Detection Of Helicobacter Pylori Infection Research Articles

Diagnostic Approaches to Helicobacter pylori: A Comparative Study of Detection in Gastric Biopsy and Aspirates.

Background Helicobacter pyloriis one of the most common bacterial pathogens in humans. It is a microaerophilic bacteria with multiple unipolar flagella. It is associated with the development of various lesions like chronic gastritis, gastric ulcers, adenocarcinoma, and mucosa-associated lymphomas. The aim of this study was a comparative evaluation of the rapid urease test (RUT) and polymerase chain reaction (PCR) in gastric biopsy and aspirates for the detection ofH. pyloriinfection and to further determine the sensitivity and specificity of RUT and PCR. Method Endoscopic guided biopsy tissue and gastric aspirate specimens were collected from 110 patients with symptoms like gastritis, dyspepsia, etc., and subjected to RUT and PCR for detection ofH. pyloriinfection. Results A total of 110 samples, including both biopsy tissue (77) and gastric aspirate (33) were subjected to RUT and PCR. RUT for biopsy tissue showed the highest sensitivity (97.18%), compared to gastric aspirate (78.94%). Comparing RUT with PCR, the sensitivity and specificity of PCR were 93.33% and 90.0%, respectively. The positive predictive value (PPV) of PCR was 97.67%, the negative predictive value (NPV) was 75.0%, and the accuracy was 92.73%. Conclusion The present study showed that RUT is a rapid and accurate invasive test for the detection ofHelicobacter pyloriinfection in biopsy tissue as compared to gastric aspirate specimens, which are more sensitive to PCR. The study also showed that biopsy tissue was found to be a superior specimen for the detection ofHelicobacter pylorias compared to gastric aspirate.

Detection of Helicobacter pylori infection in children using rapid urease and histologic methods of diagnosis

Objective: The study aimed to detect the presence of Helicobacter pylori infection in children using two investigative methods: the rapid urease test and histological methods. It also examined the relationship between socioeconomic status and Helicobacter pylori infection.Design: This was a cross-sectional study conducted in the paediatric theatre at Korle Bu Teaching Hospital in Accra, Ghana.Participants: Children who were scheduled for upper gastrointestinal endoscopy were recruited into the study.Main outcome measures: The presence of Helicobacter pylori in gastric biopsies was measured using a rapid urease test and histology.Results: Seventy-three children aged 2 years to 16 years were seen during the period. Both tests were positive at the same time in 36 (49.3%) out of the 73 children (p<0.0001). The positivity rates for the rapid urease test and histology were 57.5% and 53.4 %, respectively. Significant predictors of the histology presence of H. pylori were a large household size of at least 6 members (AOR: 4.03; p<0.013) and the presence of pets at home (AOR: 3.23; p<0.044).Conclusions: Substantial agreement was found between the rapid urease test and histology examination of gastric biopsies for the presence of H. pylori. Children from large households and those with pets at home appear to have increased odds of having H. pylori infection of the gastric mucosa.

The real-time analysis of gastric juice (Endofaster) for detection of Helicobacter Pylori: a reliable tool in substitution of histology.

EndoFaster perform gastric juice analysis providing real-time Helicobacter pylori (HP) diagnosis during esophagogastroduodenoscopy (EGD), based on ammonium level. We aimed to assess its accuracy in detecting HP infection compared to the paired histology and to establish the optimum ammonium concentration cut-off point (COP). Consecutive adult outpatients referred for EGD were prospectively enrolled between December 2021 and March 2022. In-patients, those with surgically altered anatomy, suspected neoplasia, and bleeding were excluded. EndoFaster and histology were performed in all patients, with additional stool antigen test (SAT) reserved for discordant cases. EndoFaster diagnostic measures were calculated, and ammonium level COP established using AUROC curve analysis. 101 patients (64 female, mean age 56.7±16.1 years) were included. HP infection was diagnosed in 35 (34.6%) and 15 (14.8%) patients by EndoFaster and histology, respectively. Diagnostic accuracy in comparison with histology was 77.8% (95%CI 68.3% - 85.5%). After implementing SAT for gold standard assessment, EndoFaster accuracy increased to 81.6% (95%CI 72.5%-88.7%). AUROC curve (0.93±0.03, 95%CI 0.86-0.99) identified an ammonium COP of ≥67.5ppm. Using the new COP, EndoFaster accuracy further increased to 88.8% (95%CI 80.8%-94.2%). Endofaster showed high accuracy for HP detection, with moderate agreement to histology. An ammonium COP of 67.5 ppm seems to be the threshold with the highest accuracy for HP detection.

