivity, specificity, positive predictive value, negative predictive value and accuracy were 67%, 97%, 86%, 92% and 91%, respectively, obtaining an area under the receiver operating characteristic (ROC) curve (AUC) of 0.85. Twenty-eight patients, including seven false positives and 21 false negatives, presented a discordant result between SAT and UBT. Among the 21 false negatives, four of six tested with MS and 11 of 15 tested with IRS presented a borderline UBT delta value. In 25 discordant samples, PCR targeting H. pylori DNA was performed to re-assess positivity and SAT accuracy was re-analysed: sensitivity, specificity, positive predictive value, negative predictive value, accuracy and AUC were 94%, 97%, 86%, 99%, 97% and 0.96, respectively. The new LIAISON® Meridian H. pylori SA SAT showed a good accuracy for diagnosis of H. pylori infection.

An Updated Meta-Analysis of the Relationship Between Helicobacter pylori Infection and the Risk of Coronary Heart Disease.

Background: Coronary heart disease (CHD) is one of the leading causes of mortality in the world. Although the traditional risk factors for CHD have been identified, it seems that there are still many CHD cases without these factors. Previous studies have hypothesized that Helicobacter pylori (H. pylori) infection was associated with the risk of CHD. Objective: The association between H. pylori infection and the risk of CHD was studied using a systematic evaluation and meta-analysis method. Methods: In order to find relevant studies, four electronic databases were systematically searched until August 2021. According to the inclusion and exclusion criteria, studies were screened and data were extracted. Under the random-effects or the fixed-effects model, the odds ratio (OR) and 95% confidence interval (95% CI) were combined. All analyses were conducted using Review Manager software (RevMan 5.4). Results: Among the included studies, 2 studies were analyzed for H. pylori stool antigen test, 2 studies were analyzed for H. pylori histological staining test, 13 studies were analyzed for the anti-CagA test, and 38 studies were analyzed for the anti-H. pylori IgG test. The pooled results revealed that positive anti-H. pylori IgG was significantly associated with an increased risk of CHD (OR, 1.58; 95% CI: 1.34-1.87). Similarly, positive anti-CagA, positive H. pylori stool antigen, and positive H. pylori histological staining were significantly associated with the development of CHD with (OR: 1.33, 95% CI: 1.16-1.53), (OR: 3.50, 95% CI: 1.60-7.66), and (OR: 1.78, 95% CI: 1.12-2.83), respectively. Conclusion: This meta-analysis showed that H. pylori infection increased the risk of CHD. However, more studies are needed to further investigate whether early eradication of H. pylori may reduce the morbidity of CHD.

Helicobacter pylori Infection, Its Laboratory Diagnosis, and Antimicrobial Resistance: a Perspective of Clinical Relevance.

Despite the recent decrease in overall prevalence of Helicobacter pylori infection, morbidity and mortality rates associated with gastric cancer remain high. The antimicrobial resistance developments and treatment failure are fueling the global burden of H. pylori-associated gastric complications. Accurate diagnosis remains the opening move for treatment and eradication of infections caused by microorganisms. Although several reports have been published on diagnostic approaches for H. pylori infection, most lack the data regarding diagnosis from a clinical perspective. Therefore, we provide an intensive, comprehensive, and updated description of the currently available diagnostic methods that can help clinicians, infection diagnosis professionals, and H. pylori researchers working on infection epidemiology to broaden their understanding and to select appropriate diagnostic methods. We also emphasize appropriate diagnostic approaches based on clinical settings (either clinical diagnosis or mass screening), patient factors (either age or other predisposing factors), and clinical factors (either upper gastrointestinal bleeding or partial gastrectomy) and appropriate methods to be considered for evaluating eradication efficacy. Furthermore, to cope with the increasing trend of antimicrobial resistance, a better understanding of its emergence and current diagnostic approaches for resistance detection remain inevitable.

Helicobacter Pylori Treatment Eradication in Egypt: Standard Clarithromycin-based Triple versus Quadruple Regimen Therapy

Absence of adequate treatment for Helicobacter pylori (H. pylori) infection leads to prolonged life time colonization which is responsible for complications. Antibiotics resistance is the main cause of eradication failure in H. pylori infection, thus our study aimed to evaluate the efficiency and tolerability of standard triple therapy vs. quadruple regimen therapy in H. pylori eradication in Egypt.

