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Medizinischer und gesundheitskonomischer Nutzen der Untersuchung auf Helicobacter pylori-Besiedlung mittels 13C-Harnstoff-Atemtest in der Primrdiagnostik im Vergleich zu invasiven und nichtinvasiven diagnostischen Verfahren

Medizinischer und gesundheitskonomischer Nutzen der Untersuchung auf Helicobacter pylori-Besiedlung mittels 13C-Harnstoff-Atemtest in der Primrdiagnostik im Vergleich zu invasiven und nichtinvasiven diagnostischen Verfahren Efficacy and cost-effectiveness of the 13C-urea breath test as the primary diagnostic investigation for the detection of Helicobacter pylori infection compared to invasive and non-invasive diagnostic tests

Diseases of the gastro-intestinal system are very common in Germany. About 28 million patients are treated for gastro-intestinal illnesses per year. In 2007, gastro-intes- tinal diseases accounted for 34.6 million prescriptions and a turnover of 1.363 billion Euro. A large number of gastroenterological diseases are caused by Helicobacter pylori (H. pylori). H. pylori infections in humans are one of the most common infections in developed countries, even though the incidence rates are decreasing. Accor- ding to the Institute for Microbiology and Hygiene at the University of Freiburg, about 20 to 30 million people (30% of the German population) in Germany are infected. The infection of the mucus layer of the stomach with H. pylori causes usually a chronic inflammatory reaction, resulting in morbidity and mortality in four to six million people in Germany (about 20% of the infected population). In this context, this Health Technology Assessment (HTA) report assesses the medical and health economic benefit of the 13 C-urea breath test compared to other invasive and non-invasive tests used in the primary assessment of H. pylori.

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Evaluation of three commercial enzyme immunoassays compared with the 13C urea breath test for detection of Helicobacter pylori infection

Evaluation of three commercial enzyme immunoassays compared with the 13C urea breath test for detection of Helicobacter pylori infection

C urea breath test as the confirmatory method for H. pylori status to evaluate three commercially available EIA kits designed to detect immunoglobulin G antibodies to H. pylori. These kits were the HM-CAP EIA kit (Enteric Products, Inc.), the PYLORI STAT EIA kit (BioWhittaker, Inc.), and the G.A.P. kit (Bio-Rad Laboratories/Biomerica, Inc.). The evaluations were performed in a double-blind manner with samples from 473 clinically characterized patients. This group included patients with symptom- atic gastrointestinal disorders as well as nonsymptomatic volunteers. The sensitivities of the kits were as follows: HM-CAP, 98.4%; PYLORI STAT, 99.2%; and G.A.P., 100%. The specificities were as follows: HM-CAP, 96.4%; PYLORI STAT, 90.1%; and G.A.P., 26.0%. Although the HM-CAP and PYLORI STAT kits performed comparably, the G.A.P. test yielded significantly more false-positive results and an unacceptably high number of indeterminate results.

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Sex differences in urea breath test results for the diagnosis of Helicobacter pylori infection: a large cross-sectional study

Sex differences in urea breath test results for the diagnosis of Helicobacter pylori infection: a large cross-sectional study

Student’s t test was used to examine differences in mean UBT values among infected persons according to sex, and one-way analysis of variance (ANOVA) was used to examine differences in UBT values according to age, BMI categories, SES, and smoking. Multivariable ana- lyses were performed using mixed linear models to as- sess the relationship between sex and UBT values while controlling for other independent variables; interactions between sex and other independent variables were tested in these models. Pooled and sex-stratified analyses were performed. Two-tailed P < 0.05 was considered signifi- cant. Data were analyzed using SPSS version 23 (IBM, Armonk, New York, USA).

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Applicability of a short/rapid 13C-urea breath test for Helicobacter pylori: retrospective multicenter chart review study

Applicability of a short/rapid 13C-urea breath test for Helicobacter pylori: retrospective multicenter chart review study

A total of 12,751 consecutively selected 13 C urea breath tests performed between 2001 and 2009 were extracted from the files of fifteen gastrointestinal units in Israel, The Netherlands, Switzerland, Germany and Italy, representing approximately 50% of the tests performed during the 9- year period. Some patients underwent a second UBT test after H. pylori eradication. For subjects who had more than one test result, pre and post treatment, all of the identified tests were used. There was no obvious selection bias, as all tests were collected from these centers. 13 C- UBT in the gastroenterology clinical laboratories was used in subjects with gastrointestinal symptoms, such as dys- pepsia, peptic ulcers and gastric malignancy. UBT was given to patients after a three-hour fast.