Simultaneous detection of Helicobacter pylori infection comparing between white light and image-enhanced endoscopy

BackgroundHelicobacter pylori (H. pylori) is associated with gastric cancer. Early and accurate diagnosis of H. pylori infection can reduce risk of gastric cancer. Conventional white light imaging (WLI) and image-enhanced endoscopic (IEE) techniques such as narrow-band imaging (NBI), linked color imaging (LCI) and blue laser imaging (BLI) plays pivotal role in H. pylori diagnosis. This study aimed to determine diagnostic performance of real-time endoscopy between WLI and other IEE techniques for diagnosis of H. pylori infection.MethodsThis prospective study compared endoscopic images by gastroscopy using WLI and IEE techniques (LCI, Magnifying-BLI, and Magnifying-NBI) at Thammasat University Hospital, Thailand between January 2020, and July 2021. All participants underwent gastroscopy. Three biopsies at gastric antrum and two biopsies at body were obtained for H.pylori diagnosis. H. pylori infection was defined as a positive test of either one of the following tests: rapid urease test, histopathology, H. pylori culture.ResultsOf 167 dyspeptic patients undergoing gastroscopy, 100 were enrolled in this study. Overall H. pylori infection was 40%. Patients had the mean age of 59.1 years and 53% were males. Enlarged gastric folds and antral nodularity can predict H. pylori infection with 100% PPV, while fundic gland polyps and red streak provided 100% PPV for exclusion of H. pylori infection on WLI. Sensitivity, specificity, PPV, NPV and accuracy for diagnosis of H. pylori infection for WLI were 80%, 71.7%, 65.3%, 84.3% and 75% respectively, while those for LCI were 90%, 70%, 66.7%, 91.3% and 78% respectively. M-NBI and M-BLI endoscopy demonstrated elongated pits in H. pylori-positive patients. Sensitivity, specificity, PPV, NPV and accuracy for M-BLI were 95%, 80%, 76%, 96% and 86% respectively, whereas those for M-NBI were 92.5%, 86.7%, 82.2%, 94.6% and 89% respectively. Sensitivity of M-BLI was better than WLI, while sensitivities of LCI and M-NBI were also numerically higher than WLI without statistical difference (M-BLI 95%vs.WLI 80%, p = 0.03; M-NBI 92.5%vs.WLI 80%, p = 0.13; LCI 90%vs.WLI 80%, p = 0.22). Sensitivities of all IEE modes were not different from one another (LCI 90%vs.M-BLI 95%, p = 0.50; LCI 90%vs.M-NBI 92.5%, p = 1.00, M-BLI 95%vs.M-NBI 92.5%, p = 1.00).ConclusionsM-BLI significantly improved sensitivity of real-time endoscopic diagnosis of H. pylori infection compared with WLI. Enlarged gastric folds and antral nodularity could be reliable predictors for H. pylori infection, while fundic gland polyps and red streak could be important endoscopic findings for H. pylori-negative mucosa.

Evaluation of the Fecal Antigen Rapid Test for Early Detection of Helicobacter Pylori Infection

Evaluation of the Fecal Antigen Rapid Test for Early Detection of Helicobacter Pylori Infection

Detection of Helicobacter pylori Infection in Human Gastric Fluid Through Surface-Enhanced Raman Spectroscopy Coupled With Machine Learning Algorithms