Manejo de la infección por Helicobacter pylori en la edad pediátrica / Management of Helicobacter pylori infection in the pediatric age

El manejo de la infección por Helicobacter pylori en los niños es un dilema permanente en la práctica clínica. A lo largo de los años se han ido creando multitud de interrogantes respecto a los síntomas ligados a la infección, los métodos diagnósticos y los modos de tratamiento, siendo la más controvertida la indicación diagnóstica.En los últimos 10 años el colectivo pediátrico ha dispuesto de una guía elaborada por expertos de las Sociedades de Gastroenterología Pediátrica de Europa (ESPGHAN) y Estados Unidos (NASPGHAN) publicada en 2011 y actualizada en 2017 que nos ha orientado en el manejo de la infección por H.pylori en la edad pediátrica.El presente documento pretende unificar los criterios de indicación de estudio así como las pautas de diagnóstico y tratamiento de la infección por H.pylori en los niños y adolescentes para que puedan ser utilizadas tanto en atención primaria como en la clínica hospitalaria. (AU)

The management of Helicobacter pylori infection in children is a consistent problem in clinical practice. Over the years, many questions have been raised regarding symptoms associated with the infection, the diagnostic methods and type of treatment. What is most controversial is determining the criteria that enable us to initiate and carry out the study in children.In the last 10 years, pediatricians have followed the joint ESPGHAN/NASPGHAN guidelines published in 2011 and updated in 2017 in the management of H.pylori in children.This document aims to unify the study indication criteria as well as the diagnosis and treatment recommendations for H.pylori infection in children and adolescents, so they can be used in both Primary and Hospital care. (AU)

Management of Helicobacter pylori infection in the pediatric age.

The management of Helicobacter pylori infection in children is a consistent problem in clinical practice. Over the years, many questions have been raised regarding symptoms associated with the infection, the diagnostic methods and type of treatment. What is most controversial is determining the criteria that enable us to initiate and carry out the study in children. In the last 10 years, pediatricians have followed the joint ESPGHAN/NASPGHAN guidelines published in 2011 and updated in 2017 in the management of H. pylori in children. This document aims to unify the study indication criteria as well as the diagnosis and treatment recommendations for H. pylori infection in children and adolescents, so they can be used in both Primary and Hospital care.

Role of Helicobacter pylori eradication in patients with functional dyspepsia.

BACKGROUND: Helicobacter pylori (H. pylori) is implicated in the pathogenesis of functional dyspepsia (FD). There is conflicting data regarding the benefit of H. pylori eradication for symptom relief in FD. AIMS: To study the benefit of eradicating H. pylori in patients with FD as compared to standard medical treatment (SMT). Secondary aims were to find efficacy of H. pylori eradication therapy, recurrence of H. pylori after eradication, and predictors of efficacy. METHODS: Consecutive adult patients of FD (ROME IV) with H. pylori infection presenting in the outpatient department of our hospital were enrolled. Patients with Global Overall Symptom (GOS) scale > 2 and H. pylori infection were included. Patients were randomized into two groups: group 1 received H. pylori eradication therapy and group 2 received SMT. Treatment success was defined as symptom relief (GOS score < 2 and reduction by at least 2 points at 6 months) and H. pylori eradication was defined as stool antigen negative at 4 weeks. RESULTS: Of 329 participants with FD, 253 were H. pylori positive (rapid urease test and stool antigen test) (76.89%). After exclusions, 202 were randomized into two groups of 101 each. Thirty-two patients in group 1 and 31 in group 2 had treatment success (31.7% vs. 30.7%, p=1.000). The efficacy of H. pylori eradication therapy was 74.46% (70/94). H. pylori reinfection rate was 26.02% (19/73). CONCLUSIONS: H. pylori eradication therapy does not provide additional benefit in symptom relief in patients with FD as compared with SMT. TRIAL REGISTRATION: NCT04697641 (retrospectively registered on www.clinicaltrials.gov in January 2021).

Methods for detection of Helicobacter pylori from stool sample: current options and developments.

Accurate detection of Helicobacter pylori infection and determination of antibiotics have significant meaning in clinical practice. The detection methods can be categorized into two types, invasive and non-invasive, but nowadays we use the urease breath test most frequently which is non-invasive. However, many developing countries cannot meet the requirements for having specialized equipment and they lack trained personnel. Also, for the children, it is difficult to make them cooperate for the test. Methods that detect Helicobacter pylori from stool sample can be a promising alternative for detection used in children and mass screening. Stool antigen tests have several advantages such as rapidity, simplicity, and cheapness, though their results may be influenced by the heterogenicity of antigens, the nature of biochemical techniques, and the amount of antigen presented in the stool. PCR-based methods can specifically detect Helicobacter pylori infection and antibiotic resistance by targeting specific gene sequence, but they also are limited by the requirements of facilities and experts, the existence of inhibitory substance, and interference from the dead bacteria. Some novel methods also deserve our attention. Here we summarized the results of researches about methods using stool sample and we hope our work can help clinicians choose the appropriate test in clinical practice.

Evaluation of antibody immunochromatography testing for diagnosis of current Helicobacter pylori infection.

