Comparison of the diagnostic values of the 3 different stool antigen tests for the noninvasive diagnosis of Helicobacter pylori infection.

To evaluate the accuracy of several methods aimed to detect Helicobacter pylori stool antigens in patients with upper gastrointestinal bleeding. Thirty-four patients with upper gastrointestinal bleeding because of peptic ulcer were included. The first stool sample during hospitalization was collected, and stool antigens were determined with: polyclonal enzyme-linked immunosorbent assay (Premier-Platinum-HpSA); monoclonal enzyme-linked immunosorbent assay (Amplified-IDEIA-HpStAR); and rapid monoclonal immunochromatographic test (ImmunoCard-STAT HpSA). A patient was considered infected when H. pylori was diagnosed with invasive tests (rapid urease test or histology) or with (13)C-urea breath test. When all tests were negative, a new breath test was repeated after stopping proton pump inhibitors. All patients were infected and, therefore, only sensitivity of the tests could be calculated: polyclonal enzyme-linked immunosorbent assay (74%), monoclonal enzyme-linked immunosorbent assay (94%), and rapid monoclonal immunochromatographic test (60%; concordance between the two observers was high, kappa = 0.9). Neither the presence of maelena nor the delay in obtaining stool samples explained false negatives. Neither the polyclonal enzyme-linked immunosorbent assay stool antigen test nor the rapid immunochromatographic stool antigen test can be recommended to diagnose H. pylori infection in patients with upper gastrointestinal bleeding. However, the monoclonal enzyme-linked immunosorbent assay stool antigen test is highly sensitive for detecting the infection in patients with this complication, although more studies are necessary to evaluate the specificity of the method.

The aim of the study was to compare 3 stool antigen tests for diagnosis of Helicobacter pylori infection in adult patients with dyspeptic complaints before eradication therapy. We compared 2...

Diagnostic tests for childhood Helicobacter pylori Infection: Invasive, Noninvasive or Both?

Several noninvasive diagnostic tests based on the detection of Helicobacter pylori stool antigen (HpSA) have been developed. The aim of the study was to compare the diagnostic accuracy of 5 HpSA tests-2 monoclonal enzyme immunoassay tests (EIAs: the Premier Platinum HpSA Plus test and Helicobacter pylori Antigen (Hp Ag) test) and 3 rapid immunochromatographic assay (ICA) tests (the ImmunoCard STAT! HpSA test, one step HpSA test, and H. pylori fecal antigen test)--for diagnosing H. pylori infection in adult patients with dyspeptic symptoms before eradication therapy. A total of 198 patients with dyspeptic symptoms were included in the study. A gastric biopsy was collected for histopathology and rapid urease testing. Stool specimens for HpSA testing were also collected. Patients were considered H. pylori positive if two invasive tests (histological and rapid urease tests) were positive. The sensitivity and specificity were 92.2% and 94.4%, respectively, for the Premier Platinum HpSA Plus test; 48.9% and 88.9%, respectively, for the HP Ag test; 86.7% and 88.9, respectively, for the One Step HpSA test; 68.9% and 92.6%, respectively, for the ImmunoCard STAT! HpSA test; and 78.9% and 87%, respectively, for the H. Pylori fecal antigen test. The Premier Platinum HpSA Plus EIA test was determined to be the most accurate stool test for diagnosing H. pylori infections in adult dyspeptic patients. The currently available ICA-based tests are fast and easy to use but provide less reliable results.

Background. The frequent occurrence of Helicobacter pylori infection requires significant health care resources after eradication therapy. Therefore the non‐invasive testing methods are required to alleviate the increased work‐load of health care personnel and to allow an easy control of eradication therapy. Conventionally, the effect of eradication therapy has been confirmed with 13C‐urea breath test 4–6 weeks after a completed eradication.Aim. To assess the applicability of Helicobacter pylori stool antigen tests as alternatives to the breath test in the control of the effect of eradication therapy.Methods. Fifty patients were diagnosed Helicobacter‐positive by endoscopy and histology as well as by rapid urease test from mucosal specimen. Four weeks after an eradication therapy the patients were subjected to 13C‐urea breath test as well as to faecal Helicobacter pylori antigen tests with mono‐ and polyclonal primary antibodies.Results. The monoclonal and polyclonal stool tests had 94% and 88% sensitivity, and 100% and 97% specificity, respectively, in the detection of Helicobacter pylori infection as compared to the 13C‐urea breath test. The non‐invasive test results were completely parallel in patients with various grades of mucosal atrophy or intestinal metaplasia.Conclusions. Monoclonal faecal Helicobacter pylori antigen test is slightly superior to the polyclonal test regarding the sensitivity in the detection of stool Helicobacter antigens. Due to their sufficient sensitivity and specificity, and to their practicability and cost‐effectiveness, they can be recommended for non‐invasive testing of Helicobacter pylori infection as alternatives to the 13C‐urea breath test.

