Influence of Age on 13C-Urea Breath Test Results in Children

Kindermann, Angelika; Demmelmair, Hans; Koletzko, Berthold; Krauss‐Etschmann, Susanne; Wiebecke, B; Koletzko, Sibylle

doi:10.1097/00005176-200001000-00023

Cited by 125 publications

(120 citation statements)

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“…For the rapid urease test (n ϭ 157) and for bacterial culture (n ϭ 153), one antral specimen each was obtained. Biopsies for culture were transported to the local microbiological laboratory in transport media and were processed within 4 h. The UBT (n ϭ 150) was performed as previously described (6). Briefly, after a fasting period of at least 4 h, a baseline breath sample was obtained using a breath bag or, in very young children, a face mask.…”

Section: Patientsmentioning

confidence: 99%

“…Most serological tests show a low sensitivity in young children (5,7,8,19). The [ 13 C]urea breath test (UBT) gives an excellent performance, in both, adults and children, but specificity decreases in very young children, and collection of exhaled air is difficult in this age group (2,6). Recently an enzyme immunoassay (EIA) based on polyclonal antibodies was developed for detection of H. pylori antigen in stool.…”

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Evaluation of a Novel Rapid One-Step Immunochromatographic Assay for Detection of Monoclonal Helicobacter pylori Antigen in Stool Samples from Children

et al. 2005

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A new rapid one-step immunochromatographic test using monoclonal antibodies for detection of Helicobacter pylori antigen in stool in children was evaluated on coded stool samples from 159 children (mean age, 9.7 ؎ 5.0 years; 118 from Munich, 41 from Vienna): 86 children were H. pylori infected defined by positive culture and/or >2 other positive tests ( Helicobacter pylori infection is the major cause of peptic ulcer disease and chronic gastritis and is almost always acquired in early childhood. For the diagnosis of H. pylori infection, gastrointestinal endoscopy with concordant results of biopsy based methods (culture, histology, and rapid urease test) is considered to be the "gold standard." Several noninvasive methods for the detection of H. pylori infection are available. In children, tests must be reliable in all age groups (8). Most serological tests show a low sensitivity in young children (5,7,8,19). The [ 13 C]urea breath test (UBT) gives an excellent performance, in both, adults and children, but specificity decreases in very young children, and collection of exhaled air is difficult in this age group (2, 6). Recently an enzyme immunoassay (EIA) based on polyclonal antibodies was developed for detection of H. pylori antigen in stool. Results of different studies showed conflicting results indicating large test to test variability, both pre-and posttreatment in children and adults (4,10,13,(16)(17)(18). In contrast, stool EIA based on monoclonal antibodies showed excellent results, with very high sensitivity and specificity (9, 13). The Immunocard STAT! HpSA (Meridian Bioscience Europe) is a novel one-step immunochromatographic quick test based on detection of monoclonal antibodies to H. pylori antigen in feces. The aim of this study was to evaluate this test for detection of H. pylori infection in a large number of children before and after H. pylori eradication therapy in comparison to a well-defined H. pylori status established by the results of invasive diagnostic techniques and the UBT. MATERIALS AND METHODS Patients.For the evaluation prior to first therapy, 159 children (80 girls, 79 boys, mean age 9.7 Ϯ 5.0 years) were enrolled in two pediatric hospitals (Munich, n ϭ 118; Vienna, n ϭ 41). All children underwent upper gastrointestinal endoscopy because of abdominal symptoms suggestive of organic disease. None of the children had been treated for H. pylori infection in the past. Children were excluded if they took antibiotic or acid-suppressive drugs (proton pump inhibitors, H 2 -receptor antagonists, antacids, bismuth preparations) within 4 weeks prior to testing, if they had diarrhea, or if the H. pylori status was not clearly defined as described below. In our centers, about 1 out of 9 children undergoing upper endoscopy is H. pylori infected. To have a meaningful number of H. pylori-infected patients in relation to the total number of tests performed, we included all H. pylori-positive children who fulfilled the inclusion criteria and selected randomly an equal number of noninfected children f...

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Section: Patientsmentioning

confidence: 99%

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confidence: 99%

Evaluation of a Novel Rapid One-Step Immunochromatographic Assay for Detection of Monoclonal Helicobacter pylori Antigen in Stool Samples from Children

et al. 2005

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“…A major advantage of fecal tests is the independence of the test accuracy from the child's age. While both serology (6,12) and UBT (10,11,25) perform with lower accuracy in young children, this is not the case for stool tests. Our study included a larger proportion of very young patients than recent studies of fecal antigen tests (16,23).…”

Section: Discussionmentioning

confidence: 95%

“…One antral specimen was obtained for the rapid urease test and another for bacterial culture; this specimen was transported to the local microbiological laboratory in transport medium and processed within 4 hours. UBT was performed according to a standardized protocol, described previously (11). The test was considered positive when the delta over baseline value was Ն5‰.…”

