BACKGROUND Helicobacter pylori(H.pylori)infection has been well-established as a significant risk factor for several gastrointestinal disorders.The urea breath test(UBT)has emerged as a leading non-invasive method for...BACKGROUND Helicobacter pylori(H.pylori)infection has been well-established as a significant risk factor for several gastrointestinal disorders.The urea breath test(UBT)has emerged as a leading non-invasive method for detecting H.pylori.Despite numerous studies confirming its substantial accuracy,the reliability of UBT results is often compromised by inherent limitations.These findings underscore the need for a rigorous statistical synthesis to clarify and reconcile the diagnostic accuracy of the UBT for the diagnosis of H.pylori infection.AIM To determine and compare the diagnostic accuracy of 13C-UBT and 14C-UBT for H.pylori infection in adult patients with dyspepsia.METHODS We conducted an independent search of the PubMed/MEDLINE,EMBASE,and Cochrane Central databases until April 2022.Our search included diagnostic accuracy studies that evaluated at least one of the index tests(^(13)C-UBT or ^(14)C-UBT)against a reference standard.We used the QUADAS-2 tool to assess the methodo-logical quality of the studies.We utilized the bivariate random-effects model to calculate sensitivity,specificity,positive and negative test likelihood ratios(LR+and LR-),as well as the diagnostic odds ratio(DOR),and their 95%confidence intervals.We conducted subgroup analyses based on urea dosing,time after urea administration,and assessment technique.To investigate a possible threshold effect,we conducted Spearman correlation analysis,and we generated summary receiver operating characteristic(SROC)curves to assess heterogeneity.Finally,we visually inspected a funnel plot and used Egger’s test to evaluate publication bias.endorsing both as reliable diagnostic tools in clinical practice.CONCLUSION In summary,our study has demonstrated that ^(13)C-UBT has been found to outperform the ^(14)C-UBT,making it the preferred diagnostic approach.Additionally,our results emphasize the significance of carefully considering urea dosage,assessment timing,and measurement techniques for both tests to enhance diagnostic precision.Nevertheless,it is crucial for researchers and clinicians to evaluate the strengths and limitations of our findings before implementing them in practice.展开更多
In this editorial,we discuss the article in the World Journal of Gastroenterology.The article conducts a meta-analysis of the diagnostic accuracy of the urea breath test(UBT),a non-invasive method for detecting Helico...In this editorial,we discuss the article in the World Journal of Gastroenterology.The article conducts a meta-analysis of the diagnostic accuracy of the urea breath test(UBT),a non-invasive method for detecting Helicobacter pylori(H.pylori)infection in humans.It is based on radionuclide-labeled urea.Various methods,both invasive and non-invasive,are available for diagnosing H.pylori infection,inclu-ding endoscopy with biopsy,serology for immunoglobulin titers,stool antigen analysis,and UBT.Several guidelines recommend UBTs as the primary choice for diagnosing H.pylori infection and for reexamining after eradication therapy.It is used to be the first choice non-invasive test due to their high accuracy,specificity,rapid results,and simplicity.Moreover,its performance remains unaffected by the distribution of H.pylori in the stomach,allowing a high flow of patients to be tested.Despite its widespread use,the performance characteristics of UBT have been inconsistently described and remain incompletely defined.There are two UBTs available with Food and Drug Administration approval:The 13C and 14C tests.Both tests are affordable and can provide real-time results.Physicians may prefer the 13C test because it is non-radioactive,compared to 14C which uses a radioactive isotope,especially in young children and pregnant women.Although there was heterogeneity among the studies regarding the diagnostic accuracy of both UBTs,13C-UBT consistently outperforms the 14C-UBT.This makes the 13C-UBT the preferred diagnostic approach.Furthermore,the provided findings of the meta-analysis emphasize the significance of precise considerations when choosing urea dosage,assessment timing,and measurement techniques for both the 13C-UBT and 14C-UBT,to enhance diagnostic precision.展开更多
AIM: To validate and compare the cost of microdose ^14C urea breath test (UBT) with histology and rapid urease test for the diagnosis of H Py/ori. METHODS: Ninety-four consecutive patients with dyspeptic symptoms ...AIM: To validate and compare the cost of microdose ^14C urea breath test (UBT) with histology and rapid urease test for the diagnosis of H Py/ori. METHODS: Ninety-four consecutive patients with dyspeptic symptoms undergoing gastroscopy were enrolled. Gastric biopsies were taken for histology and rapid urease test. UBT was performed after gastroscopy by microdose ^14 urea capsules. Sensitivity, specificity and accuracy of UBT were calculated and compared with histology and rapid urease test. Cost comparison of these tests was also performed. RESULTS: H pylori was diagnosed by histology and rapid urease test in 66 (70%) and 61 (65%) patients, while ^14C UBT detected infection in 63 (67%). Accuracy of UBT was 93% in comparison with histology while its positive and negative predictive values were 97% and 84%, respectively. Comparison of ^14C UBT with rapid urease test gives an accuracy of 96%, with positive and negative predictive values of 95% and 97%, respectively. These results were highly reproducible with a Kappa test (P value 〈 0.001). Cost of histology or rapid urease test with gastroscopy was 110 USD or 95 USD respectively while the cost of UBT was 15 USD.CONCLUSION: Microdose ^14C UBT was comparable to histology and rapid urease test. ^14C UBT is an economical, self sufficient and suitable test to diagnose active Hpylori infection in less developed countries.展开更多
AIM To determine the sensitivity and specificity of the ^(13)C-urea breath test(UBT) in patients taking proton pump inhibitors(PPIs), using a new test meal Refex. METHODS One hundred and fourteen consecutive patients ...AIM To determine the sensitivity and specificity of the ^(13)C-urea breath test(UBT) in patients taking proton pump inhibitors(PPIs), using a new test meal Refex. METHODS One hundred and fourteen consecutive patients with dyspepsia, 53 Helicobacter pylori(H. pylori) positive, 49 H. pylori negative, were included in the study. The patients were then given esomeprazole 40 mg for 29 consecutive days, and the ^(13)C-UBT with the new test meal was performed the next morning. RESULTS The sensitivity of the ^(13)C-UBT with a cut off 2.5‰ was92.45%(95%CI: 81.79%-97.91%) by per-protocol(PP) analysis and 78.13 %(95%CI: 66.03%-87.49%) by intention-to-treat(ITT) analysis. The specificity of the ^(13)C-UBT test was 96.00 % in the ITT population(95%CI: 86.29%-99.51%) and 97.96% in the PP population(95%CI: 89.15%-99.95%).CONCLUSION The new test meal based ^(13)C-UBT is highly accurate in patients on PPIs and can be used in those unable to stop their PPI treatment.展开更多