Background and aim Helicobacter pylori (H. pylori) is the leading cause of human stomach infections. Accurate diagnosis is ucial for the effective management of H. pylori, leading to the eation of numerous diagnostic techniques, including both invasive and noninvasive methods. Methods This study thoroughly examines the diagnostic accuracy of the H. pylori Stool Antigen (HpSA) test in comparison to the rapid urease test (RUT). Background and aim HpSA test, known for being non-invasive, cost-effective, and quick, is contrasted with the fast but invasive RUT. Conducted on 100 adult patients from June to December 2022, the study utilized a comprehensive diagnostic approach, including medical history evaluations, physical exams, abdominal ultrasounds, laboratory tests, and careful stool sample collection. Additionally, all participants underwent RUT, stool antigen tests, and histopathology examinations. Results The findings revealed that the HpSA test identified more positive H. pylori cases (73) than the RUT (59) (P<0.01). Although RUT results closely matched histopathology outcomes, both RUT and histopathology showed greater accuracy than HpSA. Furthermore, RUT demonstrated higher sensitivity (98.2%) and accuracy (98.3%) compared with HpSA, while specificity was similar for both tests. Conclusion The HpSA test is a straightforward and noninvasive diagnostic method that is easy to use in laboratory settings. On the other hand, the RUT is known for its high accuracy and sensitivity. Together, these characteristics make the HpSA test a valuable alternative for diagnostic purposes.

<h3>Introduction</h3> <i>Helicobacter pylori</i>(HP) infection is causally associated with gastritis, peptic ulcer disease, mucosal associated lymphoid tissue and gastric malignancy. Current ‘test and treat’ guidelines for dyspepsia recommend the non-invasive testing by way of stool antigen test (SAT) for diagnosis of HP, prior to eradication therapy. We observed that in clinical practice most patients attending upper gastrointestinal endoscopy for dyspepsia have HP testing at endoscopy by way of CLO (<i>Campylobacter</i>-Like-Organism) test. There is increasing evidence, however, that the CLO test has lower diagnostic accuracy (sensitivity 80%, specificity 90%) in comparison to the SAT (sensitivity 96%, specificity 98%). We hypothesised that there was no additional diagnostic value in a CLO test, if a patient had already undergone stool antigen testing prior to endoscopy. <h3>Method</h3> A single centre (north London endoscopy unit), retrospective analysis of 98 consecutive patients who had undergone stool antigen testing prior to a CLO test at OGD, for the investigation of dyspeptic symptoms was undertaken. The electronic patient record was scrutinised to compare the result of the CLO test and SAT in these patients. Of those who were stool antigen positive, it was noted whether they were documented to have received eradication therapy prior to their endoscopy. <h3>Results</h3> A total of 81 out of 98 patients tested (82.7%), were SAT negative. Within the cohort of stool antigen negative patients, 98.8% were also CLO test negative (80/81). CLO testing in the presence of a negative SAT detected one additional case of <i>H. Pylori</i>infection (1.2%, 1/81). Within the cohort of SAT positive patients (17/98 total patients), 35.3% (6/17) were CLO test positive. Only one of these patients had not been documented to receive eradication therapy prior to their CLO test. <h3>Conclusion</h3> In our study, 96 of 98 patients (98.0%) did not directly benefit from CLO testing, following stool antigen testing. CLO testing provided new diagnosis of <i>H.pylori</i>infection in only 1 out of the 98 cases, where SAT had already been undertaken. This study proves our hypothesis to be valid in 99.0% of the cases reviewed. We recommend that a CLO test should not be performed at endoscopy, if the SAT result is already available. This will help reduce the financial cost of obtaining the CLO test (biopsy NHS tariff plus CLO test cost, equating to £40 per patient) and also reduce the administration time associated in documentation of the CLO test result. <h3>Disclosure of interest</h3> None Declared.

