The new target TB testing product was approved for sale in April

In April 2020, Suzhou Tsenglan Bio's Mycobacteria-specific cellular immune response test kit (IP-10.TB™ was approved for sale, the world's first approved IP-10 mRNA target-based mycobacteria-specific cell immunoreactive test kit.This IP-10.TB™, developed over a period of 5 years, is designed to provide a new, convenient, fast, accurate and efficient solution for diagnosis and detection of suspected TB patients, in conjunction with the fully automated nucleic acid extraction and reaction system construction system introduced at the same time. After the launch of this product, or will fill the TB-specific cellular immune response detection field lack of fully automatic rapid detection products, but also means that China's TB diagnostic capacity ushered in a major breakthrough.In a clinical study of more than 1,000 cases conducted by well-known domestic TB clinical institutions, IP-10. The detection ™ TB data is completed within a few hours after the whole blood sample is taken, which greatly shortens the detection time of this method. According to the study, IP-10. The clinical sensitivity of TB ™ reached more than 90%, of which 92% was detected in tuberculosis Tuyang cases, 90% in tuberculosis Tuyin cases, and 90% in out-of-tuberculosis cases. At the same time, this product for PPD negative, chest tablets without abnormal TB low-risk population negative rate of 99%. This shows that IP-10. TB™ is of good reference value for the rapid identification and diagnosis of tuberculosis, especially tuberculosis, which is not easily supported by bacteriological evidence, and provides new possibilities for optimizing TB diagnosis and treatment.Eliminating TB by 2050 has a long way to goTB is a very old disease, german scientist Robert E. Lee said in 1882. Robert Koch found that the pathogen of tuberculosis is Bacillus tuberculosis. The bacteria can invade a variety of organs, including the brain, gastrointestinal, heart bag, pelvic cavity, bone, peritina, lymphatic and so on, tuberculosis is also one of the world's TOP10 causes of death.The World Health Organization estimates that about a third of the world's population is currently infected with Mycobacteria tuberculosis and is at risk of developing further into tuberculosis, with an estimated 10 million new TB patients worldwide and nearly 1.491 million people dying from TB in 2018. In 2016, the World Health Organization proposed a global end to the epidemic of tuberculosis by 2035 and a total elimination of TB by 2050.Since the founding of the People's Republic of China, China has attached great importance to the prevention and treatment of tuberculosis, and in 2011 began to implement a five-year plan for the special prevention and treatment of tuberculosis, and gradually set up a three-tiered coverage of provincial, municipal and county levels, with targeted medical institutions, primary health care institutions, disease prevention and control institutions as fulcers of the tuberculosis prevention and control network, free screening and routine treatment of tuberculosis patients. Although china's TB prevention and control level has been significantly improved, but still a high burden of tuberculosis countries, China's existing TB patients about 5-6 million, about 900,000 new cases per year, the form of prevention and control is still serious.Under the existing diagnostic method system ofunder the existing diagnostic method system, the lack of diagnostic capacity and the limited number of cases detected are the bottlenecks that restrict the improvement of the global TB prevention and control level for a long time. Sputum smear tests with a positive rate of less than 30% are still widely used in tuberculosis patients. According to the World Health Organization's Global TB Report 2019, 7 million new TB cases were reported globally in 2018, a 30 percent difference from the 10 million new cases estimated by countries based on national TB prevention and control capacities, creating a pattern of inverted TB cases.At present, TB testing mainly has microbiological testing, biochemistry testing, immunology testing and molecular biology testing and other types, IP-10. TB ™ a new generation of TB cell immunology testing products.The first generation of immunological detection of TB mycosin skin test (TST) was the first method used to diagnose TB infection and is widely used in tuberculosis screening due to its ease of operation and low cost. Our country has explicitly called for screening of close contacts of patients with infectious tuberculosis. In 2013, the Measures for the Prevention and Control of Tuberculosis were issued, expanding the scope of TB screening for high-risk groups, and including faculty and staff in schools and child-care institutions at all levels and new students enrolled in schools as key groups for TB screening. The Action Plan to Stop TB, released in 2019, also sets out the scope of TB screening. TST is susceptible to the cross-reaction of card-mediated seedlings and non-tuberculosis mycobacteria and is less specific, unable to play a greater role in TB testing, the second generation immunological testing γ-interferon release test (IGRA) avoids cross-reaction between antigen and card-based seedlings and non-tuberculosis mycobacteria, thereby improving specificity, however, IGRA involves a large number of manual operations, and the existing product sample incubation time is longer (nearly 24 hours), difficult to apply to TB detection.IP-10. TB™ uses real-time fluorescence PCR technology to detect before and after IP-10 mRNA levels of TB-specific antigen stimulation in whole blood samples, and to determine whether the human body has a cellular immune response to TB specificity. Ip-10 mRNA, which uses instantaneous high stable expression as the detection target, IP-10. TB™ simplifies the operation process while producing more accurate results, greatly shortens the testing time, and only a few hours after sampling is completed, which will help improve the diagnostic and screening efficiency of TB, and it is precisely because of the fast, highly stable expression of the target to be tested that this convenient and fast diagnostic product has the expected clinical performance in effectively reducing background interference and immunodeficiency in special populations.In recent years, IP-10 has been widely involved in the basic research of human inflammation and is regarded as the ideal target for tuberculosis testing. However, due to the difficulty of IP-10mRNA capture and the complexity of the industrial process, there have been few IP-10mRNA-based TB detection products. IP-10. The approval ™ TB is a major step forward in the process of productization of TB detection technology for global IP-10 targets.Founded in 2015, Genesis is composed of senior clinical microbiologists, protein genomics experts, cell molecular biology experts, bioinsynatics experts and professional market operations teams, who are based on a deep understanding of customer needs and clinical value, through a variety of Technical breakthroughs and micro-innovations optimize product processes and clinical performance to ensure that IP-10 mRNA is rapidly multiplied and accurately captured in the human whole blood, resulting in a technical path of IP-10 mRNA in-body release and stable and reliable diagnostic products.Since its inception 5 years ago, in addition to deep cultivation and layout in the field of TB detection, Tsenglan Bio has also been actively exploring the diagnosis of pathogens of infectious diseases in other fields and has provided a series of advanced product solutions, and the arterial network will continue to focus on the follow-up progress of Tsenglan Bio. 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