AIM: Urea breath test (UBT) is a non-invasive diagnostic test for detecting the presence of Helicobacter pylori(H pylori).In this study we evaluated the effect of anti-tuberculosis therapy on the results of 14C-UBT.ME...AIM: Urea breath test (UBT) is a non-invasive diagnostic test for detecting the presence of Helicobacter pylori(H pylori).In this study we evaluated the effect of anti-tuberculosis therapy on the results of 14C-UBT.METHODS: Patients, with the diagnosis of tuberculosis (TB) who had a positive UBT at the point of starting antiTB therapy, were included. None had a history of peptic ulcer disease or had taken antibiotics, bismuth compounds and/or PPI in the previous month, 14C-UBT was repeated at the end of the second month and the end of treatment period and one month after completion of treatment course.RESULTS: Thirty-five patients (23 males) were enrolled.14C-UBT was negative in all 35 patients (100%) at the end of the second month and remained negative in 30cases (85.7%) at the end of the treatment course. One month after completion of treatment course, UBT remained negative in 13 patients (37.1%).CONCLUSION: Our report underscores the need for caution while interpreting urea breath test results in patients undergoing anti-TB therapy. Furthermore, the combination of drugs used in this study resulted in H pylori eradication in a minority of patients.展开更多
AIM: To evaluate the agreement between a mAb-based stool test (HP STAR) and the urea breath test (UBT) in monitoring (H pylon) infection after eradication therapy. METHODS: Patients with discordant results on ...AIM: To evaluate the agreement between a mAb-based stool test (HP STAR) and the urea breath test (UBT) in monitoring (H pylon) infection after eradication therapy. METHODS: Patients with discordant results on UBT and Hp STAR underwent endoscopy with biopsies for rapid urease test, culture, and histology to confirm H pylori status. RESULTS: Among 250 patients (50±14 years), 240 (96.0%) had concordant UBT and Hp STAR tests with a significant correlation between DOB and A values (R = 0.87; P〈0.0001). The remaining 10 (4.0%) patients had discordant tests (positive Hp STAR and negative UBT) with the Hp STAR inaccurate in five cases (false positive) and UBT inaccurate in the other five cases (false negative). The “maximal expected” sensitivity, specificity, +PV, -PV, +LR, and -LR were 91%, 100%, 100%, 97.4%, ∞, and 8.2 respectively, for the UBT, and 100%, 97.4%, 91%, 100%, 38.8, and 0, respectively, for the Hp STAR. Overall accuracy for both tests was 98%. CONCLUSION: Both the UBT and the Hp StAR are equally accurate in monitoring H pylori infection. Nowadays, the choice of the “best” non-invasive H pylori test in the post-treatment setting should be done not only in terms of diagnostic accuracy but also in view of cost and local facilities.展开更多
We evaluated the efficacy and tolerability of a dual therapy with rabeprazole and amoxicillin (AMX) as an empiric third-line rescue therapy. In patients with failure of first-line treatment with a proton pump inhibito...We evaluated the efficacy and tolerability of a dual therapy with rabeprazole and amoxicillin (AMX) as an empiric third-line rescue therapy. In patients with failure of first-line treatment with a proton pump inhibitor (PPI)- AMX-clarithromycin regimen and second-line treatment with the PPI-AMX-metronidazole regimen, a third-line eradication regimen with rabeprazole (10 mg q.i.d.) and AMX (500 mg q.i.d.) was prescribed for 2 wk. Eradication was confirmed by the results of the 13C-urea breath test (UBT) at 12 wk after the therapy. A total of 46 patients were included; however, two were lost to followup. The eradication rates as determined by per-protocol and intention-to-treat analyses were 65.9% and 63.0%,respectively. The pretreatment UBT results in the subjects showing eradication failure; those patients showing successful eradication comprised 32.9 ± 28.8 permil and 14.8 ± 12.8 permil, respectively. The pretreatment UBT results in the subjects with eradication failure were significantly higher than those in the patients with successful eradication (P = 0.019). A low pretreatment UBT result (≤ 28.5 permil) predicted the success of the eradication therapy with a positive predictive value of 81.3% and a sensitivity of 89.7%. Adverse effects were reported in 18.2% of the patients, mainly diarrhea and stomatitis. Dual therapy with rabeprazole and AMX appears to serve as a potential empirical third-line strategy for patients with low values on pretreatment UBT.展开更多
AIM: To quantitatively summarize and appraise the available evidence of urea breath test(UBT) use to diagnose Helicobacter pylori(H. pylori) infection in patients with dyspepsia and provide pooled diagnostic accuracy ...AIM: To quantitatively summarize and appraise the available evidence of urea breath test(UBT) use to diagnose Helicobacter pylori(H. pylori) infection in patients with dyspepsia and provide pooled diagnostic accuracy measures.METHODS: We searched MEDLINE, EMBASE, Cochrane library and other databases for studies addressing the value of UBT in the diagnosis of H. pylori infection. We included cross-sectional studies that evaluated the diagnostic accuracy of UBT in adult patients with dyspeptic symptoms. Risk of bias was assessed using QUADAS(Quality Assessment of Diagnostic Accuracy Studies)-2 tool. Diagnostic accuracy measures were pooled using the random-effects model. Subgroup analysis was conducted by UBT type(13C vs 14C) and by measurement technique(Infrared spectrometry vs Isotope Ratio Mass Spectrometry).RESULTS: Out of 1380 studies identified, only 23 met the eligibility criteria. Fourteen studies(61%) evaluated 13 C UBT and 9 studies(39%) evaluated 14 C UBT. There was significant variation in the type of reference standard tests used across studies.Pooled sensitivity was 0.96(95%CI: 0.95-0.97) andpooled specificity was 0.93(95%CI: 0.91-0.94). Likelihood ratio for a positive test was 12 and for a negative test was 0.05 with an area under thecurve of 0.985. Meta-analyses were associated with a significant statistical heterogeneity that remained unexplained after subgroup analysis. The included studies had a moderate risk of bias.CONCLUSION: UBT has high diagnostic accuracy for detecting H. pylori infection in patients with dyspepsia. The reliability of diagnostic meta-analytic estimates however is limited by significant heterogeneity.展开更多
