On January 6, Novell Health announced that its Helicobacter pylori detection product youyou tube had obtained the registration application for class III medical devices approved by the State Food and drug administration. This is the first Helicobacter pylori test product applicable to "consumer self-test" in China approved by the State Food and drug administration.
The previously approved products for Helicobacter pylori detection are limited to the detection of 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 fully meets the requirements of accuracy, safety and convenience required by "consumer self-test".
The registered product of youyouguan is called Helicobacter pylori antigen detection reagent (latex method). The advanced double antibody sandwich method is used to detect the presence of Helicobacter pylori antigen 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, which has been widely recommended by Chinese Xi'An International Medical Investment Company Limited(000516) guidelines and consensus.
"The normalization of covid-19 epidemic resistance 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 the home testing industry." Zhu Yeqing, executive director and CEO of nuohui health, said, "Nuohui health will adhere to transforming R & D achievements into a more convenient use experience, complete reliable clinical validation, achieve product compliance approval, and continue to provide user services for Innovation Medical Management Co.Ltd(002173) 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' regret '."
Helicobacter pylori infection is an internationally recognized class I carcinogen of gastric cancer. The infection rate of Helicobacter pylori in China is as high as 40% - 60%, which is mainly transmitted through mouth-to-mouth. It is highly infectious and rarely cured without treatment. Almost all infected people can cause gastritis, about 15-20% of them have peptic ulcer and about 1% of them have gastric malignant tumor. According to the fifth consensus report on Helicobacter pylori infection, Helicobacter pylori gastritis is an infectious disease regardless of symptoms or complications. Eradication therapy can be extended to asymptomatic patients.
It is reported that the youyou tube takes the exhalation method as the gold standard, and 1644 effective subjects suspected of Helicobacter pylori infection are included in three tertiary clinical hospitals affiliated to Shaw Hospital of Medical College of Zhejiang University, Zhejiang Provincial People's Hospital and Shougang Hospital of Peking University, with a sensitivity of 96.5% and a specificity of 99.1%. The self-test results of the subjects are compared with those of professionals, The coincidence rate reached 100%.
(China Securities Journal · China Securities Network)
