Accuracy of the stool antigen test in the diagnosis of Helicobacter pylori infection before treatment and in patients on omeprazole therapy.

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.

Helicobacter pylori stool antigen (HpSA) test is a new tool for evaluating the H. pylori infection. The present study was carried out to investigate the clinical usefulness of the HpSA test in the evaluation of eradication therapy by comparing it with the (13)C-urea breath test (UBT). One hundred and five patients received eradication therapy for H. pylori. After more than 8 weeks, the success of the therapy was evaluated by the HpSA test and the UBT. Concordant results were regarded as a final diagnosis, but when the results were discordant, histological examination was carried out. Of the 105 patients receiving eradication therapy for H. pylori, 25 patients were regarded as H. pylori positive by the UBT and and 20 patients were regarded as H. pylori positive by the the HpSA test. Nine patients (8.6%) showed discordant results (seven cases with UBT(+) and HpSA(-), and two with UBT(-) and HpSA(+)). Five cases out of nine were ultimately judged as having a false-positive result of the UBT, and in these cases the UBT values were relatively low (below 10 per thousand). The final diagnostic accuracies of the UBT and the HpSA test were 94.3% (88.0-97.9%; 95% CI) and 97.1% (91.9-99.4%), respectively. When we used the HpSA test in cases with weakly positive UBT values, we were able to diagnose the correct status of H. pylori infection after eradication in 99% of all patients (94.8-100.0%). The HpSA test is a useful tool for the evaluation of eradication therapy and a combination of the HpSA test and UBT is clinically recommended.

The Helicobacter pylori stool antigen (HpSA) test is useful for initial diagnosis of H. pylori infection, but there is disagreement regarding its diagnostic accuracy after eradication therapy. The aim of the present study was to evaluate the diagnostic accuracy of the HpSA test before and after eradication therapy. One hundred and thirty-six patients underwent upper gastrointestinal endoscopy with biopsies for the diagnosis of H. pylori infection using culture, histology and the rapid urease test. Fifty-four H. pylori-positive patients were treated with 1-week triple therapy. Six to 10 weeks after the end of therapy, the patients underwent re-endoscopy and received the same biopsy-based methods. In addition, the 13C-urea breath test was performed. The HpSA test was performed before and 6-10 weeks after the end of therapy. In 23 patients, the HpSA test was also performed at the end of therapy. Before therapy, the sensitivity and specificity of the HpSA test was 98.3% (95% confidence interval (CI): 95.9-100%) and 95.0% (95% CI: 75.1-99.9%), respectively. At the end of therapy, the HpSA tests were all negative both for eradication and non-eradication patients. The sensitivity and specificity of the HpSA test after eradication therapy were 90% (95% CI: 55.5-99.7%) and 97.7% (95% CI: 93.3-100%), respectively. The HpSA test is a useful method for the diagnosis of H. pylori infection before and after eradication therapy.

To evaluate the accuracy of Helicobacter pylori (Hp) stool antigen test for diagnosing Hp infection. Articles related to diagnosis of Hp infection by Hp stool antigen test, published before March 2004, were retrieved in the databanks such as CBMdisc, CMCC, CNKI, and VIP. Related journals were searched manually. Meta-analysis was performed by SROC curve recommended by Diagnostic and Screening Group of the Cochrane Collaboration Web with the parameters such as sensitivity, specificity, accuracy, predictive values, and likelihood ratio. In total 19 studies including 3123 patients met the inclusion criteria. The sensitivity of Hp stool antigen for the diagnosis of Hp infection was 94% and its specificity was 93%. Helicobacter pylori stool antigen examination is a simple, noninvasive and highly accurate method in diagnosis of Hp infection.