AIM: To verify whether there is a gender difference in the 13C-urea breath test results in a large cohort. METHODS: The test results of dyspeptic patients referred for 13C-urea breath testing between January and Decem...AIM: To verify whether there is a gender difference in the 13C-urea breath test results in a large cohort. METHODS: The test results of dyspeptic patients referred for 13C-urea breath testing between January and December, 2007 were evaluated. Testing was carried out at the health insurance organization branches and evaluated at a central laboratory in Israel. RESULTS: Of a total of 28 746 test results, 18 122 (63.04%) were from females and 10 624 (36.95%) from males. Overall, 10 188 (35.4%) results [expressed as delta over baseline (DOB)] were positive (DOB 13C > 5), 18,326 (63.7%) were negative (DOB 13C < 3.5) and 232 (0.8%) were borderline (DOB 13C 3.5-5). There was a significant difference between the total positive rate among females and males (34.8% vs 37.2%, respectively, P = 0.0003). The mean test value was increased by approximately 10 units for females compared to males (P < 0.01) and this difference was consistent for all age groups (i.e., between 10-80 years of age, P < 0.01). CONCLUSION: More females were referred to 13C-urea breath testing. More males had positive results. The mean test values were significantly higher among females of all age groups, possibly representing an increased bacterial load among females and suggesting gender-associated differences in Helicobacter pylori host interactions.展开更多
AIM: To investigate whether posture affects the accuracy of 13C-urea breath test(13C-UBT) for Helicobacter pylori(H. pylori) detection in partial gastrectomy patients. METHODS: We studied 156 consecutive residual stom...AIM: To investigate whether posture affects the accuracy of 13C-urea breath test(13C-UBT) for Helicobacter pylori(H. pylori) detection in partial gastrectomy patients. METHODS: We studied 156 consecutive residual stomach patients, including 76 with H. pylori infection(infection group) and 80 without H. pylori infection(control group). H. pylori infection was confirmed if both the rapid urease test and histology were positive during gastroscopy. The two groups were divided into four subgroups according to patients' posture during the 13C-UBT: subgroup A, sitting position; subgroup B, supine position; subgroup C, right lateral recumbent position; and subgroup D, left lateral recumbent position. Each subject underwent the following modified 13C-UBT: 75 mg of 13C-urea(powder) in 100 m L of citric acid solution was administered, and a mouth wash was performed immediately; breath samples were then collected at baseline and at 5-min intervals up to 30 min while the position was maintained. Seven breathsamples were collected for each subject. The cutoff value was 2.0‰.RESULTS: The mean delta over baseline(DOB) values in the subgroups of the infection group were similar at 5 min(P > 0.05) and significantly higher than those in the corresponding control subgroups at all time points(P < 0.01). In the infection group, the mean DOB values in subgroup A were higher than those in other subgroups within 10 min and peaked at the 10-min point(12.4‰± 2.4‰). The values in subgroups B and C both reached their peaks at 15 min(B, 13.9‰± 1.5‰; C, 12.2‰± 1.7‰) and then decreased gradually until the 30-min point. In subgroup D, the value peaked at 20 min(14.7‰± 1.7‰). Significant differences were found between the values in subgroups D and B at both 25 min(t = 2.093, P = 0.043) and 30 min(t = 2.141, P = 0.039). At 30 min, the value in subgroup D was also significantly different from those in subgroups A and C(D vs C: t = 6.325, P = 0.000; D vs A: t = 5.912, P = 0.000). The mean DOB values of subjects with Billroth Ⅰ anastomosis were higher than those of subjects with Billroth Ⅱ anastomosis irrespectively of the detection time and posture(P > 0.05).CONCLUSION: Utilization of the left lateral recumbent position during the procedure and when collecting the last breath sample may improve the diagnostic accuracy of the 13C-UBT in partial gastrectomy patients.展开更多
A capsulated microdose 14C-urea breath test (14C-UBT) was developed to detect Helicobacter pylori (HP) infection in 137 patients (54 HP negative and 83 HP positive individuals)to whom a single dose of 3. 7x 104 Bq of...A capsulated microdose 14C-urea breath test (14C-UBT) was developed to detect Helicobacter pylori (HP) infection in 137 patients (54 HP negative and 83 HP positive individuals)to whom a single dose of 3. 7x 104 Bq of 14C-urea in a capsule was given. Samples of exhaled gas were collected at the sib, 10th, 15th. 20th, 25th, 30th, 45th and 60th minute after the administration and the peak value of exhaled 14CO2 was found in the samples collected at the 25th minute. This peak value was taken as the measuring point and directly expressed as Bq/mmol CO2 to develop a new detecting method. Then its results were compared with those of HP culture and histological examination. It was found that the samples collected on the 25th minute showed a sensitivity of 97. 06%, specificity of 95. 12%, positive predictive value of 97. 06% and negative predictive value of 95. 12% respectively when the mean value of 14CO2 in HP negative subjects ±3s on the 25th minute was taken as the critical value. This suggests that the capsule-based microdose 14C-UBT may replace conventional 14C-UBT using a larger dose of (1. 85-3. 7)x 105 Bq for it is non-invasive, safe, rapid, accurate, simple and economic.展开更多
AIM: TO evaluate the accuracy of two non-invasive tests in a population of Alaska Native persons. High rates of Helicobacter pylori (H. pylon] infection, H. pyIori treatment failure, and gastric cancer in this popul...AIM: TO evaluate the accuracy of two non-invasive tests in a population of Alaska Native persons. High rates of Helicobacter pylori (H. pylon] infection, H. pyIori treatment failure, and gastric cancer in this population necessitate documentation of infection status at multiple time points over a patient's life.urease test, 13C urea breath test (UBT), and immunoglobulin G antibodies to H. pylori in serum. The performances of 13C-UBT and antibody test were compared to a gold standard defined by a positive H. pylori test by culture or, in case of a negative culture result, by positive histology and a positive rapid urease test.RESULTS: The sensitivity and specificity of the 13C- UBT were 93% and 88%, respectively, relative to the gold standard. The antibody test had an equivalent sensitivity of 93% with a reduced specificity of 68%. The false positive results for the antibody test were associated with previous treatment for an H. pylorlinfection [relative risk (RR) = 2.8]. High levels of antibodies to H. py/or/were associated with chronic gastritis and male gender, while high scores in the 13C-UBT test were associated with older age and with theH. pylori bacteria load on histological examination (RR = 4.4). CONCLUSION: The 13C-UBT outperformed the antibody test for H. pylori and could be used when a noninvasive test is clinically necessary to document treatment outcome or when monitoring for reinfection.展开更多