Diagnostic methods for Helicobacter pylori infection include, but are not limited to, urea breath test, serum antibody test, fecal antigen test, and rapid urease test. However, these methods suffer drawbacks such as low accuracy, high false-positive rate, complex operations, invasiveness, etc. Therefore, there is a need to develop simple, rapid, and noninvasive detection methods for H. pylori diagnosis. In this study, we propose a novel technique for accurately detecting H. pylori infection through machine learning analysis of surface-enhanced Raman scattering (SERS) spectra of gastric fluid samples that were noninvasively collected from human stomachs via the string test. One hundred participants were recruited to collect gastric fluid samples noninvasively. Therefore, 12,000 SERS spectra (n = 120 spectra/participant) were generated for building machine learning models evaluated by standard metrics in model performance assessment. According to the results, the Light Gradient Boosting Machine algorithm exhibited the best prediction capacity and time efficiency (accuracy = 99.54% and time = 2.61 seconds). Moreover, the Light Gradient Boosting Machine model was blindly tested on 2,000 SERS spectra collected from 100 participants with unknown H. pylori infection status, achieving a prediction accuracy of 82.15% compared with qPCR results. This novel technique is simple and rapid in diagnosing H. pylori infection, potentially complementing current H. pylori diagnostic methods.

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.

Improving the detection of Helicobacter pylori in biopsies of chronic gastritis: a comparative analysis of H&E, methylene blue, Warthin-Starry, immunohistochemistry, and quantum dots immunohistochemistry.

The objective of the study was to compare the consistency of various staining methods, including H&E, Methylene Blue, Warthin-Starry (W-S), Immunohistochemistry (IHC) and Quantum dots immunohistochemistry (QDs-IHC), in detecting Helicobacter pylori (HP) in cases of mild, moderate and severe chronic gastritis. Biopsy samples were obtained from 225 patients with chronic gastritis at the Department of Pathology, Yichang Central People's Hospital between January 2019 and October 2019. The presence of HP was detected using H&E, Methylene Blue, W-S, IHC, and QDs-IHC. The positive rates for HP detection using H&E, Methylene Blue, W-S, IHC, and QDs-IHC were 42.22%, 51.11%, 53.78%, 59.11%, and 58.67%, respectively. In cases of mild chronic gastritis, the consistency of test results between H&E, Methylene Blue, W-S, and QDs-IHC with IHC were Kappa=0.196, P=0.033, Kappa=0.706, P<0.001, Kappa=0.717, P<0.001, and Kappa=0.968, P<0.001, respectively. Similarly, in cases of moderate chronic gastritis, Kappa values between H&E, Methylene Blue, W-S, and QDs-IHC with IHC were 0.356, P<0.001, 0.655, P<0.001, 0.741, P<0.001, and 0.946, P<0.001, respectively. For cases of severe chronic gastritis, the Kappa values between the staining methods and IHC were 0.271, P=0.037, 0.421, P=0.002, 0.621, P<0.001, and 1, P< 0.001, respectively. The study showed that the positivity rate of IHC was significantly higher than that of H&E, Methylene Blue, and W-S in detecting HP infection in chronic gastritis cases. In terms of consistency with IHC, QDs-IHC was the most reliable staining method across all severity grades, while the agreement between H&E and IHC was poor, and that between Methylene Blue and W-S with IHC was average. Pathology departments may choose the most appropriate staining method based on their specific needs, considering the staining time, contrast, and cost of each method.

Urea Breath Testing to Detect Helicobacter pylori in Patients with Peptic Ulcer Bleeding During Proton Pump Inhibitor Treatment.

This was a descriptive study carried out from January to December 2021, at Quanzhou First Hospital, an affiliated hospital of Fujian Medical University, to investigate the efficacy of the urea breath test in detecting Helicobacter pylori infection in patients with peptic ulcer bleeding affected with proton pump inhibitors. A total of 77 patients with peptic ulcer bleeding, who underwent urea breath testing after active bleeding, were divided into two groups. The Helicobacter pylori infection positivity rate in patients with peptic ulcer bleeding was 66.2%. The time from bleeding to detection and from admission to detection was not significantly different between the Helicobacter pylori-positive and -negative groups (p=0.840 and 0.285, respectively). Even with high-dose proton pump inhibitor treatment, a urea breath test can be performed after peptic ulcer bleeding ceases and results in an acceptable positivity rate. There was no significant difference in the accuracy of Helicobacter pylori detection between the time from bleeding to testing and from admission to testing. Key Words: Peptic ulcer, Helicobacter pylori, Upper gastrointestinal bleeding, Urea breath test, Proton pump inhibitor.