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Helicobacter pylori Infection in Infants and Toddlers in South America: Concordance between [13C]Urea Breath Test and Monoclonal H  pylori Stool Antigen Test

Helicobacter pylori Infection in Infants and Toddlers in South America: Concordance between [13C]Urea Breath Test and Monoclonal H pylori Stool Antigen Test

For the stool antigen assay, stool samples, collected by parents or care- takers, were maintained at 4°C if there was a refrigerator in the household or at room temperature for up to 8 h before being sent at 4°C to local laboratories, where they were maintained at ⫺ 80°C. The stool samples were transported in dry ice to LPB, Belo Horizonte, Brazil, where they were tested by using a commercial ELISA Premier Platinum HpSA Plus assay (Meridian Bioscience Europe from Launch Diagnostics Ltd., Long- field, United Kingdom) that uses multiple murine monoclonal anti-H. pylori capture antibodies adsorbed to microwells, according to the man- ufacturer’s recommendations. A 10- ␮ l disposable loop was used to dilute stool samples in 500 ␮ l of sample diluent. In the case of liquid of semisolid stools, 100 ␮ l of stools were added to the sample diluent. Optical densities (OD) of ⱖ 0.140 at 450 nm were considered positive, and an OD of ⬍ 0.140 was considered negative, according to the manufacturer’s recommenda- tions. The samples were randomly selected among those in which the time interval between stool and breath sample collection was equal to or less than 30 days.

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Helicobacter pylori infection in infants and toddlers in South America: concordance between [¹³C] urea breath test and monoclonal H. pylori stool antigen test

Helicobacter pylori infection in infants and toddlers in South America: concordance between [¹³C] urea breath test and monoclonal H. pylori stool antigen test

For the stool antigen assay, stool samples, collected by parents or care- takers, were maintained at 4°C if there was a refrigerator in the household or at room temperature for up to 8 h before being sent at 4°C to local laboratories, where they were maintained at ⫺ 80°C. The stool samples were transported in dry ice to LPB, Belo Horizonte, Brazil, where they were tested by using a commercial ELISA Premier Platinum HpSA Plus assay (Meridian Bioscience Europe from Launch Diagnostics Ltd., Long- field, United Kingdom) that uses multiple murine monoclonal anti-H. pylori capture antibodies adsorbed to microwells, according to the man- ufacturer’s recommendations. A 10- ␮ l disposable loop was used to dilute stool samples in 500 ␮ l of sample diluent. In the case of liquid of semisolid stools, 100 ␮ l of stools were added to the sample diluent. Optical densities (OD) of ⱖ 0.140 at 450 nm were considered positive, and an OD of ⬍ 0.140 was considered negative, according to the manufacturer’s recommenda- tions. The samples were randomly selected among those in which the time interval between stool and breath sample collection was equal to or less than 30 days.

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13C-Urea breath test threshold calculation and evaluation for the detection of Helicobacter pylori infection in children

13C-Urea breath test threshold calculation and evaluation for the detection of Helicobacter pylori infection in children

The threshold calculation of this study comprised logistic regressions and iterative modeling analyses. The analyti- cal principle is superior to threshold selection procedures, even if the often used single value dichotomy is replaced by receiver operator characteristics including all test val- ues (for example, [11]). For comparison, we used iterative analyses in a large number of UBTs from symptomatic children in whom gastric biopsies were not performed. These analyses returned threshold values, which were sim- ilar to the aforementioned results, apart from our young- est age group, which had a rather large error. However, a recent study of 3 months to 4 years old Gambian children agreeably complements our findings by obtaining a 5.5 ‰ threshold with a very similar method [16].

