¹³C-Urea breath test kit for Helicobacter pylori infection

Product catalog summary

Introduction
The document discusses the 13C-urea breath test for detecting Helicobacter pylori, a bacterium responsible for various gastrointestinal issues. The test is internationally approved and widely used due to its high accuracy and non-invasive nature.

Helicobacter Pylori Infection
Helicobacter pylori infects about 50% of the global population, with European infection rates between 35-40%. The infection can lead to gastritis, dyspeptic complaints, and ulcers, necessitating its eradication due to associated physical, emotional, and economic burdens.

13C-Urea Breath Test
The test is recognized as the best diagnostic tool for H. pylori infection, offering high specificity (98.5%) and sensitivity (97.9%). It is suitable for both diagnosis and post-eradication monitoring, and is approved for use in children aged 3-11.

Test Procedure
Patients must fast for 4-6 hours before the test. The procedure involves collecting baseline breath samples, administering a 13C-urea solution, and collecting a second set of breath samples after 30 minutes. The presence of H. pylori is confirmed if the difference in 13C/12C ratios exceeds 4‰.

Analysis and Equipment
The breath samples are analyzed using Isotope Ratio Mass Spectrometry (IRMS). The ABCA2 spectrometer is highlighted for its superior performance and versatility in various 13C applications.

Unique Features
The test is easy to use, non-invasive, and has no known contraindications. It is safe for use during pregnancy and lactation and is cost-effective, often eliminating the need for endoscopy.

Product Information
Sercon Limited offers the 13C-Urea breath test for both adults and children, with products registered across the European Union and other countries.

Certifications
The company is ISO 9001:2015 and ISO 13485:2016 certified, ensuring high standards in product quality and safety.

Catalog excerpts

¹³C-Urea breath test kit for Helicobacter pylori infection-1

Helicobacter Test C-urea breath test for Helicobacter pylori detection

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Helicobacter pylori infection. A worldwide problem GASTRITIS LEADS TO HELICOBACTER PYLORI INFECTION LEADS TO HELICOBACTER PYLORI WORLDWIDE INFECTION RATE DETECTABLE GASTRITIS DYSPEPTIC COMPLAINTS DUODENAL AND PEPTIC ULCER On average, 50 % of the world‘s population is already infected with Helicobacter pylori. Infection rates in Europe range from 35 - 40%. Helicobacter pylori infection places the affected person under considerable physical and emotional strain. High economic costs lead to the necessity for eradication of the bacterium. Management of Helicobacter pylori infection-the Maastricht...

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Management of Helicobacter pylori infection-the Maastricht V/ Florence Consensus Report. Gut, 2017; 66:(1). P Malfertheiner, F Megraud, C A O`Morain, et.al. Comparison of non-invasive tests to detect Helicobacter pylori infection in children and adolescents: Results of a multicenter European study. Mégraud, F. et al.; J. Pediatrics, 2005, 146 (2):198. Utility and acceptability of INFAI 13C-urea breath test. Alberti H. et al.; BMJ, 2002, 324: 485. Validity of a novel biopsy urease test (HUT) and a simplified 13C-urea breath test for diagnosis of H.pylori infection and estimation of the severity...

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ANALYSIS ANALYSIS OF THE BREATH TEST Helicobacter test is safe, reliable, cost-saving, and can be performed easily and fast. The analysis of the breath samples is carried out by means of Isotope Ratio Mass Spectrometry (IRMS). The European Medicines Agency (EMA) approved specifications for their execution. TEST KIT FOR MASS SPECTROMETRY EVALUATION An infection with Helicobacter pylori is regarded as proven if the difference in 13C/12C of 00-minute-value (t0) and 30-minute-value (t30) exceeds 4‰. ABCA2 ISO13485 CERTIFIED The ABCA2 is the high performance, high sample throughput isotope ratio mass...

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Helicobacter Test for adults and adolescents (mass spectrometry) EU/1/97/045/001 Helicobacter Test for children of the age 3-11 (mass spectrometry) EU/1/97/045/003 UNIQUE FEATURES • Internationally approved Helicobacter Test is registered in all countries of the European Union and subsequently accepted by many other countries. • Easy to use The simple and patient friendly test protocol ensures a high degree of reliability and compliance. • Non-invasive 13C-urea is already present in the human body so there is no reason to expect any harmful side effects. The test can be used during pregnancy...

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ISO 9001:2015 Certified ISO 13485:2016 Certified Sercon Limited, Unit 3B, Crewe Trade Park, Gateway, Crewe, Cheshire CW1 6JT UK Tel: +44 (0)1270 580008 Email: [email protected] www.sercongroup.com C Like us on Facebook “SerconLimited” L Follow us on Twitter @SerconLimited January 2020

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