RIDA®GENE Helicobacter pylori PCR on the ELITe InGenius System

PCR detection of Helicobacter pylori infection in gastric biopsies allows the detection of this bacterium and the mutations associated with macrolide resistance. The aim of this study was to evaluate the performance of RIDA®GENE H. pylori PCR (r-Biopharm) on the ELITe InGenius System (Elitech). Two hundred gastric biopsies were obtained. These biopsies were ground in nutrient broth. Two hundred microliters of this suspension was treated with proteinase K, and then, 200 µL was transferred to an ELITe InGenius sample tube and tested using RIDA®GENE H. pylori PCR reagents. In-house H. pylori PCR was used as a reference. The sensitivity of RIDA®GENE H. pylori PCR with ELITe InGenius was 100%, the specificity was 98% (95% confidence interval (CI), 95.3–100%), the PPV was 98% (95% CI, 95.3–100%), and the NPV was 100% for the detection of H. pylori. All of these parameters were 100% for the categorization of macrolide resistance. The adaptation of RIDA®GENE H. pylori PCR reagents on the ELITe InGenius System was successful. This PCR is easy to use on this system.

Analysis of Clinical Application of C13-urea Breath Test for Detection of Helicobacter Pylori Infection

Analysis of Clinical Application of C13-urea Breath Test for Detection of Helicobacter Pylori Infection

THE DIAGNOSTIC ACCURACY OF H. PYLORI CULTURE AND RAPID UREASE TEST IN THE DIAGNOSIS OF H.PYLORI INFECTION KEEPING HISTOPATHOLOGY AS THE GOLD STANDARD

Objective: The aim of this study was to determine the diagnostic accuracy of biopsy-based tests in the detection of Helicobacter Pylori infections keeping histopathology as a gold standard. Materials and Methods: This validation study was conducted from August 2018 to February 2019 at Khyber medical college, pathology department, Peshawar, and comprised biopsy samples of 87 patients obtained via endoscopy which was done at the gastrointestinal endoscopy department, Hayatabad medical complex (HMC). Patients with a history of prior antibiotics and PPIs were excluded from the study. Rapid urease test (RUT) and culture of gastroduodenal biopsies were validated against the histopathological examination of gastroduodenal mucosa. Results: Out of 87 patients, 57.47% (50/87) were male and 42.52% (37/87) were female patients with an age range of 18 -80 years and a mean age of 45 years. Endoscopic findings showed 64.36% (56/87) of patients with gastritis, duodenitis with 6.89% (6/87), peptic and duodenal ulcers with 22.98% (20/87), erosion with 4.59% (4/87) and adenocarcinoma of stomach with 2.29% (2/87). The sensitivity and specificity of culture were 45.45% and 90.7% respectively, while positive and negative predictive values were 62.5% and 83% respectively. The sensitivity and specificity of the rapid urease test (RUT) were 81.81% and 90% while positive and negative predictive values were 90% and 94% respectively. Conclusion: The sensitivity and specificity of the rapid urease test were 82 and 90% respectively, while that of culture was 45 and 91% respectively. Keys Words: Helicobacter Pylori, Gastritis, Rapid urease test, Adenocarcinoma  

Features of duodenogastric refl ux in gastric ulcer

At the moment the approach to the treatment of gastric ulcer (GU) does not depend on the location of the ulcer in one or another part of the stomach. We compared gastric secretion, duodenogastric refl ux characteristics and Helicobacter pylori infection in patients with “high” and “low” gastric ulcers. 96 patients with recurrent GU were examined; 71.9% of men and 28.1% of women. In 58 patients, a “high” localization of the ulcer was detected, and in 38 patients, a “low” (pyloroantral) ulcer was diagnosed. All patients underwent esophagogastroduodenoscopy and daily intragastric pH-metry prior to the appointment of antisecretory therapy. The data were compared with the results of healthy volunteers. The frequency of detection of Helicobacter pylori infection was comparable with diff erent localization of gastric ulcer. We were able to show that with “high” ulcers, intragastric acidity in terms of fundal and antral pH and its circadian dynamics were comparable to healthy people. With “high” ulcers, the frequency of duodenogastric refl ux was close to normal, but their total duration was higher due to an increase in the proportion of prolonged and high refl ux. With “low” gastric ulcers, we noted a very high and monotonous acidity in the body and antrum of the stomach, combined with a decrease in the frequency and duration of duodenogastric refl ux. Consequently, both “high” and “low” stomach ulcers suggest the appointment of antisecretory drugs. At the same time, the detection of “high” stomach ulcers associated with excessive duodenogastric refl ux can be considered as a basis for prescribing bismuth tricalium dicitrate, including as part of the Helicobacter pylori eradication therapy, or ursodeoxycholic acid.