To evaluate the Helicobacter pylori Stool Antigen (HpSA) test for the diagnosis of H. pylori infection in children. Prospective cohort study in an academic medical centre. A total of 106 consecutive children who underwent gastroscopy were included. Biopsy specimens were sampled from the gastric antrum and corpus for the assessment of H. pylori infection by culture and histology. A patient was defined to be H. pylori positive if the results of culture and/or histology proved to be H. pylori positive; a patient was defined to be negative if both test results were negative. All children provided a stool sample within 2 days of gastroscopy. H. pylori antigens in faeces were assessed by an enzyme immunoassay (Premier HpSA, Meridian Diagnostics, Inc., Cincinnati, OH, USA). The mean age of included patients was 8.5 years (range 1-18.5). Thirty patients were H. pylori positive and 76 patients were H. pylori negative. Using the recommended cut-off values of 0.140 optical density (OD) and 0.159 OD, sensitivity and specificity of 100% and 92% were found. The positive and negative predicting values were 83% (30/36) and 100% (70/70), respectively. The HpSA test is an accurate test for the diagnosis of H. pylori infection in children, and might therefore be a good alternative for diagnostic tests such as the 13C-urea breath test (UBT).

There are now many tests and pathological examinations to detect Helicobacter pylori (Hp), but most have disadvantages such as being invasive, expensive, or unobtainable for a widespread population. The Hp stool antigen (SA) test has been advocated as a safe and cost-effective method of diagnosing Hp. Thus, we conducted a prospective study to examine the reliability of the Helicobacter pylori stool antigen (HpSA) test. The subjects were 100 patients who underwent endoscopic manipulation at Istanbul Haseki Education and Research Hospital. Endoscopy specimens were studied by a pathologist, for routine pathological analysis and for the presence of Hp. Fecal specimens were studied using the HpSA test in the laboratory of the Department of Infectious Diseases at our hospital. The pathology results were compared with the HpSA test results, since pathological examination was the reference standard of our study. The Chi(2) test was used for statistical comparison of the values. According to the pathology results, Hp was present in 82 patients, whereas the HpSA test was positive in 77 patients and negative in 23 patients. The sensitivity, specificity, positive predictive value, and negative predictive value were 91%, 83%, 96%, and 65%, respectively. The HpSA test results were similar to the pathology results, with sensitivity and specificity of 91% and 83%, respectively. Thus, the HpSA test appears to be an effective method of detecting Hp in patients who are not candidates for endoscopy.

：Objective To assess theefficacy of Helicobacter pylori (Hp) stool antigen (HpSA) test for detection of Hpinfection.Methods The stool specimens collected ftom 353 patients with uppergastrointestinal symptoms were detected for HpSA by enzyme linked immunosorbent assay(ELISA) and enzyme immunoassay (EIA).The diagnostic accuracy of HpSA ELISA and EIA wereevaluated in comparion with the results of a ~(13)C-Urea breath test (~(13)C-UBT) whichwas defined as gold standard.The relative operating characteristic (ROC) curve wasconstructed by using parametric distribution-free (PDF) approach and non-parametricmethod.The area under the ROC curve was used to evaluate the value of HpSA test indiagnosis of Hp infection.Results The chi-square test showed that positive Hp infectionwas detected in 1 69 cases by ELISA,170 cases by EIA and 177 cases by ~(13)C-UBT with nosignificant difference (P>0.05).The coincidence of ELISA and EIA in detecting HpSA was98.58%(Kappa=0.97).The area under the ROC curve for ELISA detection of HpSA was 0.96 byPDF and 0.95 by non-parametric method,whereas it was 0.97 and 0.94,respectively,for EIAdetection of HpSA.The area under the ROC curve was significant higher for ELISA and EIAthan no diagnostic value of 0.50(P 0.05).Conclusions ROC curve,as a statistical tool,ismore objective and realistic in evaluating diagnostic tests.It is an accurate and reliabletest for HpSA detection by both EIISA and EIA.which is helpful in clinical practice.

