Youyou tube, a testing product of nuohui health ® The registration application was approved by the State Food and drug administration

Yiouda health on January 6, today, nuohui Health announced that its Helicobacter pylori detection product youyouguan ® Registration application for class III medical devices approved by nmpa. The product is a consumer self-test product for gastric cancer screening based on the detection of Helicobacter pylori in fecal samples, and Helicobacter pylori is the main carcinogen of gastric cancer. Secluded tube ® The registered product name is 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. It is reported that this is also China's first Helicobacter pylori test product applicable to "consumer self-test" approved by the State Food and drug administration. Previously, the approved products were limited to the testing of professional medical personnel in medical units. Secluded tube ® The integrated design of sampling and detection is realized for the first time. The user's operation is simple, painless and noninvasive. There is no need to take medicine before detection, no need to fasting during detection, and no special requirements for sample collection. After sampling, insert the sampling rod back into the reagent tube, shake it well for 10 seconds, and press the tube cover for 10 minutes to read the results. Data show that the secluded tube ® Taking expiratory method as the gold standard, 1644 effective subjects with suspected Helicobacter pylori infection were included in three tertiary clinical hospitals affiliated to Run Run Run Shaw Hospital of Medical College of Zhejiang University, Zhejiang Provincial People's Hospital and Shougang Hospital of Peking University. The sensitivity was 96.5% and the specificity was 99.1%. Compared with the test results of professionals, the coincidence rate was 100%.