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Cost effectiveness of six strategies for Helicobacter pyloridiagnosis and management in uninvestigated dyspepsia assuming a high resource intensity practice pattern

Cost effectiveness of six strategies for Helicobacter pyloridiagnosis and management in uninvestigated dyspepsia assuming a high resource intensity practice pattern

Many diagnostic scenarios require a physician to choose from among a set of related diagnostic tests. For Helico- bacter pylori infection in the setting of dyspepsia, diagnos- tic options include serologic tests, a stool antigen test, a urea breath test, and invasive methods, such as endoscopy with biopsy. These options vary with regard to cost, con- venience, and accuracy. The decision about which test to order may ultimately be a significant driver of downstream economic costs and quality-of-care outcomes. The Ameri- can Gastroenterological Association (AGA) in 2005 recommended that to diagnose Helicobacter pylori infec- tion in patients with dyspepsia, physicians should use either the stool antigen test or the urea breath test. [1,2] Serologic tests were specifically not recommended due to

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Clinical differences of Helicobacter pylori infection in children

Clinical differences of Helicobacter pylori infection in children

The study included 327 children between the age of 24 to 48 months. H. pylori infection in children, parents and siblings was diagnosed using the carbon 13-urea breath test. Children without H. pylori infection were examined each year for 4 subsequent years with the urea breath test. Out of 327 children 28 were infected with H. pylori; and the average age of infected patients was 32.78 months. The rate of new infections per 100 persons a year in chil- dren aged 3–4 years were 4.20, whereas in children aged 4–5 years 2.07. Only 1 child aged 5–8 years was infected. This child’s mother and older siblings were infected with H.  pylori, and the child itself had been bottle-fed after 24 months of age, which was also considered a risk fac- tor for infection. The results of these studies confirm that H. pylori infection occurs mostly in the first years of chil- dren’s life and the risk of infection decreases when the children are over 5 years of age.

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Economic evaluation of test-and-treat and empirical treatment strategies in the eradication of Helicobacter pylori infection; A Markov model in an Iranian adult population

Economic evaluation of test-and-treat and empirical treatment strategies in the eradication of Helicobacter pylori infection; A Markov model in an Iranian adult population

Given the role and importance of timely and accurate diagnosis of infection in the treatment and control of digestive system diseases and disorders, the use of safe, ac- curate and optimal cost-effective diagnostic methods is of a great necessity. Diagnostic tests in two forms of invasive and noninva- sive were introduced and used to diagnose Helicobacter infection. Invasive tests in- clude the rapid urease test and histological examination of gastric mucosal tissue and cell culture. On the other hand, non- invasive tests include serology (such as immunoglobulin G and A; antibodies against cell surface antigens), carbon urea breath test and faecal antigen tests (16). In the meantime, the emphasis on invasive or noninvasive methods depends on some fac- tors such as cost, accuracy and ease of use. Among the above mentioned diagnostic tests, carbon urea breath test, due to its non- invasive nature and ease of use, has been addressed in several studies and many is- sues have been raised about its application (5).

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High prevalence of Helicobacter pylori infection in Malaysian Parkinson&#39;s disease patients

High prevalence of Helicobacter pylori infection in Malaysian Parkinson&#39;s disease patients

This was a cross-sectional comparative study. Consenting PD patients aged $18 years were consecutively recruited from the outpatient clinic. Patients with secondary parkinsonism, Parkinson’s plus, history of antibiotic use within 6 months, and proton pump-inhibitor or H 2 -antagonist use within 4 weeks of the urea breath test (UBT) and those who were unable to perform the UBT were excluded. An age- and sex-matched control group was recruited. Approval from the university research ethics committee was obtained prior to the study.

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Fast and Accurate Quantitative Detection of Helicobacter pylori and Identification of Clarithromycin Resistance Mutations in H  pylori Isolates from Gastric Biopsy Specimens by Real Time PCR

Fast and Accurate Quantitative Detection of Helicobacter pylori and Identification of Clarithromycin Resistance Mutations in H pylori Isolates from Gastric Biopsy Specimens by Real Time PCR

Study design. Biopsy samples were obtained over a 16-month period (July 2000 to October 2001) from 196 dyspeptic patients referred for endoscopy at Henri-Mondor hospital. The mean age of the patients was 51.6 years (range, 19 to 90 years), and 63% of the patients were men. They had either nonulcer dyspepsia (91 patients, 46%), gastroduodenal ulcer (83 patients, 42%), MALT lymphoma of the stomach (19 patients, 10%), or gastric cancer (3 patients, 2%). Three endoscopic biopsy specimens taken from the antrum (3 cm from the pylorus) and three taken from the fundus were sent in formalin for histology. In addition, one biopsy specimen from the antrum and one from the fundus were immediately frozen and kept at ⫺80°C for culture and LC-PCR. Some patients benefited from additional diagnostic tests (serology or urea breath test). Clar- ithromycin susceptibility testing was performed by the E-test method and by LC-PCR as described below. Infection by H. pylori was defined as (i) positivity of culture, (ii) positivity of histology performed by a trained histologist, or (iii) positivity of LC-PCR and of a concomitant indirect test (serology or urea breath test). The bacterial density was evaluated semiquantitatively by culture and histology and quantitatively by LC-PCR, as described below.