AIM: To investigate the effects of proton pump inhibitor (PPI) treatment on stool antigen test using the TestMate pylori enzyme immunoassay. METHODS: This study assessed 28 patients [16 men and 12 women; mean age (63....AIM: To investigate the effects of proton pump inhibitor (PPI) treatment on stool antigen test using the TestMate pylori enzyme immunoassay. METHODS: This study assessed 28 patients [16 men and 12 women; mean age (63.1 ± 5.9) years; range, 25-84 years] who underwent stool antigen test and urea breath test (UBT) before and after PPI administration. RESULTS: Using the UBT as the standard, the sensitivity, specif icity and agreement of the stool antigen test in all 28 patients were 95.2%, 71.4%, and 89.3%, respectively, before PPI administration, and 88.9%, 90.9%, and 89.3%, respectively, after PPI treatment. Mean UBT values were 23.98% ± 5.33% before and 16.19% ± 4.75% after PPI treatment and, in 15 patients treated for ≥ 4 wk, were signif icantly lower after than before 4 wk of PPI treatment (12.58% ± 4.49% vs 24.53% ± 8.53%, P = 0.048). The mean optical density (A450/630) ratios on the stool antigen test were 1.16 ± 0.20 before and 1.17 ± 0.24 after PPI treatment (P = 0.989), and were 1.02 ± 0.26 and 0.69 ± 0.28, respectively, in the group treated for > 4 wk (P = 0.099).展开更多
Proper diagnosis in the pediatric population is required to eradicate Helicobacter pylori (H. pylori) and prevent gastric cancer. Our aim was to assess the performance of non-invasive tests to diagnose H. pylori infec...Proper diagnosis in the pediatric population is required to eradicate Helicobacter pylori (H. pylori) and prevent gastric cancer. Our aim was to assess the performance of non-invasive tests to diagnose H. pylori infection in pediatric patients. A retrospective analysis was performed on 141 pediatric patients requiring endoscopic evaluation and diagnostic tests for H. pylori infection to define the cause of abdominal symptoms. Non-invasive tests included the 13C-urea breath test (UBT), a monoclonal stool antigen test using enzyme-linked immuno-sorbent assay (mSAT), and a serum immunoglobulin G antibody test using antigens derived from Japanese individuals (S-Ab). This study investigated sensitivity, specificity, likelihood ratios for a positive and a negative test (LR+ and LR-), and accuracy of non-invasive tests, in comparison with invasive tests. Eighty two of 141 patients (58%) were recognized as H. pylori positive by invasive methods. When UBT, mSAT or S-Ab were analyzed, all were found to be effective over 94% accurate. Specificity ranged between 86.7% and 95.8%, and sensitivity ranged between 93.8% and 97.1%. When subjects were stratified into three distinct age groups, the best performance was achieved for 1-6 years old with mSAT at 100% for sensitivity, specificity, and accuracy. S-Ab yielded the best results for children 7-12 years old and the UBT test performed best for 13-18 years old. These results demonstrate the utility of UBT, mSAT, and S-Ab non-invasive tests in diagnosing H. pylori but suggest that certain tests may be optimal for children of distinct ages. Three non-invasive tests, UBT, mSAT and S-Ab showed sufficient sensitivity, specificity and accuracy for the initial diagnosis of H. pylori infection among pediatric patients. Non-invasive tests may contribute to achieving minimum invasive diagnosis with combining with a histological test and a culture test in children.展开更多
BACKGROUND^(14)C urea breath test(^(14)C UBT)and immunohistochemical staining(IHC)are widely used for detection Helicobacter pylori(H.pylori)infection with different sensitivity,and there is a difference in H.pylori i...BACKGROUND^(14)C urea breath test(^(14)C UBT)and immunohistochemical staining(IHC)are widely used for detection Helicobacter pylori(H.pylori)infection with different sensitivity,and there is a difference in H.pylori infection rate in Uyghur and Han ethnic groups.Both need large cohort studies to evaluate the differences more accurately.AIM To analyze the difference between^(14)C UBT and IHC for H.pylori detection in Xinjiang Uyghur Autonomous Region and the difference between Uyghur and Han populations.METHODS There were 3944 cases of H.pylori infection detected by both IHC and^(14)C UBT at the same time(interval<1 wk,with sampling site including gastric antrum,selected from 5747 patients).We compared the sensitivity of^(14)C UBT and IHC.We also compared 555 pairs of Han/Uyghur cases(completely matched for gender and age)for their H.pylori infection rates.The overall H.pylori infection rate of all 5747 cases and the correlation with other clinicopathological data were also further analyzed.SPSS V23.0 software was used for statistical analysis.RESULTS The sensitivity was 94.9%for^(14)C UBT and 65.1%for IHC,which was a significant difference(n=3944,P<0.001).However,among those cases negative for H.pylori by^(14)C UBT(detection value≤100),4.8%were positive by IHC.Combining both methods,the overall H.pylori infection rate was 48.6%(n=5747),and differences in gender,age group,ethnicity and region of residence significantly affected the H.pylori positive rates.According to age group(Han/Uyghur),the positive rates were≤30 years(62.2%/100.0%),31-40 years(45.2%/85.7%),41-50 years(47.2%/79.2%),51-60 years(44.6%/76.1%),61-70 years(40.9%/68.2%),71-80 years(41.7%/54.1%)and≥81 years(42.9%/NA).The H.pylori infection rates of Han/Uyghur paired cases were 41.4%and 73.3%,which was a significant difference(P<0.001)(555 pairs).H.pylori positivity was significantly related to moderate-severe grade 2-3 chronic/active gastritis and intestinal metaplasia(all P<0.05).CONCLUSION The sensitivity of^(14)C UBT was significantly higher,but combined application can still increase the accuracy.The prevention H.pylori should be emphasized for Uygur and young people.展开更多
基金Supported by Scientific Initiation Scholarship Programme(PIBIC)of the Bahia State Research Support Foundationthe Doctorate Scholarship Program of the Coordination of Improvement of Higher Education Personnel+1 种基金the Scientific Initiation Scholarship Programme(PIBIC)of the National Council for Scientific and Technological Developmentand the CNPq Research Productivity Fellowship.
