14C]-urea breath test to confirm eradication of Helicobacter pylori

BACKGROUND: Treatment for Helicobacter pylori reduces ulcer recurrence. Eradication rates of the organism vary with different drug regimens from 30% to 90%. There is a need to identify patients who have failed treatment. [14C]-Urea breath test (UBT) is non-invasive, sensitive, safe and highly reliable test for diagnosis of H. pylori infection. As there is a paucity of reports on the utility of [14C]-UBT in confirming H. pylori eradication, this study was undertaken. METHODS: Thirty-eight patients (age 34 +/- 17 years, range 16-84 years, 27 men) with upper gastrointestinal symptoms underwent upper gastrointestinal endoscopy. Baseline H. pylori infection was diagnosed by identification of the organism on antral biopsies and positive rapid urease test (RUT). After 1 month of completion of treatment, repeat RUT and histological examination of antral endoscopic biopsies were performed. Eradication of H. pylori was defined as absence of the organism on histology, and negative RUT. The [14C]-UBT was performed using 185 kBq [14C]-urea dissolved in 300 mL water. Breath samples were collected once before ingestion of [14C]-urea, and subsequently at 5 and 15 min. Results were expressed as 14CO2/mmol CO2 exhaled as per cent of administered urea. RESULTS: Endoscopy revealed antral gastritis (n = 14), duodenal ulcer (n = 8), duodenitis (n = 2), oesophagitis (n = 1), antral gastritis and duodenal ulcer (n = 3), antral gastritis and duodenitis (n = 7) and normal upper gastrointestinal endoscopy (n = 3). All the 20 patients who were negative for H. pylori on RUT and histology, tested negative for H. pylori on [14C]-UBT. However, of 18 patients shown to have H. pylori infection on RUT and histology, 16 were positive for H. pylori on [14C]-UBT. The sensitivity, specificity, positive predictive value, negative predictive value and accuracy of [14C]-UBT were 100, 89, 91, 100 and 95% respectively. CONCLUSIONS: The [14C]-UBT is a reliable indicator of H. pylori eradication after treatment. It can obviate the need for antral biopsies to confirm eradication of H. pylori after completion of treatment.     

Helicobacter pylori antigen stool test and 13C-urea breath test in patients after eradication treatments

OBJECTIVES: Current guidelines recommend either the urea breath test (UBT) or the Helicobacter pylori antigen stool test (HpSA) for monitoring H. pylori infection. The aim of this study was to evaluate the agreement between the two tests in patients after treatment. METHODS: After eradication treatments, patients were tested with both UBT and HpSA. Cut-off values (delta value over baseline at 30') for UBT were positive (> or = 5 per thousand), indeterminate (3.01-4.99 per thousand), and negative (< or = 3 per thousand). Cut-off values (absorbance at 450 nm) for HpSA test were positive (> or = 0.160), indeterminate (0.159-0.140), and negative (< 0.140). Patients with either discordant or indeterminate tests underwent repeat endoscopy with multiple gastric biopsies for rapid urease test (RUT), culture, histology, and immunohistochemistry to detect H. pylori and to assess the ratio between coccoid and bacillary forms. RESULTS: A total of 458 patients were studied. Of these, 422 (92.2%) had concordant tests, three (0.6%) indeterminate tests (one on UBT and two on HpSA), and 33 (7.2%) discordant tests. A total of 28 patients (25 with discordant and three with indeterminate tests) underwent endoscopy. The HpSA was inaccurate in 24 cases (18 false negative, four false positive, and two indeterminate results), whereas the UBT was inaccurate in four cases (two false positive, one false negative, and one indeterminate results). Biopsy-based tests showed no bacillary or coccoid forms in all five endoscoped patients who were negative on UBT and positive on HpSA, but in one in whom the ratio between coccoid and bacillary forms was 3:1 in the antrum and corpus. CONCLUSIONS: UBT and HpSA test give discordant or indeterminate results in nearly 8% of patients after treatment. The HpSA test is less accurate than the UBT. Coccoid forms do not cause false positive HpSA results.     

Accurate diagnosis of Helicobacter pylori. 13C-urea breath test

The preferred schema for management of Helicobacter pylori infection is diagnosis, treatment, and confirmation of cure. The 13C-urea breath test is ideal for active H. pylori infection for those in whom endoscopy is not required (e.g., those in whom cancer is not suspected) because it offers the combination of simplicity, accuracy, reliability, and absence of exposure to radioactivity. New versions of the test also offer increasing simplicity and lower costs.     