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Long-term Follow-up Study of Serum Immunoglobulin G and Immunoglobulin A Antibodies After Helicobacter pyloriEradication

Long-term Follow-up Study of Serum Immunoglobulin G and Immunoglobulin A Antibodies After Helicobacter pyloriEradication

Compared with pretreatment titers, the IgG and IgA antibody levels showed a continuous and signif- icant decrease in successfully treated patients throughout the follow-up periods (Fig 1). Mean titer decreases of the IgG and IgA antibodies were 11% and 32% at 1 month (P , .001), 25% and 46% at 3 months (P , .001), 34% and 52% at 6 months (P , .05), 48% and 61% at 12 months (P , .05), 43% and 60% at 18 months (P 5 .18), and 57% and 67% at 24 months (P 5 .12). In patients with failed eradication, there was no significant decrease of any antibody titer (Fig 2); 1 patient showed a maximum decrease of 30% of IgG at 6 months and 1 patient showed a 28% decrease of IgA at 3 months. According to an index of successful eradication, sensitivity and spec- ificity of each titer decrease percentage are listed in Table 2. In 1 patient in whom 13 C-urea breath test

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Rapid Urease Test and Faecal Antigen Detection for Rapid Diagnosis of Helicobacter pylori Infection in Dyspepsia

Rapid Urease Test and Faecal Antigen Detection for Rapid Diagnosis of Helicobacter pylori Infection in Dyspepsia

In the current study RUT and FAT showed good specificity and sensitivity in patients with positive serology for detection of active H. pylori infection. Non-invasive diagnostic tests such as faecal antigen test, serological parameters and the [13C]-urea breath test serve as surrogate markers of H. pylori gastritis and indicators of ga- stritis severity [4].

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A simple breath test for tuberculosis using ion mobility: A pilot study.

A simple breath test for tuberculosis using ion mobility: A pilot study.

Major advances have been made in TB diagnosis, treatment and mortality since the turn of the century, and the Millennium Development Goal to halt and reverse TB incidence by 2015 has partially been met. Despite this, in 2014 there were still an estimated 9.6 million new TB cases, with 1.5 million deaths [1]. Whilst the majority of those affected are from low- and middle-income countries, the significant burden of co-infection with TB and HIV (Human Immunodeficiency Virus), multi-drug resistance, alongside widespread migration, has resulted in TB remaining a global health concern. A new ambition to end the TB epidemic by 2030 has been set as part of the post-2015 global TB strategy [1]. To achieve this Sustainable Development Goal, the vision of the World Health Organisation (WHO) is for everyone to have access to innovative tools and services required for rapid diagnosis, treatment and care. In line with this, breath analysis for TB diagnosis (within minutes) as opposed to standard microbiological culture, which can take up to 2 months, is attractive.

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A simple breath test for tuberculosis using ion mobility : a pilot study

A simple breath test for tuberculosis using ion mobility : a pilot study

The results indicate that FAIMS, and Ion Mobility Spectrometry (IMS) in particular, has potential as a technology that can be applied to breath testing for clinical diseases including TB. We recognise that we were limited by small sample sizes, sampling of whole breath rather than end-tidal, and undertaking the study in optimal UK hospital conditions as opposed to a low- or middle-income fi eld setting. It is also dif fi cult to determine whether the chemicals being detected were directly associated with the metabolism of the TB pathogen, or the body's general response to infection. However, there is considerable potential for utilising IMS as a simple, rapid, cheap breath test for stratifying suspected TB patients. The ad- vantages of IMS in terms of sensitivity, ease of setup with minimal training and minimal instrumental drift and variability, may pro- vide a solution for targeting TB treatment in a global context. We are now looking to further study IMS technology in a more rigorous way, testing its ef fi cacy for different breath capture techniques and in a variety of clinical circumstances.