文摘BACKGROUND Helicobacter pylori(H.pylori)infection has been well-established as a significant risk factor for several gastrointestinal disorders.The urea breath test(UBT)has emerged as a leading non-invasive method for detecting H.pylori.Despite numerous studies confirming its substantial accuracy,the reliability of UBT results is often compromised by inherent limitations.These findings underscore the need for a rigorous statistical synthesis to clarify and reconcile the diagnostic accuracy of the UBT for the diagnosis of H.pylori infection.AIM To determine and compare the diagnostic accuracy of 13C-UBT and 14C-UBT for H.pylori infection in adult patients with dyspepsia.METHODS We conducted an independent search of the PubMed/MEDLINE,EMBASE,and Cochrane Central databases until April 2022.Our search included diagnostic accuracy studies that evaluated at least one of the index tests(^(13)C-UBT or ^(14)C-UBT)against a reference standard.We used the QUADAS-2 tool to assess the methodo-logical quality of the studies.We utilized the bivariate random-effects model to calculate sensitivity,specificity,positive and negative test likelihood ratios(LR+and LR-),as well as the diagnostic odds ratio(DOR),and their 95%confidence intervals.We conducted subgroup analyses based on urea dosing,time after urea administration,and assessment technique.To investigate a possible threshold effect,we conducted Spearman correlation analysis,and we generated summary receiver operating characteristic(SROC)curves to assess heterogeneity.Finally,we visually inspected a funnel plot and used Egger’s test to evaluate publication bias.endorsing both as reliable diagnostic tools in clinical practice.CONCLUSION In summary,our study has demonstrated that ^(13)C-UBT has been found to outperform the ^(14)C-UBT,making it the preferred diagnostic approach.Additionally,our results emphasize the significance of carefully considering urea dosage,assessment timing,and measurement techniques for both tests to enhance diagnostic precision.Nevertheless,it is crucial for researchers and clinicians to evaluate the strengths and limitations of our findings before implementing them in practice.
文摘In this editorial,we discuss the article in the World Journal of Gastroenterology.The article conducts a meta-analysis of the diagnostic accuracy of the urea breath test(UBT),a non-invasive method for detecting Helicobacter pylori(H.pylori)infection in humans.It is based on radionuclide-labeled urea.Various methods,both invasive and non-invasive,are available for diagnosing H.pylori infection,inclu-ding endoscopy with biopsy,serology for immunoglobulin titers,stool antigen analysis,and UBT.Several guidelines recommend UBTs as the primary choice for diagnosing H.pylori infection and for reexamining after eradication therapy.It is used to be the first choice non-invasive test due to their high accuracy,specificity,rapid results,and simplicity.Moreover,its performance remains unaffected by the distribution of H.pylori in the stomach,allowing a high flow of patients to be tested.Despite its widespread use,the performance characteristics of UBT have been inconsistently described and remain incompletely defined.There are two UBTs available with Food and Drug Administration approval:The 13C and 14C tests.Both tests are affordable and can provide real-time results.Physicians may prefer the 13C test because it is non-radioactive,compared to 14C which uses a radioactive isotope,especially in young children and pregnant women.Although there was heterogeneity among the studies regarding the diagnostic accuracy of both UBTs,13C-UBT consistently outperforms the 14C-UBT.This makes the 13C-UBT the preferred diagnostic approach.Furthermore,the provided findings of the meta-analysis emphasize the significance of precise considerations when choosing urea dosage,assessment timing,and measurement techniques for both the 13C-UBT and 14C-UBT,to enhance diagnostic precision.
基金University Research Council Grant, No. 041F431YC
文摘AIM: To validate and compare the cost of microdose ^14C urea breath test (UBT) with histology and rapid urease test for the diagnosis of H Py/ori. METHODS: Ninety-four consecutive patients with dyspeptic symptoms undergoing gastroscopy were enrolled. Gastric biopsies were taken for histology and rapid urease test. UBT was performed after gastroscopy by microdose ^14 urea capsules. Sensitivity, specificity and accuracy of UBT were calculated and compared with histology and rapid urease test. Cost comparison of these tests was also performed. RESULTS: H pylori was diagnosed by histology and rapid urease test in 66 (70%) and 61 (65%) patients, while ^14C UBT detected infection in 63 (67%). Accuracy of UBT was 93% in comparison with histology while its positive and negative predictive values were 97% and 84%, respectively. Comparison of ^14C UBT with rapid urease test gives an accuracy of 96%, with positive and negative predictive values of 95% and 97%, respectively. These results were highly reproducible with a Kappa test (P value 〈 0.001). Cost of histology or rapid urease test with gastroscopy was 110 USD or 95 USD respectively while the cost of UBT was 15 USD.CONCLUSION: Microdose ^14C UBT was comparable to histology and rapid urease test. ^14C UBT is an economical, self sufficient and suitable test to diagnose active Hpylori infection in less developed countries.