Appropriate cut-off value of 13C-urea breath test after eradication of Helicobacter pylori infection in Japan

BACKGROUND AND AIM: A cut-off value of 2.5 per thousand for the 13C-urea breath test (UBT) is recommended in Japanese persons, based on the result of a multicenter trial in patients prior to treatment for eradication of Helicobacter pylori. The cut-off value of 2.5 per thousand has also been used in the assessment of eradication after treatment. The 6-8-week evaluation after treatment is recommended in the guidelines of the Japanese Society of Gastroenterology. The present study aimed to prospectively re-assess the cut-off value of the 13C-UBT at 6 weeks after treatment by using the results obtained at 6 months as an indication of true positive or true negative H. pylori infection status. METHODS: One hundred and ninety patients who were positive for H. pylori underwent eradication treatment, and 177 patients of these patients who were assessed as having true positive or true negative H. pylori status at 6 months after treatment were evaluated in this study. Eradication was assessed by 13C-UBT, culture, and histology at 6 weeks and at 6 months after treatment, and the cut-off value of 13C-UBT at 6 weeks was re-assessed. RESULTS: A cut-off value of 3.5 per thousand. at 6 weeks after treatment showed 97.2% diagnostic accuracy, while a cut-off value of 2.5 per thousand at 6 weeks showed 96.0% diagnostic accuracy. For a 3.5 per thousand cut-off value, only five patients were positive by 13C-UBT and were negative by culture and histology at 6 weeks, and three patients were true positive and two were false positive by the 13C-UBT at 6 months. CONCLUSION: A cut-off value of 3.5 per thousand for the 13C-UBT is recommended at 6 weeks after eradication treatment in Japanese persons.     

Appropriate timing of the 14C-urea breath test to establish eradication of Helicobacter pylori infection

OBJECTIVE: The aim of this study was to determine the performance characteristics of the 14C-urea breath test (UBT) performed 2 wk after the completion of therapy for Helicobacter pylori using a 4 to 6 wk study as the gold standard. METHODS: Patients with active Helicobacter pylori infection at four medical centers received proton pump inhibitor-based triple or quadruple therapy for 10-14 days. Patients underwent the 14C-UBT 2 and 4-6 wk after the completion of therapy. A positive test was defined as 14CO2 excretion of >200 dpm, a negative test as <50 dpm, and an equivocal test as >50 but <200 dpm. Performance characteristics of the 2-wk UBT were calculated using the 4 to 6-wk result as a gold standard. RESULTS: Eighty-five patients were enrolled and 82 patients (mean +/- SD age, 62 +/- 15 yr; 15 women) completed the protocol. Four patients had equivocal UBT results and were excluded from the analysis. Of the 78 patients, 68 (87%) had a negative 4 to 6-wk UBT. The 2-week UBT yielded a sensitivity of 90% (95% confidence interval 72-100%), specificity of 99% (97-100%), and accuracy of 97% (93-100%). In patients with a persistently positive UBT, 14CO2 excretion at 2 wk was significantly lower than at 4-6 wk after therapy (p = 0.03). CONCLUSIONS: A UBT performed 2 wk after therapy yielded results comparable to 4 to 6 wk testing. Further studies to evaluate the optimal time of confirmatory testing in the age of more effective proton pump inhibitor-based triple therapies are warranted.     

Effect of Helicobacter pylori on gastric emptying in non-ulcer dyspepsia--evaluation of Helicobacter pylori by 13C-urea breath test]

