scholarly journals Development of FlexSure® HP—an immunochromatographic method to detect antibodies against Helicobacter pylori

1998 ◽  
Vol 44 (2) ◽  
pp. 293-298 ◽  
Author(s):  
Wayne H Schrier ◽  
Ronald J Schoengold ◽  
Josefina T Baker ◽  
Joyce L Norell ◽  
Corey L Jaseph ◽  
...  

Abstract We describe a solid-phase immunochromatographic serologic test, FlexSure® HP, to detect IgG antibodies against Helicobacter pylori. H. pylori colonize the stomach and proximal duodenum, cause ulcer disease and mucosa-associated lymphoid tissue lymphoma, and have a role in the development of other disorders, including gastric adenocarcinoma. FlexSure HP consists of a test strip, conjugate pad, and absorbent pad, in a novel reverse-flow chromatography format. In these studies, FlexSure HP was demonstrated to be specific for IgG antibodies against H. pylori. The reactive cutoff of the test was consistent with [13C]urea breath test and commercially available ELISAs. FlexSure HP had 94% sensitivity, 88% specificity, and 91% accuracy relative to [13C]urea breath test; and 95% sensitivity, 94% specificity, and 95% overall agreement relative to high-molecular-mass cell-associated protein enzyme immunoassay (HM-CAP EIA). FlexSure HP is a simple-to-perform, visually read test requiring no specialized training, equipment, or instrumentation, and yields rapid, accurate, qualitative results.

2018 ◽  
Vol 2018 ◽  
pp. 1-6 ◽  
Author(s):  
Doron Boltin ◽  
Zohar Levi ◽  
Tsachi Tsadok Perets ◽  
Hemda Schmilovitz-Weiss ◽  
Rachel Gingold-Belfer ◽  
...  

Background. There are continual efforts to identify factors which influence the success of first-line therapy for Helicobacter pylori (H. pylori) infection. The 13C-urea breath test result (C13-UBT) utilizes H. pylori urease activity and is a highly accurate diagnostic assay. We aimed to determine whether the magnitude of C13-UBT result is related to treatment success. Methods. Adult patients who underwent a first-time 13C-urea breath test between January 2010 and January 2016 were included. In order to isolate a naïve test-and-treat population who were unlikely to have undergone an initial endoscopy-based H. pylori test, we excluded patients > 45 years and those with a previous C13-UBT. Data were extracted from the Clalit Health Services laboratory database. Results. A total of 94,590 subjects (36.1% male, age 28.5 ± 6.0 years) who underwent a first-time C13-UBT during the study period were included. C13-UBT was positive in 48,509 (51.3%) subjects. A confirmatory posttreatment C13-UBT was performed in 18,375 (37.8%), and eradication was successful in 12,018 (65.4%). The mean C13-UBT recording was 20.6 ± 16.2 DOB in subjects with successful eradication and 19.5 ± 13.1 DOB in subjects with treatment failure (OR, 1.01; 95% CI 1.00-1.01, p<0.01). Among patients in the upper quintile of C13-UBT measurement, eradication was achieved in 67.6%, compared to 62.6% in the lower quintile (OR, 1.22; 95% CI 1.11-1.35, p<0.01). Subjects in the top 1 percentile (C13-UBT ≥ 70 DOB) achieved eradication in 75.0%, compared to 65.3% among subjects with C13-UBT < 70 DOB (OR, 1.59; 95% CI 1.05-2.41, p<0.01). Conclusions. The superiority in H. pylori eradication observed in subjects with a higher C13-UBT DOB is small but significant. Further studies should examine the physiological and microbiological basis for this finding.


2003 ◽  
Vol 89 (04) ◽  
pp. 741-746 ◽  
Author(s):  
Ann-Sofie Rehnberg ◽  
Marju Hein ◽  
Olga Hegedus ◽  
Per Lindmarker ◽  
Per Hellström ◽  
...  

Summary Helicobacter pylori (H. pylori) infection is associated with peptic ulcer disease and gastric cancer. The eradication of H. pylori is of special interest in patients with congenital bleeding disorders, for whom treatment of gastrointestinal hemorrhage with factor concentrates is costly. The prevalence of H. pylori varies between different populations and identification of high-risk subgroups may allow for more targeted screening and eradication of the infection. We performed a 5-year retrospective study of gastrointestinal bleeding, combined with screening and treatment for H. pylori and a long-term prospective follow-up in 168 Swedish and 23 Estonian patients with hemophilia or von Willebrand disease. The prevalence of seropositivity was lower in Sweden than in Estonia (28 versus 48%, p = 0.03), lower in native Swedes than in non-Nordic immigrants to Sweden (20 versus 76%, p = 0.0001) and lower in patients less than 40 years of age than older patients (16 versus 38%, p = 0.002). The incidence of gastrointestinal hemorrhages among the 35 Swedish patients with active H. pylori infection, confirmed by a urea breath test, was 6.0 per 100 patient-years before eradication therapy versus 1.7 during the prospective followup. A negative urea breath test one month after therapy always remained negative after one year. Screening, followed by treatment of all infected patients, yielded a reduction of direct costs over a 5-year period of 130 US-$ per screened patient. We conclude that screening and eradication therapy for infection with H. pylori in patients with congenital bleeding disorders is an effective and economic strategy.


