Part One-- Helicobacter Pylori. By Shenzhen Zhonghe Headway Bio-Sci & Tech Co., Ltd

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1 Part One-- Helicobacter Pylori (H. Pylori) By Shenzhen Zhonghe Headway Bio-Sci & Tech Co., Ltd

2 Helicobacter Pylori (H. Pylori)

3 Helicobacter Pylori (H. Pylori) a spiral-shaped, flagellated, Gram-negative bacterium inhabiting in gastric mucosa, some adherent to the mucosa. Acid-resistance mechanism, producing urease to catalyze urea hydrolysis to buffering ammonia.

4 The discovery of H. Pylori Discovered by Australians J. Robin Warren and Barry J. Marshall in To prove that H. Pylori was a pathogen, Marshall swallowed these bacteria to cause histological gastritis.

5 The discovery of H. Pylori Warren and Marshall were awarded the Nobel Prize in Medicine in 2005 for their work on H. pylori.

6 H. Pylori: a causative factor for: chronic gastritis peptic ulcer disease gastric carcinoma gastric lymphoma

7 The worldwide prevalence infection of H. Pylori H. pylori has been found in the stomachs of humans in all parts of the world. This organism has been shown to infect more than 50% of the world's population with an incidence up to 80% in developing countries.

8 Transmission of H. Pylori The transmission of H. Pylori can occur by routes of: iatrogenic fecal-oral oral-oral

9 Detection of H. Pylori -- Invasive methods Rapid Urease Test Culture Hisopathology

10 Detection of H. Pylori -- Non-invasive methods Serum Antibody Stool Antigen Urea Breath Test

11 Eradication of H. Pylori The eradication of H. Pylori infection by triple regimens is known to be of proven significant benefit for patients with H. Pylori-associated peptic diseases. 1 PPI + two antibiotics 2 Bismuth Compound + two antibiotics

12 Part Two-- 14 C Urea Breath Test ( 14 C UBT)

13 The history of 14 CUBT In 1987, Graham succeeded in using stable nuclide 13 C to mark urea for the diagnosis of Hp infection based on the characteristics of Hp rich in urease. In 1988, Marshall also gained a satisfactory result using urea [ 14 C] to substitute urea [ 13 C] in the urea [ 14 C] breath test.

14 The principle of 14 CUBT Based on the detection of the enzyme urease, produced by H. Pylori Urea labeled with carbon-14 is ingested by the patient If H. Pylori infection is present, the bacterium s urease enzyme breaks down the urea in the stomach The labeled carbon dioxide ( 14 CO 2 2) is subsequently absorbed in the blood and exhaled Measure the exhaled 14 CO 2 to determine the infection of H. Pylori

15 The principle of 14 CUBT

16 How to conduct a 14 CUBT The test is conducted two hours after meal or with an empty stomach in the morning Swallow a 14 C Urea capsule with water Sit for 15 minutes Blow into a breath card for 3-5 minutes Test the breath card with the analyzer After 5 minutes, the result will be printed

17 The sequence of a 14 C UBT Take a 14 C Urea capsule with water. Sit for 15 minutes. Blow into a breath card for 3-5 minutes until the indicator turns from salmon pink to orange. Test the breath card with the analyzer and get the result. Share the test data via PC connection.

18 The advantages of 14 CUBT The 14 C UBT has been recognized as the gold standard for detection of Helicobacter pylori infection combining the advantages of: Sensitive (Sensitivity up to 95%) Specific (Excellent specificity of 95%-100%) Speed (Test completed in 30 minutes) Simple (One-touch operation) Safe (With negligible g e radiation at burden)

19 Why 14 C UBT surpasses all other tests Non-invasive, free from the trouble of swallowing a tube and cross infection, well tolerated by ypatients Easy to operate Telling the active H. Pylori infection Inexpensive An optimum method for monitoring the therapeutic effect of H. Pylori eradication

20 Is 14 C UBT safe? The answer is absolutely YES!!! For patients: The 14C Urea capsule contains a tiny amount of radioactive material which passes out of the body in a day or so in the urine and breath. The amount of radioactive exposure from the test is less than you would normally receive in one day from nature.

21 For operators: Is 14 C UBT safe? The operator has no access to the radioactivity of 14 C. For the environment: The small doses of 14 C from Urea breath tests are of little significance to the environment and the potential long-term impacts from any releases of 14 C as a result of these tests are insignificant.

