["HELICARB" - the first Russian breath test kit with 99 % C-urea for Helicobacter pylori: from idea to registration].

R. Plavnik, S. Rapoport, K. Plavnik, A. R. Elman, V. I. Nevmerzhickij
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引用次数: 2

Abstract

The present study was aimed to develop and introduce in medical practice the first Russian kit for the C-urea breath test of Helicobacter pylori. The newly created kit was given the commercial name «HELICARB» and successfully passed technical, toxicological, clinical, and laboratory testing. The optimal dose of 13C-urea was determined and various devices needed to perform the test were compared. The results were approved by the Federal Service for Supervision in the health sector Roszdravnadzor) that issued the Registration certificate № RZN 2016/3773 (order № 1641 of 02.29.2016), which gives the right to manufacture and use the «HELICARB» test kit at the territory of the Russian Federation.
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[“HELICARB”-俄罗斯首款含99% c -尿素的幽门螺杆菌呼吸测试试剂盒:从想法到注册]。
本研究旨在开发并在医疗实践中引入第一个俄罗斯试剂盒用于幽门螺杆菌c -尿素呼气试验。新创建的试剂盒被赋予商业名称«HELICARB»,并成功地通过了技术、毒理学、临床和实验室测试。确定了13c -尿素的最佳剂量,并比较了进行试验所需的各种装置。结果得到了联邦卫生部门监督局(Roszdravnadzor)的批准,并颁发了№RZN 2016/3773注册证书(2016年2月29日第1641号命令),该证书授予了在俄罗斯联邦境内生产和使用“HELICARB”检测试剂盒的权利。
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