2013 ◽  
Vol 51 (11) ◽  
pp. 3735-3740 ◽  
Author(s):  
Dulciene Maria Magalhães Queiroz ◽  
Mayuko Saito ◽  
Gifone Aguiar Rocha ◽  
Andreia Maria Camargos Rocha ◽  
Fabrício Freire Melo ◽  
...  

2003 ◽  
Vol 41 (7) ◽  
pp. 3334-3335 ◽  
Author(s):  
L. d. C. C. Cardinali ◽  
G. A. Rocha ◽  
A. M. C. Rocha ◽  
S. B. de Moura ◽  
T. de Figueiredo Soares ◽  
...  

2010 ◽  
Vol 59 (5) ◽  
pp. 588-591 ◽  
Author(s):  
Vincenzo De Francesco ◽  
Angelo Zullo ◽  
Federico Perna ◽  
Floriana Giorgio ◽  
Cesare Hassan ◽  
...  

A correlation between δ over baseline (DOB) values of the [13C]urea breath test (UBT) and Helicobacter pylori clarithromycin resistance has been reported, suggesting a possible predictive role of UBT in therapeutic outcome. However, available data are limited and conflicting. This study aimed to clarify this issue, assessing the possible relationship between H. pylori resistance towards different antibiotics (clarithromycin, metronidazole and levofloxacin) and UBT values. The data showed similar DOB values between susceptible and resistant strains for clarithromycin (46.9±32.3 vs 45.7±30.6; P=0.8), metronidazole (46.4±29.6 vs 47.4±37.9; P=0.8), and levofloxacin (45.0±30.2 vs 54.2±38.4; P=0.08). Likewise, comparable DOB values were observed between susceptible and multidrug-resistant strains (45.4±29.6 vs 54.8±44.8; P=0.1). In conclusion, our data failed to find a significant correlation between UBT values and H. pylori antibiotic resistance.


2019 ◽  
Vol 10 (2) ◽  
pp. 121-124
Author(s):  
Mian Mashhud Ahmed ◽  
Atia Saeed ◽  
Abu Shams Md Hasan Ali Masum ◽  
Md Mohiuddin ◽  
Anisur Rahman

Background: Helicobacter pylori (HP) infection is an important cause of peptic ulcer disease (PUD) in the world. This study was aimed to know the trend of H.P. infection among the symptomatic subjects Method: This was a retrospective observational study conducted from January 2015 to July 2018 in three different hospitals in Dhaka city. Patient who presented with dyspepsia underwent 13C urea breath test. Positive cases were analyzed. Results: A total 1343 patients were taken for UBT where 308 (23%) patients were found positive. The mean age group was 41.21+13.6. Male were more infected (61%) than female (39%). Conclusion: Improving sanitary and hygienic condition of this region along with significantly increasing HP eradication therapy and PPI use by the symptomatic individuals might have contributed to the decreasing trend of infection Anwer Khan Modern Medical College Journal Vol. 10, No. 2: July 2019, P 121-124


2011 ◽  
Vol 48 (2) ◽  
pp. 104-108 ◽  
Author(s):  
Luiz Gonzaga Vaz Coelho ◽  
Arilto Eleutério da Silva Jr ◽  
Maria Clara de Freitas Coelho ◽  
Francisco Guilherme Cancela e Penna ◽  
Rafael Otto Antunes Ferreira ◽  
...  

CONTEXT: The standard doses of 13C-urea in 13C-urea breath test is 75 mg. OBJECTIVE: To assess the diagnostic accuracy of 13C-urea breath test containing 25 mg of 13C-urea comparing with the standard doses of 75 mg in the diagnosis of Helicobacter pylori infection. METHODS: Two hundred seventy adult patients (96 males, 174 females, median age 41 years) performed the standard 13C-urea breath test (75 mg 13C-urea) and repeated the 13C-urea breath test using only 25 mg of 13C-urea within a 2 week interval. The test was performed using an infrared isotope analyzer. Patients were considered positive if delta over baseline was >4.0‰ at the gold standard test. RESULTS: One hundred sixty-one (59.6%) patients were H. pylori negative and 109 (40.4%) were positive by the gold standard test. Using receiver operating characteristic analysis we established a cut-off value of 3.4% as the best value of 25 mg 13C-urea breath test to discriminate positive and negative patients, considering the H. pylori prevalence (95% CI: 23.9-37.3) at our setting. Therefore, we obtained to 25 mg 13C-urea breath test a diagnostic accuracy of 92.9% (95% CI: 88.1-97.9), sensitivity 83.5% (95% CI: 75.4-89.3), specificity 99.4% (95% CI: 96.6-99.9), positive predictive value 98.3% (95% CI: 92.4-99.4), and negative predictive value 93.0% (95% CI: 88.6-96.1). CONCLUSIONS: Low-dose 13C-urea breath test (25 mg 13C-urea) does not reach accuracy sufficient to be recommended in clinical setting where a 30% prevalence of H. pylori infection is observed. Further studies should be done to determine the diagnostic accuracy of low doses of 13C-urea in the urea breath test.


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