22 Exemption and approval The U.S. Nuclear Regulatory Commission (NRC) exempted the distribution of 14 C Urea capsule on Dec. 2, FDA approval for 14 C Urea capsule x.cfm?fuseaction=search.drugdetails

23 国家环境保护总局办公厅 关于批准 C-14 尿素呼胶囊用于幽门螺杆菌感染体内诊断放射性豁免管理申请的函 深圳市中核海得威生物科技有限公司 : 环办函 [2002]143 号 你公司 关于 C-14 尿素胶囊使用的放射性豁免管理申请 收悉 我局已于 2002 年 4 月 16 日在北京召开专家审查会, 并于 5 月 11 日赴深圳进行生产现场检查, 完成了对上述申请的技术审查 鉴于含有 0.75 微居的 C-14 尿素胶囊用于幽门螺杆菌感染体内诊断, 对环境 患者和医生, 其辐射影响都是非常小的, 从辐射防护的角度判断都是安全的 ; 在诊断过程中产生的废物可作为普通废物处理 因此, 含有 0.75 微居的 C-14 尿素胶囊用于幽门螺杆菌感染体内诊断, 无须采取任何辐射防护措施 我局决定批准你公司关于 0.75 微居的 C-14 尿素胶囊用于幽门螺杆菌感染体内诊断的放射性豁免管理的申请 本批准不适用于 C-14 尿素胶囊用于幽门螺杆菌感染体内诊断之外的任何其他用途 特此复函 二 00 二年五月十七日 主题词 : 环保放射性药品批准函办公厅 抄送 : 国家药品监督管理局办公厅, 广东省环境保护局 国家环境保护总局办公厅 2002 年 5 月 20 日印发

24 The instructions for 14 CUBT Do not take antibiotics or Pepto Bismol within one month of the test Upper gastrointestinal hemorrhage within 5 days will impact the accuracy of the test Although h the radiation dose is extremely small, pregnant women are not suggested to undergo the test Make sure the child who takes this test is able to swallow an intact t capsule

25 14 C Urea Breath Test In conclusion, 14 C Urea Breath Test is a non-invasive, cost-effective, safe and simple method of accurately detecting H. Pylori infection!

26 Part Three-- Come to Headway

27 The overall view of Headway

28 Welcome to Headway

29 About us Shenzhen Zhonghe Headway Bio-Sci & Tech Co., Ltd. was established in We are specialized in breath test field. With over one decade s development, we have consolidated our position as the leader in this industry in China. We are the only company in China that is in a position to supply both 14 CU Urea Breath Test analyzers and reagents.

30 Our market situation We have set up numbers of branches in China spreading over 33 major cities and provinces and built a nationwide sales network. We ve occupied the dominant position in domestic breath test reagent market, with 100% market share for 14 C Urea Breath Test kit.

31 Our market situation Our products are widely administered in over two thousand large and medium-sized hospitals in China including most first-grade hospitals. Over 10,000,000 test kits have been consumed by the patients across China. For the year 2008 round the number of For the year 2008 round, the number of people who undergoes the 14 C Urea breath test with our test kits reaches up to 2,100,000.

32 Our products-breath th Test Analyzer Model HUBT-20 Work with our breath card, test the CO 2 collected. Key benefits: Lightweight and compact; One-touch operation makes diagnosis easy and swift; Quick assessment is available in 5 minutes; Measures β-ray by ionization, i no harm caused; High accuracy, meets the clinical requirements; Result will be automatically printed; Clock alarm, English menu, troubleshooting tips

33 Our products-breath th Test Analyzer Model HUBT-20A A new generation upgraded from HUBT-20 Advanced features: Two rooms allows simultaneous tests, improving test efficiency; Professional software available for database management; PC connection realizes information resource sharing;

34 Our Products-Breath Test Kit A breath test kit is composed of: A 14 C Urea capsule + A breath card 40 kits in a sales package

35 Certificates ISO Certificate GMP Certificate

36 Certificates Registration Certificate

37 Our market Prospect With rapid development in the domestic market, we are expanding our market territories globally. Our products have been penetrated in Korea, and now are marching in UAE, Turkey and Iran. Our aim is to promote the clinical efficiency and value for thousands of hospital clients and patients in the world.

38 Thanks! Join our hands in the business for mutual benefits! Copyright 2009 by Shenzhen Zhonghe Headway Bio-Sci & Tech Co., Ltd. All rights reserved.

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