

The World Health Organization (WHO) reports that approximately 1.8 million people worldwide die each year from diarrhoeal diseases, most of which are attributed to diets contaminated with foodborne pathogens. About 60% of the food safety report issued by my country's National Health and Family Planning Commission are caused by contamination by foodborne pathogens such as Salmonella, Listeria monocytogenes, Vibrio parahaemolyticus, and Staphylococcus aureus. "Rapid Detection-Risk Assessment-Early Warning Release" is an internationally accepted foodborne pathogen control system. The reliance on imports for rapid testing products such as immunology is the main reason for the frequent occurrence of food safety accidents in my country. With the support of national, provincial and ministerial projects such as the "973" Plan, this project uses the establishment of monoclonal antibodies to foodborne pathogenic bacteria as the entry point to carry out bacterial macroarray visualization, high-throughput screening of hybridomas, and a series of research on monoclonal antibody library establishment, antibody optimization and pairing, product performance optimization, and risk assessment software development have been carried out. A number of rapid detection products and software copyrights with independent intellectual property rights have been obtained, and they have been industrially used. The main innovations of the project are as follows:
- Based on the "Rapid Screening Technology for Visualized Antigen Macroarray Hybridoma". Monoclonal antibodies, the core technology for rapid detection of foodborne pathogens, are monopolized by foreign countries, which is the main reason why my country's "rapid detection-risk assessment-early warning release" is difficult to effectively implement. The diversity of bacterial species is the biggest technical obstacle to establishing a "hybridoma bank" of food-borne pathogens and then a "monoclonal antibody bank". This study carried out a series of creative technical improvements to the high-throughput detection technology of "biochip", and successfully developed a "visual bacterial macro array" visible to the naked eye. Compared with the conventional hybridoma screening and library building method, the screening efficiency of this method can reach 96 hybridomas/2.5h, and 600 hybridomas can be screened per day. Conventional screening can screen up to 6 hybridomas per day, and the screening efficiency is improved by nearly 100 times., this technology has obtained an invention patent. Based on this technology, my country's first monoclonal antibody library for foodborne pathogens has reached more than 2400 monoclonal antibodies, which is the core guarantee for rapid detection of localized products. Among them, 19 hybridomas producing high-specific antibodies are collected by China Fungus Collection.
- Localization of products for rapid detection of foodborne pathogens. Based on the antibody library, we have independently developed more than 100 products in five series, including monoclonal antibodies to foodborne pathogens such as Salmonella, immunochromatography test strips, enzyme-linked immunoassay kits, immunoPCR kits, and loop-mediated constant temperature amplification kits. Tests by authoritative organizations have shown that the product sensitivity, stability, accuracy and other indicators have reached similar imported products, but the price is only one-tenth to one-third of that of imported products. Obtained 27 invention patents.
- Accurate risk assessment and early warning of foodborne pathogens. By applying rapid testing products to full-process testing such as food production, processing, storage and transportation, after obtaining test data, using classic predictive microbiology theory to analyze, simulate, and test, a "microbial rapid risk assessment software" has been developed. The software can conduct accurate risk assessment and early warning of high-risk links where food safety accidents may occur. Enterprises can prevent and deal with them early according to the early warning tips of the software platform. This full-process supervision system of food production greatly reduces the probability of food safety accidents. Obtained 1 software copyright and 1 invention patent.
This project has obtained a total of 28 authorized invention patents and published 168 papers, of which 53 were included in SCI and 1 national standard material was formulated. The overall level has reached the domestic leading level.
The project technology and products as a whole have been industrialized in Shanghai Dean Medical Laboratory Co., Ltd. and Shanghai Huiyun Biotechnology Co., Ltd., and have been promoted and used in more than 100 large domestic enterprises including New Hope Liuhe, Yurun Group, Jinluo Group, Jiulian Group, Shengyuan Food, etc., breaking the monopoly of imported products and reducing the incidence of food safety accidents. From 2013 to 2015, the company's new output value was 60.9 million yuan, new profits were 12.13 million yuan, and new taxes were 1.46 million yuan, accounting for about 10% of the market share in this field.
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