AIM: Non-ulcer dyspepsia (NUD) is a common disorder in clinical field. The pathogenesis of NUD are still unclear especially the participation of Helicobacter pylori (H. pylori) in NUD is controversy. Aim of the present study was to clarify the effect of H. pylori at view of urea breath test on liquids and solids gastric emptying in patients with NUD. SUBJECTS AND METHODS: H. pylori positive (n = 24) and negative NUD subjects (n = 11), and H. pylori positive non-NUD subjects (n = 10) as control group were studied. Liquids and solids gastric emptying was evaluated according to the acetaminophen method and sulfamethzole modified method delta 13C-AUC was calculated as estimation of H. pylori by 13C-urea breath test. H. pylori positive NUD was classified into high delta 13C-AUC group (n = 11), median group (n = 8) and low group (n = 5). High delta 13C-AUC group (n = 6) and low delta 13C-AUC group (n = 4) group were treated by eradication therapy. In H. pylori positive NUD subjects, high and low delta 13C-AUC group were estimated the changes of liquids and solids gastric emptying, symptoms before and after eradication. RESULTS: H. pylori positive NUD group has higher liquids gastric emptying that H. pylori negative NUD group (7.6 +/- 2.8 vs. 4.9 +/- 1.4, p = 0.0022). No difference was observed between H. pylori positive and H. pylori negative group of solids gastric emptying. There was no significant difference in liquids gastric emptying among high-, median- and low-delta 13C-AUC group of H. pylori positive NUD subjects. Solids gastric emptying was significantly delayed in high delta 13C-AUC group compared with low delta 13C-AUC group (10.3 +/- 3.7 vs. 5.3 +/- 3.1, p = 0.014). delta 13C-AUC was not correlated to liquids gastric emptying, but to solids gastric emptying (r = -0.573. p = 0.006). In Non-NUD group as control group, delta 13C-AUC has not correlation to liquids and solids gastric emptying H. pylori positive NUD has higher delta 13C-AUC than Non-NUD group. Eradicated low delta 13C-AUC group did not show significant changes in liquids gastric emptying, but did improvement of solids gastric emptying and symptoms scores. Eradicated low delta 13C-AUC group did not show any significant changes. CONCLUSION: In non-ulcer dyspepsia patients H. pylori does not influence liquids gastric emptying, but does solids gastric emptying according to delta 13C-AUC of H. pylori, especially high delta 13C-AUC patients.     

Capsule 13C-urea breath test for the diagnosis of Helicobacter pylori infection

AIM: To compare the accuracy of capsule 13C-urea breath test (UBT) with conventional invasive methods for the diagnosis of Helicobacter pylori infection. METHODS: One hundred patients received CLO test, histological examination, culture and 100- or 50-mg capsule UBT for the diagnosis of H pylori infection. H pylori infection was defined as those with positive culture or positive results from both histology and CLO test. RESULTS: Both the sensitivity and specificity of the 100-mg capsule UBT (n=50) were 100%. The sensitivity and specificity of the 50-mg capsule UBT (n = 50) were 96.4 and 100%, respectively. Taken together, the accuracy of capsule UBT (n =100) was higher than that of CLO test, histology and culture (100% vs 92%, 91% and 89%, respectively; P= 0.035, 0.018 and 0.005, respectively). Our data showed that the optimal timing of sampling for 100-and 50-mg capsule UBT was 15-30 and 6-15 min, respectively. CONCLUSION: Capsule UBT has a higher accuracy compared with biopsy-based tests. It is an ideal method for the diagnosis of H pylori infection.     

14C-urea breath test for assessment of gastric Helicobacter pylori colonization and eradication.

BACKGROUND AND OBJECTIVE: Urea breath test (UBT) is a reliable noninvasive technique for detecting gastric Helicobacter pylori colonization. 14C isotope-based test requires simple equipment and is inexpensive. We studied the utility of 14C-UBT in diagnosis of gastric H. pylori infection. METHODS: Presence of H. pylori was studied using antral histology and culture in patients with rapid urease test (RUT)-positive peptic ulcer. 14C-UBT was performed using a 185-kBq dose. Radioactivity in 15-min breath samples was measured using a beta-scintillation counter and result expressed as % dose recovered/mmol CO2. H. pylori was considered positive when any two tests were positive. All tests were repeated one month after completion of H. pylori eradication therapy. RESULTS: Among 41 patients (duodenal ulcer 36, gastric ulcer 5), H. pylori was detected by histology in 23 (56%) and by culture in 27 (66%). Overall, H. pylori was detected in 28 (68%) patients. Follow-up assessment was possible in 28 patients: 26 cleared the infection (all three tests negative). Mean 14C recovery values at 15 minutes associated with H. pylori-positive status were significantly higher (12.3 [SD 6.8] x 10(-3); n=30; p<0.001) than those associated with H. pylori-negative status (2.1 [0.9] x 10(-3); n=26). Using receiver-operating-characteristic analysis of 15-minute 14C recovery values, a cut-off of 6.5x10(-3) gave the best separation of H. pylori-positive and -negative cases. 14C-UBT had 93% sensitivity, 96% specificity and 95% accuracy. CONCLUSION: 14C-UBT appears to be a reliable noninvasive test for diagnosis of H. pylori infection.     

