Introduction
Outline
The Ministry of Education-approved Engineering Research Center of Medical Protection against Nuclear, Chemical and Biological Terror was established in December 2014, mainly based on Southern Medical University( the former First Military Medical University) ,the only university with the background of military medicine all over the country, together with Da An Gene Co., Ltd. in Sun Yat-sen University, Yi Rui Biotechnology Co., Ltd. in Shenzhen. Focusing on the general requirements of national anti-terrorism task, the goal of the center was to complete the construction of “One Institution, Two Bases and Three Realizations” . This center aims to become a research institution specializing in anti-nuclear, chemical and biological terror technology, develop into a research base undertaking major research projects and boasting a wealth of achievements as well as a training base cultivating high-level technicians and scientists in counter-terror technology. This center is also aiming at realizing transformation in scientific and technical achievements in anti-terror research, achieving high-tech industrialization and equipment marketization.
This center has carried out a series of research, development and production in medical protection against nuclear, chemical and biological terror. We have achieved good results in basic research and industrial research, and reached the goals preset in our application and set up a center integrating research, development and production. This center boasts solid theoretical foundation and mature technology platform and has been developing in a right track.
Research and Industrialization Focus
（1）Real-time Fluorescence Quantitative Polymerase Chain Reaction (RTFQ PCR) detection, Kit Development and their Industrialization projects
A method for Fluorescence Quantitative Polymerase Chain Reaction and its Kit developed by this center is patented in China with Patent Number of 99100669.0. This patent is awarded the first prize by provincial as well as national Intellectual Property Office. Key techniques cover the following：Clinical sample preparation, technique for automated extraction and purification of nucleic acid, Designing Primers and probes, optimization with Taq polymerase, optimizing Fluorescent PCR amplification, One-Step Optimization of RT-PCR amplification, single color or multicolor fluorescent probe labeling, Multicolor fluorescent PCR amplification Optimization, Pollution prevention technique for single-tube and single serving, Kits assembly and quality inspection techniques, etc. We have developed over thirty types of fluorescent PCR kits detecting bacillus anthracis, Yersinia pestis, Brucella, Tura Frances bacteria, Yellow fever virus, Eastern equine encephalitis virus, Western equine encephalitis virus, Venezuelan equine encephalitis virus, Ebola virus, Lassa fever virus, Marburg virus, smallpox virus, hepatitis B virus, SARS virus, high-risk human papillomavirus, etc., earning the title of Key Product at the provincial as well as national level. This project has realized industrialization, the total investment being 3 million yuan and the scale being 3,400,000 persons per year within three years.
（2）Production of Monoclonal Antibody, Immune colloidal gold rapid detection kit and its industrialization
The center, equipped with advanced facilities to carry out immune protection research, such as antibody engineering, new vaccines, molecular diagnostics, immunotherapy, has developed such techniques as protective antigen analysis, monoclonal antibodies and genetic engineering antibody preparation, design and evaluation of recombinant vaccine, design and evaluation of immunotherapeutic agents. Thirty-four types of monoclonal antibodies detected by Enzyme immunoassay (ELISA) have been developed to identify the presence of antibiotic residues, illegal additives and neurotoxin and other hazardous substances in dairy products or seafood.
We developed 41 types (67 kinds) of immune colloidal gold rapid test strip, whose sensitivity degree meets national detection range. Sensitivity degree of some products meets detection range postulated by EU. All products are valid for one year at 4 ℃.
（3）Nucleic acid dot blot hybridization and its industrialized
This center has designed several genotyping kits, including human papillomavirus (HPV) genotyping testing kit, voiding mycoplasma (UU) genotyping testing kit, β thalassemia genotyping testing kit, etc., which have been approved by China Biological Products Inspection Office and have been patented. Based on this, the center has initiated to design product testing kits applied in clinical HPV, HBV and HCV infection detection. Theoretically, wild-type and mutant probes in technique of PCR-Membrane Chip detection, could be designed for all mutation sites and be copied on the membrane chip, expanding the number of mutation detection points. In comparison with fluorescent PCR Kit, the technique of PCR-Membrane Chip detection boasts high coverage of detecting gene mutation, more detection sites and high detection rate.
（4）Laboratory Measure Technique of Toxic Chemicals and its industrialization
Laboratory measure techniques of toxic chemicals are widely used to measure eighty six items in the fields of food, environment, medicine, biological samples. Test reports issued by the center are with legal effect and are recognized in more than forty countries or regions, including the United States, Japan, EU. Measure covers the following items: measure and analysis of toxic chemicals, chemical contaminants; analysis of pesticide residue, such as organophosphate, organochlorine, pyrethroid in food; drug residues measure in meat, eggs, seafood; analysis of inorganic acid ion (Fluorine, chlorine, bromine, nitrate, nitrite, sulfate, phosphate, cyanide, etc.);determination of food additives (pigments, preservatives, etc.); analysis of vitamins and amino acids,etc.; analysis of harmful substances and prohibited chemicals in cosmetic (Sibutramine, atmosphere fenfluramine, mazindol, dehydroepiandrosterone, hydrochlorothiazide, norephedrine, chromium, mercury and other heavy metals). Environment Testing: water quality or pollutant analysis, etc.; drug metabolism and pharmacokinetics in new drug development and clinical pharmacology research; toxicants analysis(purity measure of toxicants, such as heroin, morphine, ketamine, methamphetamine and their content determination in blood, urine, tissue ), trace evidence(trace compound analysis, paints identification in cars or boats), determination of alcohol content in blood, analysis of rodenticide / pesticide poisoning, etc.
（5）Medical Devices and Portable Rapid detection device and their industrialization
The center has designed Fluorescent PCR Device(DA7600), Time-Resolved Fluoroimmunoassay (TRF) Analyzer(DR6608),Devices for Automated extraction of nucleic acid and for Automated hybridization of nucleic acid. Fluorescent PCR Device (DA7600), Time-Resolved Fluoroimmunoassay (TRF) Analyzer(DR6608) and Device for Automated Extraction of Nucleic Acid have obtained medical device license issued by SFDA. Device of Automated Hybridization of Nucleic Acid was registered and is under the process of inspection by SFDA. Real-time fluorescent detection device for nucleic acid amplification, having obtained Certificate for New and Practical Patent and Medical Device License, is under large-scale industrial production and sales.
Moreover, in order to realize the civil use of nuclear biochemistry emergency devices, the center independently develops over forty sets of portable testing kits or devices to deal with nuclear, chemical and biological emergency, covering first aid kit against chemical accidents, kit of rapid testing to ensure food safety, repellent with long-term effect, first aid kit for vectors-borne diseases; disinfectant and insecticide kit, in-site immunization and inoculation kit, laboratory sheet sterilizer, SAS PCR Bacteria sampler, portable sampling box for field water, portable sampling box for whole sets of food, portable sampling box for whole sets of soil, sampling and monitoring bag for superficial microorganism, devices for collecting superficial samples in air, deep water, food, soil under nuclear, chemical and biological emergency or collecting microbes, mosquitoes, fleas, ticks, rodents, etc.
（6）Prevention and treatment drugs against toxic chemicals and its industrialization
Prevention and treatment drugs against nerve poisoning, such as Eight Five Prevention Method, Eight Five First-Aid Method，Eight Five anti-Cyanide Needle, tablets against cyanide poisoning, drugs against Incapacitating toxic agents Colpitts, antidotes against mustard gas poisoning, antidotes against Lewisite(Arsenic compounds such as arsenic) poisoning， etc.