The frequency of Helicobacter pylori infection in patients with rheumatoid arthritis and adult residents of the city of Tula

Currently, the list of microorganisms that have a possible connection with the development of rheumatoid arthritis continues to be updated. The role of not only traditional pathogens, but also representatives of conditionally pathogenic microflora is being actively studied. A number of domestic and foreign works demonstrate a high degree of Helicobacter pylori infection in patients with rheumatic diseases, including rheumatoid arthritis.The aim of the present study is to identify the frequency of detection of Helicobacter pylori infection in patients with rheumatoid arthritis and in adult residents of the city of Tula.Material and methods. The study included 3288 residents of Tula who do not have rheumatic diseases, and 119 patients with rheumatoid arthritis. To detect the infection, FEGDS was performed according to the generally accepted method with the taking of biopsies of the mucous membrane of the antrum and the stomach body, followed by verification of Helicobacter pylori using the Helpil-test test system.Results. According to the results of the data on the infection rate of residents of Tula without rheumatic diseases (n=3288), the largest percentage of infected (78.8%) was detected by an invasive method – express diagnosis of urease activity of the biopsy. The detection rate using a respiratory ammonia test and serological method was lower and amounted to 51.1 and 49.3%, respectively. In total, H. pylori was detected in 1692 people, which was 51.46%. Among patients with rheumatoid arthritis, Helicobacter pylori infection was 81.5%. Signs of damage to the mucous membrane of the upper gastrointestinal tract were often detected: superficial and subatrophic gastritis, single erosions.Conclusions. 1. Based on the study, it was found that the infection rate of Helicobacter pylori in patients with rheumatoid arthritis is at a fairly high level, not significantly different from that in residents without rheumatic diseases, when examined by an invasive method – express diagnosis of urease activity of the biopsy (81.5% and 78.8%, respectively). 2. Among patients with rheumatoid arthritis, there was a tendency to increase the frequency of infection with age and peak values in older age groups (r=0.37; p&lt;0.05). 3. The frequency of detection of erosive and ulcerative lesions of the gastrointestinal tract in infected and uninfected Helicobacter pylori patients with rheumatoid arthritis significantly differed (42.2 and 13.6%) (p=0.03). Key words: Tula population, rheumatoid arthritis, Helicobacter pylori infection&gt;˂ 0.05). 3. The frequency of detection of erosive and ulcerative lesions of the gastrointestinal tract in infected and uninfected Helicobacter pylori patients with rheumatoid arthritis significantly differed (42.2 and 13.6%) (p=0.03). 

Evaluation of Accuracy and Feasibility of a New-Generation Ultra-Rapid Urease Test for Detection of Helicobacter pylori Infection