文摘AIM To determine the sensitivity and specificity of the ^(13)C-urea breath test(UBT) in patients taking proton pump inhibitors(PPIs), using a new test meal Refex. METHODS One hundred and fourteen consecutive patients with dyspepsia, 53 Helicobacter pylori(H. pylori) positive, 49 H. pylori negative, were included in the study. The patients were then given esomeprazole 40 mg for 29 consecutive days, and the ^(13)C-UBT with the new test meal was performed the next morning. RESULTS The sensitivity of the ^(13)C-UBT with a cut off 2.5‰ was92.45%(95%CI: 81.79%-97.91%) by per-protocol(PP) analysis and 78.13 %(95%CI: 66.03%-87.49%) by intention-to-treat(ITT) analysis. The specificity of the ^(13)C-UBT test was 96.00 % in the ITT population(95%CI: 86.29%-99.51%) and 97.96% in the PP population(95%CI: 89.15%-99.95%).CONCLUSION The new test meal based ^(13)C-UBT is highly accurate in patients on PPIs and can be used in those unable to stop their PPI treatment.
文摘AIM: Urea breath test (UBT) is a non-invasive diagnostic test for detecting the presence of Helicobacter pylori(H pylori).In this study we evaluated the effect of anti-tuberculosis therapy on the results of 14C-UBT.METHODS: Patients, with the diagnosis of tuberculosis (TB) who had a positive UBT at the point of starting antiTB therapy, were included. None had a history of peptic ulcer disease or had taken antibiotics, bismuth compounds and/or PPI in the previous month, 14C-UBT was repeated at the end of the second month and the end of treatment period and one month after completion of treatment course.RESULTS: Thirty-five patients (23 males) were enrolled.14C-UBT was negative in all 35 patients (100%) at the end of the second month and remained negative in 30cases (85.7%) at the end of the treatment course. One month after completion of treatment course, UBT remained negative in 13 patients (37.1%).CONCLUSION: Our report underscores the need for caution while interpreting urea breath test results in patients undergoing anti-TB therapy. Furthermore, the combination of drugs used in this study resulted in H pylori eradication in a minority of patients.
文摘AIM: To evaluate the agreement between a mAb-based stool test (HP STAR) and the urea breath test (UBT) in monitoring (H pylon) infection after eradication therapy. METHODS: Patients with discordant results on UBT and Hp STAR underwent endoscopy with biopsies for rapid urease test, culture, and histology to confirm H pylori status. RESULTS: Among 250 patients (50±14 years), 240 (96.0%) had concordant UBT and Hp STAR tests with a significant correlation between DOB and A values (R = 0.87; P〈0.0001). The remaining 10 (4.0%) patients had discordant tests (positive Hp STAR and negative UBT) with the Hp STAR inaccurate in five cases (false positive) and UBT inaccurate in the other five cases (false negative). The “maximal expected” sensitivity, specificity, +PV, -PV, +LR, and -LR were 91%, 100%, 100%, 97.4%, ∞, and 8.2 respectively, for the UBT, and 100%, 97.4%, 91%, 100%, 38.8, and 0, respectively, for the Hp STAR. Overall accuracy for both tests was 98%. CONCLUSION: Both the UBT and the Hp StAR are equally accurate in monitoring H pylori infection. Nowadays, the choice of the “best” non-invasive H pylori test in the post-treatment setting should be done not only in terms of diagnostic accuracy but also in view of cost and local facilities.
基金Supported by A grant from the National Hospital Organization,No. H21-NHO-01
文摘We evaluated the efficacy and tolerability of a dual therapy with rabeprazole and amoxicillin (AMX) as an empiric third-line rescue therapy. In patients with failure of first-line treatment with a proton pump inhibitor (PPI)- AMX-clarithromycin regimen and second-line treatment with the PPI-AMX-metronidazole regimen, a third-line eradication regimen with rabeprazole (10 mg q.i.d.) and AMX (500 mg q.i.d.) was prescribed for 2 wk. Eradication was confirmed by the results of the 13C-urea breath test (UBT) at 12 wk after the therapy. A total of 46 patients were included; however, two were lost to followup. The eradication rates as determined by per-protocol and intention-to-treat analyses were 65.9% and 63.0%,respectively. The pretreatment UBT results in the subjects showing eradication failure; those patients showing successful eradication comprised 32.9 ± 28.8 permil and 14.8 ± 12.8 permil, respectively. The pretreatment UBT results in the subjects with eradication failure were significantly higher than those in the patients with successful eradication (P = 0.019). A low pretreatment UBT result (≤ 28.5 permil) predicted the success of the eradication therapy with a positive predictive value of 81.3% and a sensitivity of 89.7%. Adverse effects were reported in 18.2% of the patients, mainly diarrhea and stomatitis. Dual therapy with rabeprazole and AMX appears to serve as a potential empirical third-line strategy for patients with low values on pretreatment UBT.
文摘AIM: To quantitatively summarize and appraise the available evidence of urea breath test(UBT) use to diagnose Helicobacter pylori(H. pylori) infection in patients with dyspepsia and provide pooled diagnostic accuracy measures.METHODS: We searched MEDLINE, EMBASE, Cochrane library and other databases for studies addressing the value of UBT in the diagnosis of H. pylori infection. We included cross-sectional studies that evaluated the diagnostic accuracy of UBT in adult patients with dyspeptic symptoms. Risk of bias was assessed using QUADAS(Quality Assessment of Diagnostic Accuracy Studies)-2 tool. Diagnostic accuracy measures were pooled using the random-effects model. Subgroup analysis was conducted by UBT type(13C vs 14C) and by measurement technique(Infrared spectrometry vs Isotope Ratio Mass Spectrometry).RESULTS: Out of 1380 studies identified, only 23 met the eligibility criteria. Fourteen studies(61%) evaluated 13 C UBT and 9 studies(39%) evaluated 14 C UBT. There was significant variation in the type of reference standard tests used across studies.Pooled sensitivity was 0.96(95%CI: 0.95-0.97) andpooled specificity was 0.93(95%CI: 0.91-0.94). Likelihood ratio for a positive test was 12 and for a negative test was 0.05 with an area under thecurve of 0.985. Meta-analyses were associated with a significant statistical heterogeneity that remained unexplained after subgroup analysis. The included studies had a moderate risk of bias.CONCLUSION: UBT has high diagnostic accuracy for detecting H. pylori infection in patients with dyspepsia. The reliability of diagnostic meta-analytic estimates however is limited by significant heterogeneity.