14C-urea breath test to diagnose gastric Helicobacter pylori colonization

Helicobacter pylori (H. pylori), ex-Campylobacter pylori, is now considered to be the causative agent of active chronic gastritis in humans and may be diagnosed by histology, gram-stain, culture, urease test or noninvasively by 14C-urea breath test. The aim of this study was to determine the sensitivity, specificity, and reproducibility of the breath test as compared with the microbiological (culture) "gold standard". Forty-one subjects were studied. Gastroscopy was performed in all participants and 2 antral mucosa biopsy specimens were taken for urease test and microbiological (gram-stain and culture) studies. The breath test was performed within one week after the gastroscopy. After fasting overnight, a control breath sample was obtained and a standard meal was offered to delay gastric emptying. Then, the participants drank 5 microCi of 14C-urea in 20 ml of water and breath samples were collected at 10, 15, 30 and 60 min in a hyamine-ethanol solution with a p-H indicator. A repeat test was performed in 9 subjects to assess test reproducibility. Twenty-nine subjects (71 percent) were Hp positive and 12 (29 percent) H. pylori negative. A highly significant difference (p less than 0.0001) was observed in 14CO2 exhalation in colonized and non-colonized subjects in samples collected at all times studied. As compared with culture we found that the breath test was 97 percent sensitive and 100 percent specific. We conclude that 14C-urea breath test is a simple, inexpensive, sensitive, and reliable method to detect H. pylori colonization. It is a useful test to epidemiologic and therapeutic trials.     

Interpretation of the 13C-urea breath test in the choice of second- and third-line eradication of Helicobacter pylori infection

Background The urea breath test (UBT) is one of the most accurate methods of assessing Helicobacter pylori status. The predictive value of the test is, however, uncertain. This study was a serial, prospective analysis of the change over time of UBT values after first-, second- and third-line treatments of patients with failed eradication therapy. Methods One hundred thirty-four duodenal ulcer patients with persisting H. pylori infection after first-line triple therapy were enrolled in a cross-over manner to receive either pantoprazole (40 mg twice daily), amoxicillin (1000 mg twice daily), and clarithromycin (500 mg) or ranitidine bismuth citrate (400 mg twice daily), metronidazole (250 mg twice daily), and clarithromycin (500 mg twice daily) for 7 days. Forty-one patients with failed second-line treatment were randomized to receive third-line quadruple therapies with pantoprazole + amoxicillin and tetracycline (500 mg four times daily) and either nitrofurantoin (100 mg three times daily) or bismuth subsalicylate (120 mg four times daily). Breath tests were performed 6 weeks after therapy. The δ¹³CO₂ values (‰) after primary, secondary, and tertiary treatment were analyzed, and the correlation between pretreatment values and the rate of H. pylori eradication was assessed. Results In patients with successful second-line treatment, UBT values decreased from 12.4‰ [confidence interval (CI), 9.7–15.7)] to 2.8‰ (CI, 0.9–2.5) (P = 0.001), and in those with persistent infection, they increased from 13.2‰ (CI, 7.3–19.1) to 19.2‰ (CI, 13.4–25.0) (P = 0.03). After a failed quadruple regimen, UBT values increased from 19.3‰ (CI, 16.2–22.4) to 25.8‰ (CI, 19.8–312.8) (P = 0.03). The correlation between the pretreatment UBT values and the rate of eradication was negative for both second- and third-line therapies. Conclusions Serial assessment showed that UBT values after successive treatments showed a marked tendency to increase over time in failed cases. The significance of this phenomenon must be further studied. It might indicate increased colonization, ongoing resistance, or urease gene overexpression. Higher pretreatment UBT values were associated with lower (<60%) eradication rates. In these cases, alternative/rescue therapies should be chosen.     

Validation of a simplified 13C-urea breath test method for the diagnosis of Helicobacter pylori infection]

OBJECTIVE: To validate a simplified 13C-urea breath test (13C-UBT) method for the diagnosis of H. pylori infection. MATERIAL AND METHODS: Patients referred for gastrointestinal endoscopy and biopsy were included, and a 13C-UBT was performed after a 6-hour fast. Breath samples were collected in 10 ml glass tubes before and 30 min after the simultaneous administration of 50 mg of 13C-urea and 2 g of citric acid in 200 ml of water. All breath samples were analyzed using isotope ratio mass spectrometry. The diagnosis of H. pylori infection was established with a positive culture and/or positive histology and serology. RESULTS: Eighty-eight patients were included, 49 female and 39 male with a mean age of 45 +/- 15 yrs. Fifty-one patients (57.95%) were positive and 30 (34.1%) negative for H. pylori. Seven cases (7.95%) were considered undetermined. The sensitivity, specificity, positive predictive value, and negative predictive value for 13C-UBT were 90.2, 93.3, 95.83, and 84.8%, respectively. Accuracy was 91.4%. CONCLUSIONS: The simultaneous administration of 50 mg of 13C-urea and 2 g of citric acid represents an alternative for the non-invasive diagnosis of H. pylori infection.     