Helicobacter pylori (Hp) infection can be diagnosed by invasive and noninvasive methods, and, among the former, Rapid Urease Tests (RUTs) are an important option. Accuracy and rapidity of results are fundamental for RUTs. The aim of the study is to prospectively evaluate the sensitivity, specificity and time to positivity of a new-generation ultra-rapid urease test (iNatal duo test) for Hp detection and compare the results with other available RUTs [CLO Test (Campylobacter-Like Organism Test), CP Test (Campylobacter pylori Test) and Pronto Dry]. Gastric biopsies were taken in consecutive patients undergoing upper endoscopy: two in the antrum and two in the body for histology, and one in the antrum and one in the body for each RUT. RUTs were read at 1, 5, 15, 30 and 60 min, 3 h and 24 h after biopsy insertion into the reagent. Histology was considered as “gold standard”. The performance of the tests was evaluated in patients not taking proton pump inhibitors (PPI) (n = 924) by calculation of sensitivity, specificity and positive and negative predictive value. Agreement rate (κ) for every RUT and histology was calculated and compared. The performance of the iNatal duo test was also tested in a subgroup of patients taking PPI (n = 198). Hp was positive in 225/924 patients (24.3%) not taking PPIs and in 56/198 (28.3%) who were taking PPIs. The iNatal duo test was more sensitive than the other RUTs for detecting Hp at every time point. The sensitivity at 5 min was 96.2% in patients not taking PPIs and 92.2% in patients taking PPIs. κ with histology was higher for the iNatal duo test than any other RUT (at 30 min: iNatal duo 0.99, CLO 0.60, CP 0.78, Pronto 0.85, at 15 min: iNatal duo 0.99, CLO 0.46, CP 0.63, Pronto 0.71). In a prospective study, the iNatal duo test demonstrated high accuracy and rapidity for Hp detection, both in patients with and without PPI therapy. This new generation of ultra-rapid urease test could be useful for the rapid and correct management of patients undergoing upper GI endoscopy for suspected Hp infection.

Comparison of Different Histological Staining Methods for Detection of Helicobacter pylori Infection in Gastric Biopsy.

Background: Helicobacter pylori gastritis affects two-thirds of the world's human population. Among various invasive and non-invasive tests, histology play a very important role in detecting H. pylori in gastric biopsies. In histology, for detection of H. pylori, we use different histological staining techniques like routine haematoxylin & eosin (H&E) stain, Giemsa stain, Gimenez stain, and periodic acid Schiff - Alcian blue (PAS-AB) stain.Objective: Aim of our study was to evaluate these different histopathological staining techniques for detecting H. pylori in gastric mucosal biopsies and to determine the sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy of H&E stain, Gemenez stain and PAS-AB in the detection of H. pylori in gastric biopsies using Giemsa stain as the reference standard.Materials and Methods: It was a prospective descriptive study design of 45 gastric biopsies of patients having gastritis. This study was conducted at Vivekananda Polyclinic and Institute of Medical Sciences over a period of one year, from March 2021 to February 2022. From each formalin-fixed paraffin-embedded block, four glass slides were prepared and stained with H&E stain, Giemsa stains, Gemenez stain, and PAS-AB stain to detect the presence/absence of H. pylori in gastric biopsies. Sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy were assessed.Results: Various staining techniques for detecting H. pylori in gastric mucosal biopsies were compared. In reference to Giemsa stain results, statistical analysis indicates that the diagnostic accuracy of the Gimenez stain, H&E stain, and PAS-AB stain were 95.6%, 91.1%, and 84.4% respectively. Gimenez stain is confirmed to be better than H&E stain and PAS-AB stain to detect H. pylori in 45 gastric biopsies of patients having gastritis. PAS-AB stain is the worst stain to detect H. pylori in gastric biopsies.Conclusion: Gimenez stain has higher diagnostic accuracy than PAS-AB stain in the detection of H. pylori in gastric biopsy. In fact, Gimenez stain has high sensitivity, specificity and diagnostic accuracy as compared to traditional H&E stain while PAS-AB stain has lower sensitivity, specificity and diagnostic accuracy. Thus, Gimenez stain is also recommended for the detection of H. pylori in gastric biopsy.

Significance of Various Diagnostic Methods for the Detection of Helicobacter Pylori Infection

Significance of Various Diagnostic Methods for the Detection of Helicobacter Pylori Infection

Evaluation of Anti-Helicobacter pylori IgG Antibodies for the Detection of Helicobacter pylori Infection in Different Populations.

