Share the QR code < / P > < p > with wechat scanning code to friends and circles of friends < / P > < p > on January 6, nuohui Health announced that its Helicobacter pylori detection product youyouguan has obtained the registration application of three types of medical devices approved by the State Drug Administration (nmpa). This is the first Helicobacter pylori test product applicable to "consumer self-test" in China approved by the State Food and drug administration < p > previously approved products for Helicobacter pylori detection are limited to professional medical personnel in medical units. The youyou tube realizes the integrated design of "pregnancy test stick" for sampling and testing for the first time. The user has simple operation, no pain and no trauma. There is no need to take medicine before testing, no need for fasting during testing, and no special requirements for sample collection. After sampling, insert the sampling stick back into the reagent tube, shake it well for 10 seconds, and press the tube cover for 10 minutes to read the results, which has been verified by the registered clinical trial supervised by the State Food and drug administration, It meets the requirements of accuracy, safety and convenience required by "consumer self-test" < p > the registered product of secluded duct is called Helicobacter pylori antigen detection reagent (latex method). Double antibody sandwich method is used to detect whether Helicobacter pylori antigen exists in fecal samples. Helicobacter pylori settles on the surface of gastric mucosal epithelial cells in human body and can fall off with the renewal of gastric mucosal epithelial cells. Therefore, fecal antigen detection is one of the most direct and effective detection methods at present, and has been widely recommended by domestic and international medical guidelines and consensus < p > < p > "the normalization of Xinguan anti epidemic will accelerate the implementation of health management in the home scene. On December 28, 2021, ten ministries and commissions included POCT products in the national key development plan in the" 14th five year plan "for the development of medical equipment industry. This time, the State Food and Drug Administration approved the" consumer self-test "products for the first time, which is an important benefit for the development of home testing industry." Zhu Yeqing, executive director and CEO of nuohui health, said, "We have three insistences. Nuo Fai health will adhere to transforming R & D achievements into more convenient use experience, complete reliable clinical validation, achieve product compliance approval, and continuously innovate user services for medical consumer goods. We hope to help more asymptomatic and high-risk people screen, check and seek medical treatment early, and find problems" without danger ", rather than" after " I can't regret it. "
2023-03-22 10:04:48