Beijing News (reporter Wang Kara) On January 6, Nuohui Health announced that its Helicobacter pylori detection product Phantom Tube has obtained the registration application of class III medical devices approved by the State Food and Drug Administration. This is the first Helicobacter pylori testing product approved by the State Food and Drug Administration for "consumer self-testing".
"Pregnancy stick" type detection of Helicobacter pylori products on the market
Previously approved products for Helicobacter pylori testing were limited to medical professionals testing in medical units. For the first time, the ghost tube realizes the integrated design of sampling and detection "pregnancy test stick", the user operation is simple, painless and non-invasive, no need to take medication before testing, no need to empty stomach during detection, no special requirements for sample collection, after sampling, the sampling rod is inserted back into the reagent tube, shake well for 10 seconds, and read the results after pressing the tube cover for 10 minutes. Verified by the registered clinical trials supervised by the State Food and Drug Administration, The Ghost Tube can fully meet the accurate, safe and convenient requirements required by "consumer self-testing".
The registered product is called Helicobacter pylori antigen detection reagent (latex method), which uses advanced dual antibody sandwich method to detect the presence of Helicobacter pylori antigen in stool samples. Helicobacter pylori settled in the human body on the surface of gastric mucosal epithelial cells, which can fall off with the renewal of gastric mucosal epithelial cells, fecal antigen detection is one of the most direct and effective detection methods, and has been widely recommended by domestic and international medical guidelines and consensus.
In the three tertiary clinical hospitals affiliated to Zhejiang University School of Medicine, Zhejiang Provincial People's Hospital and Peking University Shougang Hospital, a total of 1644 cases of effective subjects with suspected Helicobacter pylori infection were included, with sensitivity of 96.5% and specificity of 99.1%, and the self-test results of subjects were compared with the test results of professionals, and the compliance rate reached 100%.
"This trial has fully achieved the clinical research goal, and the participants who have a positive test result on the ghost tube are very likely to be infected, and it is recommended to seek medical treatment in time to determine the next step of treatment." Professor Pan Wensheng, a researcher of the Yuyu Tube Project and director of the Department of Gastroenterology of Zhejiang Provincial People's Hospital, hopes that the home test of "consumer self-testing" can enhance the public's awareness of autonomous health management, "Do not get sick before seeking medical treatment, and seeing a doctor can also become passive to active." ”
Helicobacter pylori control should be carried out on a family basis
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%, mainly through the mouth-to-mouth route, is highly contagious, and rarely heals without treatment. Gastritis can be caused by almost all infected people, about 15%-20% of patients develop peptic ulcers, and about 1% develop gastric malignancies. China's annual new stomach cancer patients account for 42.6% of the world, the domestic gastric cancer early diagnosis rate is less than 20%, and the 5-year survival rate of gastric cancer patients is only 27.4%. Helicobacter pylori infection is considered the most important controllable risk factor for preventing stomach cancer. Household circulation data show that 64.6% of households in China have at least one family member with Helicobacter pylori infection.
On November 26, 2021, Chinese scholar Li Zhaoshen led the publication of the "Consensus Report on the Prevention and Control and Management of Helicobacter pylori Infection in Chinese Families (2021 Edition)" in The top journal in the field of global digestion, Gut, pointed out that the management of Helicobacter pylori infection in China is mainly based on the "detection and treatment" strategy and "screening and treatment" strategy for individuals, and the problem of Helicobacter pylori infection transmission between family members needs to be paid attention to, intergenerational transmission within the family, transmission between young children, Transmission between mother and child, transmission of shared meals, etc., to a certain extent, led to the failure of effective prevention and control of Helicobacter pylori infection.
On December 28, 2021, ten ministries and commissions listed POCT (instant inspection) products in the "14th Five-Year Plan for the Development of Medical Equipment Industry" in the national key development plan. Zhu Yeqing, executive director and CEO of Nuohui Health, said that the State Food and Drug Administration approved the "consumer self-test" product for the first time, which is an important benefit for the development of the home testing industry. "I hope to help more asymptomatic people and high-risk people to screen early and check for medical treatment early, and when problems are found, 'there is no danger', rather than 'regret'." Zhu Yeqing said.
Proofreading Liu Baoqing
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