Various testing methods are successfully applied to the diagnosis of Helicobacter pylori infection, but noninvasive techniques are still needed for therapeutic monitoring, especially in children. In the search for new noninvasive techniques for the diagnosis of H. pylori infection, the authors evaluated an enzyme immunoassay for the detection of H. pylori antigen in stool (HpSA). The authors studied 62 H. pylori-positive children with chronic gastritis and 45 control subjects. H. pylori infection was diagnosed using cultures and histology of gastric biopsy specimens and a stool antigen test before treatment (clarithromycin, amoxicillin, omeprazole for 7 days) and 4 weeks to 6 weeks after treatment. Before therapy, antigen in stool was detected in 55 of 62 H. pylori-positive patients, which indicates that the sensitivity of the HpSA test was 88.7%. Of the 45 control subjects (with negative culture and histology results), 43 had negative results for H. pylori in the stool test (specificity, 95.5%). After completion of therapy, eradication was obtained (and confirmed by culture and histology) in 53 of the 62 H. pylori-positive children (85.5%). Four weeks to 6 weeks after eradication therapy, the sensitivity, specificity, positive predictive value, and negative predictive value of the stool antigen (HpSA) test were 88.9%, 96.2%, 80%, and 98%, respectively. The accuracy of the HpSA test for the detection of H. pylori in human stool 4 weeks to 6 weeks after treatment is comparable with the accuracy of the culture results. The stool antigen (HpSA) test was found to be a useful method for posttreatment eradication testing of infection in children.

ObjectiveReliable and readily available non-invasive methods are needed for detection of Helicobacter pylori infection and assessment of eradication therapy. In H. pylori-positive subjects we compared three stool antigen tests (Premier Platinum HpSA, Amplified IDEIA HpStAR and ImmunoCard STAT!HpSA) with invasive tests before their eradication therapy, and with non-invasive diagnostic methods after their therapy.Material and methodsA total of 82 adults with dyspepsia (aged 24–79 years) with an H. pylori-positive rapid urease test were enrolled in the study. Before therapy, H. pylori status was also confirmed with histology, culture and serology. After eradication, success was assessed with the [13C]-urea breath test (UBT) and usually also with serology.ResultsAt baseline, sensitivities of these stool antigen tests were 90.2% for HpSA, 97.6% for HpStAR and 96.3% for ImmunoCard. Eradication therapy was successful in 66 patients and unsuccessful in 16. Sensitivity and specificity of the three stool antigen tests in the post-eradication setting were, respectively, 75.0% and 95.5% for HpSA, 93.8% and 98.5% for HpStAR and 87.5% and 95.5% for Immunocard.ConclusionsThe performance of all three stool antigen tests in the post-treatment setting was slightly inferior to that of the UBT test and serology, with monoclonal antibody-based tests showing better results.

Diagnosis of Helicobacter pylori infection by stool antigen test in southern Taiwan.

Objective To discuss the clinical value of different methods in detecting helicobacter pylori (HP) infection.Methods 268 patients with digestive diseases were randomly selected by the method of generating random number through the computer,and detected by bacterial culture,rapid urease test (RUT) intrusion and silver staining,etc,invasive detection method,and using 13C-breath test(13C-UBT) and Helicobacter Pylon stool antigen detection,etc,non-invasive detection method,respectively.The positive detection rate and sensitivity,specificity,accuracy,positive predictive value and negative predictive value the difference was evaluated among the different methods.Results By comparing these methods of detecting HP infection,the specificity and accuracy of heavy silver staining method were 100.00％ and 97.01％,which were significantly higher than that of RUT and 13C-UBT(x2 =6.36,7.01,5.21,5.14,all P ＜ 0.05),Heavy silver staining method to detect positive predictive value was 100.00％,which were significantly higher than the 13C-UBT,negative predictive value was 89.19％,which were significantly higher than that of RUT method (x2 =6.04,6.34,all P ＜ 0.05),HP stool antigen test sensitivity,specificity,accuracy,positive predictive value were above 90.00％.Conclusion Sensitivity,specificity,accuracy rate,positive predictive value and negative predictive value of Heavy silver staining method and HP stool antigen test are high on detecting HP infection. Key words: Helicobacter pylori infection; Detection methods

Approaching Helicobacter pylori infection in children: Level I evidence at last and a word of caution

