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

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.