文摘AIM: To verify whether there is a gender difference in the 13C-urea breath test results in a large cohort. METHODS: The test results of dyspeptic patients referred for 13C-urea breath testing between January and December, 2007 were evaluated. Testing was carried out at the health insurance organization branches and evaluated at a central laboratory in Israel. RESULTS: Of a total of 28 746 test results, 18 122 (63.04%) were from females and 10 624 (36.95%) from males. Overall, 10 188 (35.4%) results [expressed as delta over baseline (DOB)] were positive (DOB 13C > 5), 18,326 (63.7%) were negative (DOB 13C < 3.5) and 232 (0.8%) were borderline (DOB 13C 3.5-5). There was a significant difference between the total positive rate among females and males (34.8% vs 37.2%, respectively, P = 0.0003). The mean test value was increased by approximately 10 units for females compared to males (P < 0.01) and this difference was consistent for all age groups (i.e., between 10-80 years of age, P < 0.01). CONCLUSION: More females were referred to 13C-urea breath testing. More males had positive results. The mean test values were significantly higher among females of all age groups, possibly representing an increased bacterial load among females and suggesting gender-associated differences in Helicobacter pylori host interactions.
基金Supported by The Guidance Project of Science and Technology Commission of Shanghai MunicipalityNo.134119a1700+5 种基金the Appropriate Project of Shanghai Municipal Health BureauNo.2013SY049Shanghai Key Laboratory of Clinical Geriatric MedicineNo.13DZ2260700the Scientific Research Projects of Shanghai Municipal Health BureauNo.20134377
文摘AIM: To investigate whether posture affects the accuracy of 13C-urea breath test(13C-UBT) for Helicobacter pylori(H. pylori) detection in partial gastrectomy patients. METHODS: We studied 156 consecutive residual stomach patients, including 76 with H. pylori infection(infection group) and 80 without H. pylori infection(control group). H. pylori infection was confirmed if both the rapid urease test and histology were positive during gastroscopy. The two groups were divided into four subgroups according to patients' posture during the 13C-UBT: subgroup A, sitting position; subgroup B, supine position; subgroup C, right lateral recumbent position; and subgroup D, left lateral recumbent position. Each subject underwent the following modified 13C-UBT: 75 mg of 13C-urea(powder) in 100 m L of citric acid solution was administered, and a mouth wash was performed immediately; breath samples were then collected at baseline and at 5-min intervals up to 30 min while the position was maintained. Seven breathsamples were collected for each subject. The cutoff value was 2.0‰.RESULTS: The mean delta over baseline(DOB) values in the subgroups of the infection group were similar at 5 min(P > 0.05) and significantly higher than those in the corresponding control subgroups at all time points(P < 0.01). In the infection group, the mean DOB values in subgroup A were higher than those in other subgroups within 10 min and peaked at the 10-min point(12.4‰± 2.4‰). The values in subgroups B and C both reached their peaks at 15 min(B, 13.9‰± 1.5‰; C, 12.2‰± 1.7‰) and then decreased gradually until the 30-min point. In subgroup D, the value peaked at 20 min(14.7‰± 1.7‰). Significant differences were found between the values in subgroups D and B at both 25 min(t = 2.093, P = 0.043) and 30 min(t = 2.141, P = 0.039). At 30 min, the value in subgroup D was also significantly different from those in subgroups A and C(D vs C: t = 6.325, P = 0.000; D vs A: t = 5.912, P = 0.000). The mean DOB values of subjects with Billroth Ⅰ anastomosis were higher than those of subjects with Billroth Ⅱ anastomosis irrespectively of the detection time and posture(P > 0.05).CONCLUSION: Utilization of the left lateral recumbent position during the procedure and when collecting the last breath sample may improve the diagnostic accuracy of the 13C-UBT in partial gastrectomy patients.
文摘A capsulated microdose 14C-urea breath test (14C-UBT) was developed to detect Helicobacter pylori (HP) infection in 137 patients (54 HP negative and 83 HP positive individuals)to whom a single dose of 3. 7x 104 Bq of 14C-urea in a capsule was given. Samples of exhaled gas were collected at the sib, 10th, 15th. 20th, 25th, 30th, 45th and 60th minute after the administration and the peak value of exhaled 14CO2 was found in the samples collected at the 25th minute. This peak value was taken as the measuring point and directly expressed as Bq/mmol CO2 to develop a new detecting method. Then its results were compared with those of HP culture and histological examination. It was found that the samples collected on the 25th minute showed a sensitivity of 97. 06%, specificity of 95. 12%, positive predictive value of 97. 06% and negative predictive value of 95. 12% respectively when the mean value of 14CO2 in HP negative subjects ±3s on the 25th minute was taken as the critical value. This suggests that the capsule-based microdose 14C-UBT may replace conventional 14C-UBT using a larger dose of (1. 85-3. 7)x 105 Bq for it is non-invasive, safe, rapid, accurate, simple and economic.