BACKGROUND: Helicobacter pylori infection represents a major gastrointestinal complaint associated with gastritis, gastric ulcer and stomach tumors. It is present in 90 % of developing countries population. H. pylori diagnosis in these countries, where resources are limited, is accomplished with simple non-invasive tests such as stool antigen and serum antibody tests. The aim of this study was to evaluate the serum antibody test in the diagnosis of current H. pylori infection. SUBJECT AND METHODS: A total of 117 patients were included in this prospective diagnosis accuracy testing study, who clinically presented with dyspepsia, heartburn, abdominal pain, diarrhea, or halitosis. A stool sample was collected from each patient and tested for H. pylori antigen using immunochromatographic method.Blood sample was also collected, half of which was EDTA-sampled and analyzed for complete blood count, while the remaining half was left to clot, the separated serum was tested for antibodies against H. pylori with immunochromatographic cassette. RESULTS: About 35 % of sixty six patients who were positive for stool antigen test gave a negative for serum antibodies test. Meanwhile, the non-consistent results within 51 negative stool antigen test patients was exhibited by 47 % of them. The discrepancies were not affected by age or disease duration. The calculated sensitivity, specificity, positive predictive value and negative predictive values were 50 %, 65 %, 65 % and 50 % respectively. CONCLUSION: The serum antibody test is not reliable in the diagnosis of current H. pylori infection. In developing countries, with limited facilities and primary care units, stool antigen test diagnosis is useful for diagnosis.

Current Helicobacter pylori Diagnostics.

The high prevalence of Helicobacter pylori and the variety of gastroduodenal diseases caused by this pathogen necessitate the use of only accurate methods both for the primary diagnosis and for monitoring the eradication effectiveness. There is a broad spectrum of diagnostic methods available for detecting H. pylori. All methods can be classified as invasive or non-invasive. The need for upper endoscopy, different clinical circumstances, sensitivity and specificity, and accessibility defines the method chosen. This article reviews the advantages and disadvantages of the current options and novel developments in diagnostic tests for H. pylori detection. The progress in endoscopic modalities has made it possible not only to diagnose precancerous lesions and early gastric cancer but also to predict H. pylori infection in real time. The contribution of novel endoscopic evaluation technologies in the diagnosis of H. pylori such as visual endoscopy using blue laser imaging (BLI), linked color imaging (LCI), and magnifying endoscopy is discussed. Recent studies have demonstrated the capability of artificial intelligence to predict H. pylori status based on endoscopic images. Non-invasive diagnostic tests such as the urea breathing test and stool antigen test are recommended for primary diagnosis of H. pylori infection. Serology can be used for initial screening and epidemiological studies. The histology showed its value in detecting H. pylori and provided more information about the degree of gastric mucosa inflammation and precancerous lesions. Molecular methods are mainly used in detecting antibiotic resistance of H. pylori. Cultures from gastric biopsies are the gold standard and recommended for antibiotic susceptibility tests.

[Management of Helicobacter pylori infection in the pediatric age]. / Manejo de la infección por Helicobacter pylori en la edad pediátrica.

The management of Helicobacter pylori infection in children is a consistent problem in clinical practice. Over the years, many questions have been raised regarding symptoms associated with the infection, the diagnostic methods and type of treatment. What is most controversial is determining the criteria that enable us to initiate and carry out the study in children. In the last 10 years, pediatricians have followed the joint ESPGHAN/NASPGHAN guidelines published in 2011 and updated in 2017 in the management of H.pylori in children. This document aims to unify the study indication criteria as well as the diagnosis and treatment recommendations for H.pylori infection in children and adolescents, so they can be used in both Primary and Hospital care.

Clinical performance of the H. PYLORI QUIK CHEK™ and H. PYLORI CHEK™ assays, novel stool antigen tests for diagnosis of Helicobacter pylori.

Infection with Helicobacter pylori is a global health issue, and rapid and accurate testing is a key to diagnosis. We aimed to assess the performance of two novel enzyme immunoassays (EIA), the H. PYLORI QUIK CHEK™ and the H. PYLORI CHEK™ assays, for the detection of H. pylori antigen in stool. Patients from five geographically diverse sites across the USA, Germany, and in Bangladesh were tested for infection with Helicobacter pylori with the two novel stool antigen tests and two commercially available stool antigen assays. All patients provided a stool sample and underwent esophagogastroduodenoscopy for biopsy. Results were compared to a clinical diagnosis using a composite reference method consisting of histological analysis and rapid urease testing of the biopsy. A total of 271 patients, 68.2% female and mean age of 46 years, were included. The overall prevalence of H. pylori infection was 24.1%. The sensitivity of the H. PYLORI QUIK CHEK™ and H. PYLORI CHEK™ was 92% and 91%, respectively. The specificity of H. PYLORI QUIK CHEK™ and H. PYLORI CHEK™ was 91% and 100%, respectively. No significant cross-reactivity against other gut pathogens was observed. The H. PYLORI QUIK CHEK™ and H. PYLORI CHEK™ assays demonstrate excellent clinical performance compared the composite reference method.