Health Park | “Consumer self-test” Helicobacter pylori helps early screening, early examination and early medical treatmentFly into the homes of ordinary people
Helicobacter pylori infection is an internationally recognized type I carcinogen of gastric cancer. The infection rate of Helicobacter pylori in China is as high as 40%-60%. It is mainly transmitted through the oral-oral route. It is highly infectious and rarely recovers without treatment. Almost all infected persons can cause gastritis, about 15%-20% develop peptic ulcer, and about 1% develop gastric malignant tumor. According to the “Fifth National Consensus Report on the Treatment of Helicobacter Pylori Infection”, Helicobacter pylori gastritis is an infectious disease regardless of asymptomatic or complication. The eradication treatment can be extended to asymptomatic patients.
On November 26, 2021, Chinese scholar Li Zhaoshen presented the “Consensus Report on the Prevention, Control and Management of Helicobacter Pylori Infection in Chinese Families (2021 Edition)” in Gut (IF=23.0), a top journal in the global digestive field. The report pointed out that the current management of Helicobacter pylori infection in China mainly adopts individual “detection and treatment” strategies and “screening and treatment” strategies, and the spread of Helicobacter pylori infection among family members needs to be paid attention to. Internal intergenerational transmission, transmission between young children, transmission between mothers and infants, transmission of shared meals, etc., to a certain extent, have caused Helicobacter pylori infection to not be effectively prevented and controlled.
China accounts for 42.6% of the world’s new cases of gastric cancer each year, but the domestic early diagnosis rate of gastric cancer is less than 20%, and the 5-year survival rate of gastric cancer patients is only 27.4%. Helicobacter pylori infection is currently the most important controllable risk factor for the prevention of gastric cancer. Recent data on family circulation shows that 64.6% of households in China have at least one family member with Helicobacter pylori infection. The prevention and treatment of Helicobacter pylori should be carried out on a family basis.
A few days ago, Helicobacter pylori detection product pylorus®Approved by the National Medical Products Administration (NMPA) for the registration of Class III medical devices. This is China‘s first Helicobacter pylori test product that is suitable for “consumer self-testing” approved by the State Food and Drug Administration. On December 28, 2021, ten ministries and commissions included POCT (Instant On-the-Spot Inspection) products in the National Key Development Plan in the “Fourteenth Five-Year” Medical Equipment Industry Development Plan.
The previously approved products for Helicobacter pylori testing are limited to testing by professional medical personnel in medical units.Pylorus®It is the first time to realize the integrated design of “pregnancy test stick” for sampling and testing. It is easy for users to operate, painless and noninvasive. There is no need to take medicine before testing, and no need to fasting during testing. There are no special requirements for sample collection. After sampling, the sample stick is inserted into the reagent tube. Shake well for 10 seconds, and the results can be read 10 minutes after pressing the tube cap. The registered clinical trial verification supervised by the State Drug Administration fully meets the requirements of accuracy, safety and convenience required by “consumer self-testing”.
Pylorus®The registered product is called Helicobacter pylori antigen detection reagent (latex method), which uses an advanced double antibody sandwich method to detect the presence of Helicobacter pylori antigen in stool samples. Helicobacter pylori colonizes the surface of gastric mucosal epithelial cells in the human body, and can fall off with the renewal of gastric mucosal epithelial cells. Therefore, stool antigen detection is currently one of the most direct and effective detection methods, and it has been widely recommended by domestic and international medical guidelines and consensus. It will help more asymptomatic people and high-risk groups to get early screening, early examination and early medical treatment.
Editor: Pan Jiayi