Serological testing (immunoassay) for Helicobacter pylori (H. pylori) is widely available and inexpensive, and does not require medication modifications before testing. It can also determine the type of infection, which helps with clinical diagnosis and treatment, and guides the use of medication. However, the performance of immunoblotting for the detection of H. pylori infections in different populations has still not been fully evaluated. We performed a retrospective analysis of patients in the Health Examination Center and Outpatient Department, from November 2017 to September 2020, at Peking Union Medical College Hospital. All the subjects were tested with the 13C-urea breath test (13C-UBT) and for IgG antibodies. A total of 1678 participants, including 1377 individuals who had undergone physical examinations, were recruited. The results of the immunoassay were significantly different from those of the 13C-UBT for all the subjects and outpatients (p < 0.001). For the physical examinations of individuals, the agreement between the immunoassay and the 13C-UBT was 0.64 (95%CI: 0.59–0.68; p < 0.001), and the H. pylori immunoassay demonstrated a sensitivity and specificity of 74.24% and 90.45%, respectively, with a positive predictive value of 71.01% and negative predictive value of 91.76%. In addition, in patients with gastric mucosal atrophy or early gastric cancer, antibody typing tests can also detect infected patients with missed UBT. The prevalence of H. pylori in Beijing was 26.8%, and the serological positivity rate for H. pylori in the population of Beijing was about 31.7% (25.1% in the physical examination population). The rate of H. pylori antibody positivity among patients with allergic diseases was 73.5%, which is significantly higher than that of the non-allergic disease population (29.3%, p < 0.001). In conclusion, H. pylori antibody typing testing can be applied as a specific test in the healthy physical examination population, and the test can be performed with the remaining serum during the physical examination.

Automation of RIDA®GENE Helicobacter pylori PCR on the BD MAX™ System.

PCR detection of Helicobacter pylori infection in gastric biopsies allows the detection of this bacterium and the mutations associated with macrolide resistance. The aim of this study was to evaluate the performance of RIDA®GENE H. pylori PCR (r-Biopharm) on a BD MAX™ System (Becton Dickinson). Two hundred ten gastric biopsies obtained were included. These biopsies were ground in nutrient broth. Two hundred microliters of this suspension was treated with proteinase K; 200 µL was transferred to a BD MAX™ sample tube then tested using RIDA®GENE H. pylori PCR reagents. In-house H. pylori PCR was used as a reference. The sensitivity of RIDA®GENE H. pylori PCR with BD MAX™ was 100%, the specificity was 99.08% (95% confidence interval (CI), 97.21-100%), the PPV was 99.02% (95% CI, 97.09-100%), and the NPV was 100% for the detection of H. pylori. The sensitivity was 97.14% (95% CI, 93.87-100%), the specificity was 100%, the PPV was 100%, and the NPV was 98.48%(95% CI, 96.08-100%) for categorization of macrolides resistance. The adaptation of RIDA®GENE H. pylori PCR on the BD MAX™ System is of considerable interest for microbiologists who seek to establish this assay in their laboratories.

Useful Serum Pepsinogen Levels for Detecting Ongoing Helicobacter pylori Infection in Asymptomatic Subjects: A Cross-Sectional Study Based on 13C-urea Breath Test Findings.

The serum pepsinogen (PG) assay is used to screen subjects at high risk for gastric cancer. Currently, there are few studies on the PG levels for the detection of Helicobacter pylori infection. This study aimed to determine the PG assay findings for detecting ongoing infection. Asymptomatic subjects who underwent a 13C-urea breath test (13C-UBT) on the day of gastroscopy and serum assay for cancer screening were included. Subjects with a recent intake of acid suppressants or antibiotics, gastrectomy, or renal failure were excluded. H. pylori infection was defined as a positive 13C-UBT result. Among the 500 included subjects, 167 (33.4%) had current infection. The serum PG II levels of > 12.95ng/mL (area under the curve [AUC] = 0.930, sensitivity 86.5%, specificity 90.7%) and PG I/II ratios of < 4.35 (AUC = 0.875, sensitivity 86.8%, specificity 79.6%) were related to infection. The PG I/II ratios were inversely correlated with age (r = -0.160, p = 0.039). The cutoff values of PG I/II ratios were lower in older subjects aged ≥ 50years (< 4.05; AUC = 0.875, sensitivity 80.7%, specificity 88.2%) than in younger subjects aged < 50years (< 4.35; AUC = 0.873, sensitivity 77.4%, specificity 88.9%). Serum PG II levels > 12.95ng/mL and PG I/II ratios < 4.35 suggest ongoing infection in asymptomatic subjects; therefore, H. pylori confirmation tests (i.e., 13C-UBT) should be considered under these conditions. Stricter criteria are required in older subjects aged ≥ 50years (PG I/II ratio < 4.05) to detect ongoing infection than younger subjects.