Studies of 13C-urea breath test for diagnosis of Helicobacter pylori infection in Japan

In recent years Helicobacter pylori infection has been implicated in the etiology of a variety of upper gastrointestinal diseases. The aim of this multi-center trial was to search for the cut-off value of the simple ¹³C-urea breath test (¹³C-UBT) for diagnosis of H. pylori infection, and to examine the sensitivity and specificity of ¹³C-UBT for culture, the rapid urease test (CLO test), histology, and serological tests. Two hundred and forty-eight patients participated in this study after giving their informed consent. Endoscopic biopsy specimens were taken from gastric antrum and corpus for culture (190 patients), CLO test (222 patients), and histology (98 patients). A serological test was carried out for all patients. H. pylori infection was established when culture was positive or more than two of the tests, histology, CLO test, and serological test, were positive, and non-infection status was established when the all tests more than two tests were negative. After baseline breath samples were taken, the patients (who had fasted) were given 100 mg of ¹³C-urea in 100 ml water while sitting; they washed out the mouth with water. They were then placed in the left lateral decubitus position for 5 min, and additional breath samples were taken 10, 20, 30, 45, and 60 min after urea administration, with patients in the sitting position. One hundred and sixty-five of the 248 patients were infected, 48 were not infected, and H. pylori infection status was not evaluated in 35 by endoscopic and serological tests. Breath samples at 20 min were employed to determine the cut-off value. Using the receiver operating characteristic (ROC) curve, we determined the cut-off value for a positive UBT at 2.5 Δ‰. The sensitivities of UBT for culture, CLO test, histology, and serological test were 98.4%, 98.6%, 100.0%, and 92.5%, and the specificities were 78.8%, 82.5%, 83.3%, and 87.3%, respectively. The cut-off value of 13C-UBT for the diagnosis of H. pylori infection was 2.5 Δ‰; this test is a simple and non-invasive method for the diagnosis of this infection and has high sensitivity and specificity. Received Nov. 18, 1996; accepted June 20, 1997     

Endoscopic 13C-urea breath test for detection of Helicobacter pylori infection after partial gastrectomy

BACKGROUND/AIMS: It is difficult to interpret the results of 13C-urea breath test (UBT) in gastrectomy patients because the test urea may pass through the stomach faster. The aim of this study is to evaluate the efficacy of the modified endoscopic UBT for detection of Helicobacter pylori (H. pylori) infection in the residual stomach. METHODOLOGY: An endoscopic UBT was performed in 44 patients who had undergone partial gastrectomy. At endoscopy, 20 mL of water containing 100mg of 13C-urea were sprayed onto the gastric mucosa and an intragastric gas sample was immediately collected through the biopsy channel. Breath samples were collected at 20 min after spraying 13C-urea. RESULTS: The intragastric delta13CO2 value in H. pylori-positive patients was significantly higher than those of 20-minute breath samples. The maximum sensitivity and specificity of intragastric samples were 97% and 100% with cutoff point of 5 per thousand, respectively. The sensitivity and specificity of breath samples at 20 min were 71.4% and 66.7% with cutoff point of 0.6 per thousand, respectively. CONCLUSIONS: An endoscopic UBT was superior to a standard UBT to detect H. pylori infection after partial gastrectomy.     

Accurate diagnosis of Helicobacter pylori. 14C-urea breath test

The 14C-urea breath test is an accurate means of identifying the presence of H. pylori infection before and after antimicrobial therapy. Several issues, including out of office analysis, the need for a support structure to perform the test, concerns regarding radiation exposure, and inconsistent reimbursement, have slowed the widespread acceptance of the 14C-urea breath test in clinical practice. Despite these problems, the 14C-urea breath test is simple, rapid, and relatively inexpensive compared with the currently available version of the 13C-urea breath test. As such, the 14C-urea breath test provides an attractive, nonendoscopic means of identifying active H. pylori infection.     