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

To investigate the relationship between Helicobacter pylori infection and severe hyperemesis gravidarum (H. Gravidarum) by using Helicobacter pylori Stool Antigen (HpSA) and other serologic test results. Twenty-seven pregnant women with H. Gravidarum and 97 asymptomatic pregnant women of matching gestational age without gastric problems were enrolled in a prospective study. Serum samples collected from cases were investigated in terms of specific antibodies for H. pylori (immunoglobulin-IgG, IgA) and feces samples were investigated for HpSA. Statistical analysis of the data obtained from the groups was made by appropriate chi2 tests. Rate of HpSA positivity in patients with H. Gravidarum was 40.7%, while the same rate was 12.4% in the control group. The difference between the two groups was significant (P = 0.001). Rates of positivity for specific IgG formed against H. pylori in gravida with H. Gravidarum and in the asymptomatic gravida were 85.2% and 73.2%, respectively, and the rates for IgA were 48.1% and 41.2%, respectively. There was no difference between groups in terms of specific Igs formed against H. pylori (P > 0.05). The HpSA scan showed a statistically significant relation between H. pylori infection and H. Gravidarum. HpSA test gives more efficient, reliable and realistic results than specific Igs formed against H. pylori in the identification of H. pylori positivity in gravida with H. Gravidarum.

To determine the incidence of Helicobacter pylori (HP) stool antigen (HPSA) in patients with laryngopharyngeal reflux disease (LPRD), and to make a comparison of 2 treatment regimens that have been used based on the presence or absence of HPSA positivity in patients with LPRD. Randomized controlled study. Suez Canal University Hospital, Ismalia, Egypt. A total of 212 patients with symptoms of LPRD. Patients were evaluated by laryngoscopy, ambulatory pH monitoring for 24 hours, and HPSA testing. Esomeprazole magnesium as a monotherapy was evaluated vs triple therapy in patients with HP infection. To determine the incidence of HPSA in patients with LPRD, and to make a comparison of 2 treatment regimens that have been used based on the presence or absence of HPSA positivity in patients with LPRD. Persistent dry cough and a feeling of a lump in the throat (globus sensation) were the most frequent symptoms of LPRD, while posterior laryngeal inflammation was the main laryngoscopic finding. Results from the HPSA test were positive in 57% of the studied group. Patients with negative HPSA were treated with esomeprazole as single modality with a reported improvement score of 96.6%. Patients with positive HPSA test results were divided into 2 groups: 1 received only esomeprazole, with reported improvement in 40%, whereas the second group was treated with esomeprazole, plus amoxicillin sodium and clarithromycin (triple therapy) and reported a 90% incidence of symptom improvement. The incidence of HP infection in patients with LPRD in our study was 57%. Triple therapy showed a higher cure rate in patients with HPSA-positive test results.

A Helicobacter pylori stool antigen (HpSA) test has been proposed as a valid alternative to the 13C-urea breath test (13C-UBT) for the non-invasive detection of H. pylori infection in primary diagnosis. Published reports show conflicting results with regard to the test's diagnostic accuracy after eradication therapy. The aim of the present study was to assess the diagnostic value of the HpSA test and to determine the optimal discriminating cut-off value in patients following H. pylori eradication therapy. Stool samples were collected and the 13C-UBT was performed in 113 patients 4-6 weeks after eradication therapy. A validated test protocol for the 13C-UBT was used. Stool specimens were analysed with the Premier Platinum HpSA enzyme immunoassay (EIA). A receiver operator characteristics (ROC) analysis was performed to define the optimal cut-off value on the basis of the results of the 13C-UBT. The results of the 13C-UBT showed that H. pylori eradication was successful in 83/113 (73%) patients. According to the manufacturer, the cut-off value for the HpSA test is 0.14 optical density, but this does not appear to be valid after eradication therapy (sensitivity 76.7%, specificity 98.8%). On the basis of ROC analysis, the optimal cut-off value after therapy was determined to be 0.11 optical density, giving a sensitivity of 93.3% and a specificity of 93.9%. The HpSA test is a valid test for the assessment of H. pylori status after eradication therapy, provided an adjusted cut-off value is applied.