Section: Methodsmentioning

confidence: 99%

“…Serological tests are not appropriate, since they cannot distinguish between a present and previous infection and, in addition, they have a low sensitivity in children younger than 12 years of age (6, 13). The [ 13 C]urea breath test (UBT) is the preferred noninvasive diagnostic tool and gives excellent performance for both adults and children, but specificity decreases in very young and mentally disabled children who are not able to cooperate with the test procedure (10,11,25). So far, tests for detection of H. pylori antigen in stool samples are the only noninvasive diagnostic tools which do not show an age dependence for the diagnostic accuracy (14, 15).…”

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Improved Performance of a Rapid Office-Based Stool Test for Detection of Helicobacter pylori in Children before and after Therapy

et al. 2009

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A modified version of a rapid office based one-step monoclonal immunoassay for detection of Helicobacter pylori antigen in stool samples from children was evaluated against biopsy specimen-based methods and compared to a monoclonal enzyme immunoassay using the same antigen. Blinded stool samples from 185 children (0.3 to 18.2 years) were investigated at the time of upper endoscopy prior to anti-H. pylori therapy; 62 children were H. pylori infected and 123 noninfected according to predefined reference standards. Samples obtained 6 to 8 weeks after anti-H. pylori therapy were available from 58 children (3.8 to 17.7 years) and were compared to results of the [ 13 C]urea breath test (14/58 were positive). The rapid stool tests were performed by two independent readers. Of 243 rapid tests performed, 1 (0.4%) was invalid for technical reasons. Equivocal results (very weak line) were reported 16 times by reader 1 and 27 times by reader 2. When equivocal results were considered positive, the two observers agreed on 76 positive and 160 negative results and disagreed on 7 samples (2.9%). The sensitivity was 90.8% for reader 1 and 85.5% for reader 2, and the specificity was 91.0% and 93.4%, respectively. The monoclonal enzyme immunoassay revealed a sensitivity and specificity of 94.7% and 97.6%, respectively. The modified chromatographic immunoassay is a good alternative in settings or situations when the monoclonal enzyme immunoassay or the [ 13 C]urea breath test are not available or feasible. In order to improve sensitivity, very weak lines should be considered positive test results.Several noninvasive methods are available for the diagnosis of H. pylori infection (5, 14). Serological tests are not appropriate, since they cannot distinguish between a present and previous infection and, in addition, they have a low sensitivity in children younger than 12 years of age (6, 13). The [ 13 C]urea breath test (UBT) is the preferred noninvasive diagnostic tool and gives excellent performance for both adults and children, but specificity decreases in very young and mentally disabled children who are not able to cooperate with the test procedure (10,11,25). So far, tests for detection of H. pylori antigen in stool samples are the only noninvasive diagnostic tools which do not show an age dependence for the diagnostic accuracy (14, 15). This makes stool tests very attractive, particularly for young children and for epidemiological studies. Several tests have been developed, but validation studies showed differences in performance. An enzyme immunoassay (EIA) based on polyclonal antibodies that was developed by the Meridian Company has been validated in several studies, with controversial results (17,20,24). Lack of accuracy is obviously related to intertest variability (19). In contrast, EIA based on monoclonal antibodies showed consistently excellent results, with very high sensitivity and specificity in both children and adults (15,21).A meta-analysis with head-to-head comparison has judged the monoclonal EIA superior to the po...

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Non-invasive diagnostic tests forHelicobacter pyloriinfection

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Takwoingi

Siddique

et al. 2018

Cochrane Database of Systematic Reviews

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In people without a history of gastrectomy and those who have not recently had antibiotics or proton ,pump inhibitors, urea breath tests had high diagnostic accuracy while serology and stool antigen tests were less accurate for diagnosis of Helicobacter pylori infection.This is based on an indirect test comparison (with potential for bias due to confounding), as evidence from direct comparisons was limited or unavailable. The thresholds used for these tests were highly variable and we were unable to identify specific thresholds that might be useful in clinical practice.We need further comparative studies of high methodological quality to obtain more reliable evidence of relative accuracy between the tests. Such studies should be conducted prospectively in a representative spectrum of participants and clearly reported to ensure low risk of bias. Most importantly, studies should prespecify and clearly report thresholds used, and should avoid inappropriate exclusions.

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Influence of Age on 13C-Urea Breath Test Results in Children

Cited by 125 publications

References 21 publications

Evaluation of a Novel Rapid One-Step Immunochromatographic Assay for Detection of Monoclonal Helicobacter pylori Antigen in Stool Samples from Children

Evaluation of a Novel Rapid One-Step Immunochromatographic Assay for Detection of Monoclonal Helicobacter pylori Antigen in Stool Samples from Children

Improved Performance of a Rapid Office-Based Stool Test for Detection of Helicobacter pylori in Children before and after Therapy

Non-invasive diagnostic tests forHelicobacter pyloriinfection

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