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The effect of camicinal (GSK962040), a motilin agonist, on gastric emptying and glucose absorption in feed intolerant critically ill patients: a randomized, blinded, placebo controlled, clinical trial

The effect of camicinal (GSK962040), a motilin agonist, on gastric emptying and glucose absorption in feed intolerant critically ill patients: a randomized, blinded, placebo controlled, clinical trial

An adverse event (AE) was defined as any untoward medical occurrence or unfavorable and unintended sign including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study medication. Events that met the definition of an AE included: any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other safety assessments (e.g., ECGs, radiological scans, vital signs measurements), including those that worsen from baseline, and felt to be clinically significant in the medical and scientific judgment of the invest- igator, exacerbation of a chronic or intermittent pre- existing condition including either an increase in fre- quency and/or intensity of the condition, new conditions detected or diagnosed after study medication administra- tion even though it may have been present prior to the start of the study, and/or signs, symptoms, or the clinical sequelae of a suspected interaction.

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Prediction of BOS by the single breath nitrogen test in double lung transplant recipients

Prediction of BOS by the single breath nitrogen test in double lung transplant recipients

probability increases to 75%, a value that may be consid- ered clinically useful. A drawback is the relatively low prevalence of this combination. Considering the moder- ate regular control scheme in our transplantation unit compared to previous reports, the analysis based on sin- gle test results appears suitable but will necessarily result in more false positive results. Furthermore, as the number of BOS cases was rather small in the present study as well as in previous similar studies, the calcu- lated characteristics are based on small numbers. Another limitation to our study is the retrospective study design which is a risk that the results can be more observational. Preferably, one should apply the N 2 -test

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Retrospective analysis of a lactose breath test in a gastrointestinal symptomatic population of Northeast Italy: use of (H<sub>2</sub>+2CH<sub>4</sub>) versus H<sub>2</sub> threshold

Retrospective analysis of a lactose breath test in a gastrointestinal symptomatic population of Northeast Italy: use of (H<sub>2</sub>+2CH<sub>4</sub>) versus H<sub>2</sub> threshold

Diagnostic data were retrospectively collected, pooled, and analyzed from lactose breath tests of outpatient subjects referring to a community-based laboratory facility in the Veneto Region in Northeast Italy, Data Medica Padova, from January 2014 to June 2016. The facility was part of a group of private health care providers operating under agreement with the public health care system to deliver healthcare to the public. The center was also ISO9001 certified and accred- ited for excellence in health care services by Accreditation Canada International. The retrospective observational study was carried out according to Good Practice in Clinical Research, approved by the Data Medica Group Scientific Technical Committee, and, following national Italian legisla- tion, approved by the local reference Ethics Committee for Clinical Trials of the Province of Padua (DM 2016/01). All study participants provided informed written consent prior to study enrollment.

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PRECLINICAL BLOOD CHEMISTRY SAFETY PROFILE STUDIES OF NARADIYA LAKSMIVILASA RASA ON THE KIDNEY FUNCTION AFTER CHRONIC ADMINISTRATION TO MALE SPRAGUE-DAWLEY RATS

PRECLINICAL BLOOD CHEMISTRY SAFETY PROFILE STUDIES OF NARADIYA LAKSMIVILASA RASA ON THE KIDNEY FUNCTION AFTER CHRONIC ADMINISTRATION TO MALE SPRAGUE-DAWLEY RATS

BUN stands for blood urea nitrogen. The BUN test is often done to check kidney function. BUN Increases by 10-20 mg/dl/day if renal function absent. Serum creatinine is a better measure of renal function and BUN is reabsorbed at renal tubules [31-33]. Decrease of BUN level may be seen in severe liver disease, malnutrition, and sometimes when a person is overhydrated. A decrease of BUN level may indicate lower risk of kidney disease. BUN-to creatinine ratio is considered a reliable test that helps in detecting kidney problems. BUN and creatinine are two compounds found in the blood and the amount of these substances is directly governed by the functioning of the kidneys. The principle behind this ratio is the fact that both urea (BUN) and creatinine are freely filtered by the glomerulus, however urea reabsorbed by the tubules can be regulated (increased or decreased) whereas creatinine reabsorption remains the same (minimal reabsorption) [31-33]. Any dysfunction of the kidneys can increase or decrease the quantity of these compounds in the blood. In this study, NMB noticeably increase the BUN level and BUN to Creatinine ratio. So the drug may have nephrotoxic effect.

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