基金Supported by The Centers for Disease Control and Prevention13C urea breath tests were provided by Meretek Diagnostics Inc.,Lafayette,CO,United States
文摘AIM: TO evaluate the accuracy of two non-invasive tests in a population of Alaska Native persons. High rates of Helicobacter pylori (H. pylon] infection, H. pyIori treatment failure, and gastric cancer in this population necessitate documentation of infection status at multiple time points over a patient's life.urease test, 13C urea breath test (UBT), and immunoglobulin G antibodies to H. pylori in serum. The performances of 13C-UBT and antibody test were compared to a gold standard defined by a positive H. pylori test by culture or, in case of a negative culture result, by positive histology and a positive rapid urease test.RESULTS: The sensitivity and specificity of the 13C- UBT were 93% and 88%, respectively, relative to the gold standard. The antibody test had an equivalent sensitivity of 93% with a reduced specificity of 68%. The false positive results for the antibody test were associated with previous treatment for an H. pylorlinfection [relative risk (RR) = 2.8]. High levels of antibodies to H. py/or/were associated with chronic gastritis and male gender, while high scores in the 13C-UBT test were associated with older age and with theH. pylori bacteria load on histological examination (RR = 4.4). CONCLUSION: The 13C-UBT outperformed the antibody test for H. pylori and could be used when a noninvasive test is clinically necessary to document treatment outcome or when monitoring for reinfection.
文摘AIM: To investigate the effects of proton pump inhibitor (PPI) treatment on stool antigen test using the TestMate pylori enzyme immunoassay. METHODS: This study assessed 28 patients [16 men and 12 women; mean age (63.1 ± 5.9) years; range, 25-84 years] who underwent stool antigen test and urea breath test (UBT) before and after PPI administration. RESULTS: Using the UBT as the standard, the sensitivity, specif icity and agreement of the stool antigen test in all 28 patients were 95.2%, 71.4%, and 89.3%, respectively, before PPI administration, and 88.9%, 90.9%, and 89.3%, respectively, after PPI treatment. Mean UBT values were 23.98% ± 5.33% before and 16.19% ± 4.75% after PPI treatment and, in 15 patients treated for ≥ 4 wk, were signif icantly lower after than before 4 wk of PPI treatment (12.58% ± 4.49% vs 24.53% ± 8.53%, P = 0.048). The mean optical density (A450/630) ratios on the stool antigen test were 1.16 ± 0.20 before and 1.17 ± 0.24 after PPI treatment (P = 0.989), and were 1.02 ± 0.26 and 0.69 ± 0.28, respectively, in the group treated for > 4 wk (P = 0.099).
文摘Proper diagnosis in the pediatric population is required to eradicate Helicobacter pylori (H. pylori) and prevent gastric cancer. Our aim was to assess the performance of non-invasive tests to diagnose H. pylori infection in pediatric patients. A retrospective analysis was performed on 141 pediatric patients requiring endoscopic evaluation and diagnostic tests for H. pylori infection to define the cause of abdominal symptoms. Non-invasive tests included the 13C-urea breath test (UBT), a monoclonal stool antigen test using enzyme-linked immuno-sorbent assay (mSAT), and a serum immunoglobulin G antibody test using antigens derived from Japanese individuals (S-Ab). This study investigated sensitivity, specificity, likelihood ratios for a positive and a negative test (LR+ and LR-), and accuracy of non-invasive tests, in comparison with invasive tests. Eighty two of 141 patients (58%) were recognized as H. pylori positive by invasive methods. When UBT, mSAT or S-Ab were analyzed, all were found to be effective over 94% accurate. Specificity ranged between 86.7% and 95.8%, and sensitivity ranged between 93.8% and 97.1%. When subjects were stratified into three distinct age groups, the best performance was achieved for 1-6 years old with mSAT at 100% for sensitivity, specificity, and accuracy. S-Ab yielded the best results for children 7-12 years old and the UBT test performed best for 13-18 years old. These results demonstrate the utility of UBT, mSAT, and S-Ab non-invasive tests in diagnosing H. pylori but suggest that certain tests may be optimal for children of distinct ages. Three non-invasive tests, UBT, mSAT and S-Ab showed sufficient sensitivity, specificity and accuracy for the initial diagnosis of H. pylori infection among pediatric patients. Non-invasive tests may contribute to achieving minimum invasive diagnosis with combining with a histological test and a culture test in children.
文摘BACKGROUND^(14)C urea breath test(^(14)C UBT)and immunohistochemical staining(IHC)are widely used for detection Helicobacter pylori(H.pylori)infection with different sensitivity,and there is a difference in H.pylori infection rate in Uyghur and Han ethnic groups.Both need large cohort studies to evaluate the differences more accurately.AIM To analyze the difference between^(14)C UBT and IHC for H.pylori detection in Xinjiang Uyghur Autonomous Region and the difference between Uyghur and Han populations.METHODS There were 3944 cases of H.pylori infection detected by both IHC and^(14)C UBT at the same time(interval<1 wk,with sampling site including gastric antrum,selected from 5747 patients).We compared the sensitivity of^(14)C UBT and IHC.We also compared 555 pairs of Han/Uyghur cases(completely matched for gender and age)for their H.pylori infection rates.The overall H.pylori infection rate of all 5747 cases and the correlation with other clinicopathological data were also further analyzed.SPSS V23.0 software was used for statistical analysis.RESULTS The sensitivity was 94.9%for^(14)C UBT and 65.1%for IHC,which was a significant difference(n=3944,P<0.001).However,among those cases negative for H.pylori by^(14)C UBT(detection value≤100),4.8%were positive by IHC.Combining both methods,the overall H.pylori infection rate was 48.6%(n=5747),and differences in gender,age group,ethnicity and region of residence significantly affected the H.pylori positive rates.According to age group(Han/Uyghur),the positive rates were≤30 years(62.2%/100.0%),31-40 years(45.2%/85.7%),41-50 years(47.2%/79.2%),51-60 years(44.6%/76.1%),61-70 years(40.9%/68.2%),71-80 years(41.7%/54.1%)and≥81 years(42.9%/NA).The H.pylori infection rates of Han/Uyghur paired cases were 41.4%and 73.3%,which was a significant difference(P<0.001)(555 pairs).H.pylori positivity was significantly related to moderate-severe grade 2-3 chronic/active gastritis and intestinal metaplasia(all P<0.05).CONCLUSION The sensitivity of^(14)C UBT was significantly higher,but combined application can still increase the accuracy.The prevention H.pylori should be emphasized for Uygur and young people.