14C-urea breath test for the detection of Helicobacter pylori

The high urease activity of Helicobacter pylori can be used to detect this bacterium by noninvasive breath tests. We have developed a 14C-urea breath test which uses 5 microCi 14C with 50 mg nonradioactive urea. Breath samples are collected at baseline and every 30 min for 2 h. Our study compared the outcome of the breath test to the results of histology and culture of endoscopically obtained gastric biopsies in 84 patients. The breath test discriminated well between the 50 positive patients and the 34 patients negative for Helicobacter pylori: the calculated sensitivity was 100%, specificity 88%, positive predictive value 93%, and negative predictive value 100%. Treatment with bismuth subsalicylate and/or ampicillin resulted in lower counts of exhaled 14CO2 which correlated with histological improvement in gastritis. The 14C-urea breath test is a better "gold standard" for the detection of Helicobacter pylori than histology and/or culture.     

Accuracy of 13C-urea breath test in clinical use for diagnosis of Helicobacter pylori infection

The 13C-urea breath test (UBT) is a noninvasive test for diagnosis of Helicobacter pylori infection of gastric mucosa. The aim of this prospective study was to assess the accuracy of a simple UBT in clinical routine use. METHODS: The study population comprised of 100 patients (49 f, 51 m) requiring diagnostic upper GI endoscopy. One biopsy specimen was taken from the gastric antrum, body and fundus, respectively, for standard histological examination and one additional specimen from each location was transformed into transport medium for cultivation of H. pylori. After vaccination of the culture plates the biopsies were tested for urease activity (UAT). After recovery from endoscopy the patients had to pass an one liter endexspiratory breath sample before and 15 min after drinking 200 ml orange juice, pH 3.6, containing 75 mg of 13C-urea. 13CO2 was measured in the breath samples using isotope-selective nondispersive infrared spectrometry. RESULTS: Defining gold standard groups with all biopsy tests (from antrum and corpus) positive or negative the 13CO2 delta over baseline (DOB) cut-off level of UBT was set at 6.5/1000 in order to best discriminate positive from negative patients (ROC analysis). UBT was positive in 37% of all subjects. Taken UAT and histological examination together (positive when both tests were positive) UBT displayed a sensitivity of 92%, a specificity of 94%, a positive predictive value of 89%, and a negative predictive value of 94%. When including the results of culture sensitivity and negative predictive value reached almost 100%. The mean of the 13CO2-DOB values from H. pylori-positive duodenal or gastric ulcer patients did not differ from controls (H. pylori-positive patients without lesions). The 13CO2-DOB values of the ulcer group were correlated significantly with the active inflammatory component of gastritis in antrum, corpus, and fundus. CONCLUSION: UBT with this setup detects H. pylori infection in clinical routine use with high accuracy. The increase of exhaled 13CO2 does not predict ulcer disease but reflects the degree of active inflammation of gastric mucosa.     

Comparison of a monoclonal antigen stool test （Hp STAR） with the ^13C-urea breath test in monitoring Helicobacter pylori eradication therapy

AIM: To evaluate the agreement between a mAb-based stool test (HP StAR) and the urea breath test (UBT) in monitoring (H pylori) 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 4 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.     

Quantification of Helicobacter pylori infection: Simple and rapid 13C-urea breath test in Taiwan

The ¹³C-urea breath test (¹³C-UBT) is a non-invasive method for detecting Helicobacter pylori. This study was performed to determine the cutoff value and evaluate the sensitivity and specificity of ¹³C-UBT in Taiwan. ¹³C-Urea (100 mg of 99% ¹³C-labeled urea) was dissolved in 50 ml sterile water for the test. The test meal for delaying gastric emptying was 100 ml fresh milk. Patients fasted for at least 6 h. A baseline breath sample was collected 5 min after they had the test meal. Two other samples were collected at 15 and 30 min after the patients ingested the ¹³C-urea. The test was evaluated in 352 patients after routine upper gastrointestinal endoscopy, and the urease test, culture, and histopathology were taken as the gold standards for detecting H. pylori. According to the receiver operating characteristic (ROC) curves, we chose values of 2.8 and 4.2 excess δ¹³CO₂ per mil as the cut-off values for 15 and 30 min, respectively, post ¹³C-urea. The sensitivity and specificity of ¹³C-UBT were 99% and 93% at 15 min, and 98% and 93% at 30 min post ¹³C-urea, respectively. The ¹³C-UBT breath test is an efficient non-invasive method of high sensitivity and high specificity for detecting H. pylori infection. We suggest that the use of fresh milk as the test meal and the detection of excess δ¹³CO₂ 15 min after the ingestion of ¹³C-urea are suitable for the clinical use of ¹³C-UBT. This test is simple and rapid. (Received June 18, 1997; accepted Oct. 30, 1997)