Introduction: Proton pump inhibitors (PPIs) can lead to false-negative results in Helicobacter pylori stool antigen (HpSA) testing. A new bioluminescent enzyme immunoassay (BLEIA)-based HpSA test was introduced. This study aimed to evaluate the sensitivity of this test in patients on PPIs and compare its sensitivity with that of the enzyme immunoassay (EIA). Methods: We included patients without a history of H. pylori eradication who were diagnosed as H. pylori-positive via culture, microscopy, rapid urease tests, urea breath tests, serum H. pylori antibody tests, or HpSA tests. The sensitivity of HpSA detection was compared among patients based on their PPI intake using both BLEIA and conventional EIA. Results: Enrollment occurred from December 2020 to July 2022 across 10 facilities, with 109 patients enrolled in both the PPI and non-PPI groups. The sensitivity of BLEIA was 65.9% in the PPI group and 87.1% in the non-PPI group, showing a difference of −22.0% (95% CI: −11.0% to −32.9%) (p = 0.0003). For EIA, the sensitivity was 54.1% in the PPI group and 72.4% in the non-PPI group, with a difference of −18.3% (95% CI: −5.5% to −30.4%) (p = 0.0076). Significant differences in sensitivity were observed for both BLEIA and EIA between the PPI and non-PPI groups (p = 0.005 and p < 0.0001, respectively), with BLEIA demonstrating higher sensitivity. Conclusion: This study indicated that the sensitivity of HpSA detection using BLEIA decreased under PPI administration. Additionally, BLEIA may have higher sensitivity than EIA.

Among several diagnostic tests, a Helicobacter pylori stool antigen (HpSA) test may offer a useful noninvasive method for diagnosing infection without sacrificing animals. In this study, male C57BL/6 mice (n=6) were infected with H. pylori ATCC 49503 (1×108 CFU/mouse) by intragastric inoculation three times at 2-day intervals, and H. pylori infected stool specimens were collected 1, 3, 5, 7, 14, 21 days after infection to assess reliability of the HpSA test. Five of six specimens were positive at 5-21 days after infection, and the sensitivity of the HpSA test was 83.33%. The presence of H. pylori infection was confirmed by the rapid urease test and genomic DNA polymerase chain reaction (PCR), and showed the same results as the HpSA. However, the rapid urease test and genomic DNA PCR are invasive tests and require animal sacrifice to detect H. pylori in gastric biopsy samples. We suggest that an HpSA test kit would be useful and effective for monitoring H. pylori in various laboratory animals, as H. pylori can be easily monitored without sacrificing animals.

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.

The diagnostic value of Helicobacter pylori stool antigen (HpSA) tests in elderly subjects remains unclear. The objective of this study was to assess the diagnostic accuracy of the immunochromatographic assay‐based HpSA test in a male elderly cohort and identify factors affecting the accuracy. Data for asymptomatic elderly male citizens (≥65 years old) who received health checkups at the Chinese PLA General Hospital between July 2007 and November 2018 were collected. The diagnostic accuracy of the HpSA test was determined using the 13C‐urea breath test as a reference standard. Associations between baseline comorbidities and the accuracy of the HpSA test were analyzed. In total, 316 participants were enrolled, including 193 in the pre‐treatment group (77.2 ± 7.8 years old) and 123 in the post‐treatment group (78.7 ± 8.3 years old). The accuracy (91.5%, 91.2%, and 91.9%) and specificity (97.6%, 98.7%, and 96.0%) were high in all participants, pre‐ and post‐treatment groups, respectively. However, sensitivities were only 68.7%, 65.1%, and 75.0%, respectively. In the pre‐treatment group, constipation was associated with decreased sensitivity (p = 0.039), while colorectal polyps were associated with increased sensitivity (p = 0.010). Multivariate analysis indicated that constipation and colorectal polyps are independent factors for the sensitivity of HpSA in the pre‐treatment group. The immunochromatographic assay‐based HpSA test achieved high accuracy with high specificity but suboptimal sensitivity in the elderly male cohort. Constipation and colorectal polyps were negatively and positively associated with HpSA sensitivity, respectively, in the pre‐treatment group.