To assess the reliability of two different enzyme immunoassays in detecting the Helicobacter pylori status in stool specimens of Turkish patients with dyspepsia. One hundred and fifty-one patients [74 with nonulcer dyspepsia (NUD), 64 with duodenal ulcer (DU) and 13 with gastric cancer] who were admitted to the endoscopy unit of Istanbul University, Cerrahpasa Medical Faculty for upper gastrointestinal endoscopy because of dyspepsia were enrolled in the study. Helicobacter pylori infection was confirmed in all patients by histology, rapid urease test and culture. A patient was classified as being H. pylori-positive if the culture alone or both the histology and the rapid urease test were positive and as negative only if all of these tests remained negative. Stool samples were obtained from patients to assess the reliability of a monoclonal (FemtoLab H. pylori) and a polyclonal (Premier Platinum HpSA) stool antigen test and to compare the diagnostic accuracies of these two tests. A chi2 test was used for statistical comparisons. Using cut-off values of 0.19 for FemtoLab H. pylori and 0.16 for Premier Platinum HpSA, the sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy were 93%, 90%, 98%, 68% and 93% for the monoclonal test and 84%, 67%, 94%, 40% and 81% for the polyclonal test, respectively. The sensitivity, specificity, negative predictive value and diagnostic accuracy of the monoclonal test were significantly greater than those of the polyclonal test (chi2 = 3.98; p < .05 for sensitivity and chi2 = 15.67; p = .000 for specificity, chi2 = 15.78; p = .000 for negative predictive value and chi2 = 6.37; p = .012 for diagnostic accuracy). The bacterial load did not affect the sensitivity of either test. The monoclonal FemtoLab H pylori test, using a cut-off 0.19, is a very sensitive, specific and easy to perform diagnostic tool for the primary diagnosis of H. pylori infection in Turkish patients with dyspepsia.

Objective To analyze the diagnostic value of 13C respiratory test and fecal antigen test in children with Helicobacter pylori (Hp) infection. Methods Sixty-six children with gastrointestinal symptoms in the Department of Gastroenterology in Shanxi Provincial Children's Hospital from February 2017 to January 2019 were selected. All patients underwent Hp fecal antigen test (HpSA) and 13C urea breath test (13C-UBT). A gastroscopy was performed to confirm the diagnosis. Statistics of Hp infection in 66 children were analyzed and the diagnostic efficacy of HpSA and 13C-UBT was analyzed. Results Thirty-six patients were diagnosed as Hp-positive in 27 cases by gastroscopy, and Hp-negative in 38 cases, not sure for one case. One case of uncertainty was excluded from the diagnostic efficacy study, so that, 65 patients entered the diagnostic efficacy analysis. The diagnostic sensitivity of HpSA to Hp infection in 65 patients was 77.78% (21/27), the specificity was 92.11% (35/38), and the diagnostic accuracy was 86.15% (56/65). The 13C-UBT susceptibility rate was 96.30% (26/27), the specificity was 89.47% (34/38), and the diagnostic accuracy was 92.31% (60/65). The sensitivity of13C-UBT to Hp infection was higher than that of HpSA, and the difference was significant (χ2=4.103, P=0.043). Conclusions The results of13C-UBT test can effectively reflect the Hp status in the stomach of children, and its specificity and sensitivity are high. HpSA detection has the advantage of easy operation, moreover, it can be used as an auxiliary alternative to13C-UBT. Key words: Helicobacter pylori infection, children; Fecal antigen test; 13C breath test

The frequency of Helicobacter pylori (HP) infection in 208 patients with upper gastrointestinal tract symptoms from the Southern Province of Saudi Arabia was studied prospectively. The occurrence of HP was documented histologically and using a rapid urease test in antral endoscopic biopsies. Our results showed that 82.2% of the 208 patients included were positive for HP with a male:female ratio of approximately 1:1 (88:83). The age range was 14 to 80 years and the median age was 38.2 years. The frequencies of HP infection among Saudi and non-Saudi patients were 86% and 71%, respectively. Frequencies of HP infection were 88%, 77.5%, and 93% during the second, third, and fourth decades of life. Among the 140 patients with histologically proven antral gastritis, 128 cases (91%) were positive for HP whereas 29 cases (17%) of the 171 patients positive for HP did not show histologic evidence of antral gastritis. Our data showed that HP was present in 92.5% of patients with endoscopic diagnosis of duodenal ulceration, 81% of patients with duodenitis, 80% of patients with both duodenitis and gastritis, 69% of patients with gastric antral erythema, and 81% of patients with non-ulcer dyspepsia (normal upper gastrointestinal endoscopy). Histologically proven antral gastritis was seen in 80% of patients with endoscopic diagnosis of duodenal ulceration, 76% of patients with antral erythema, 70% of patients with both duodenitis and gastritis, 33% of patients with duodenitis only, and 66% of patients with non-ulcer dyspepsia. Among the 208 patients included in the study, gastric ulcerationw as only seen in two cases, both positive for HP.