Notice of the Ministry of Science and Technology on Issuing Guidelines for Application of Emergency Projects for Research and Development of New Coronavirus (2019-nCoV) On-site Rapid Detection Products
Guo Kefa Zi [2020] No. 28
All relevant units:
In accordance with the overall deployment of the State Council's scientific and technological work on the joint prevention and control mechanism for the pneumonia epidemic caused by novel coronavirus infection, and in accordance with the relevant requirements of the key special organization and management of the national key research and development plan "Public Security Risk Prevention and Control and Emergency Technical Equipment", the guidelines for the application of emergency projects for the prevention and control of the pneumonia epidemic caused by novel coronavirus infection are hereby issued. Please organize the project declaration according to the guidelines. The Ministry of Science and Technology will, in accordance with the special requirements for the prevention and control of the pneumonia epidemic caused by the new coronavirus infection, select the best projects and support them, and jointly organize and promote the implementation of the project with the Food and Drug Administration. The Medical Device Technical Review Center of the State Drug Administration will conduct a comprehensive evaluation of the products, and the China Food and Drug Control Institute will establish corresponding standards and conduct performance evaluation.
Relevant matters are notified as follows.
1. Project Requirements
1. The project should focus on the emergency needs of the new coronavirus (2019-nCoV) on-site rapid detection, highlight the result orientation, focus on the core goal of rapid diagnosis of suspected patients and on-site screening of people in close contact, clarify the research objectives and time nodes, and concentrate on tackling key problems.
2. If the project research involves human research, it shall pass the ethical review and sign the informed consent form in accordance with the regulations; if it involves the collection, collection, sale, export and exit of human genetic resources, it shall comply with the relevant provisions of the Interim Measures for the management of human genetic resources; if it involves experimental animals and animal experiments, it shall abide by the laws, regulations, technical standards and relevant provisions of the national experimental animal management, Use qualified experimental animals, animal experiments are conducted in qualified facilities to ensure that the experimental process is legal, the experimental results are true and effective, and pass the experimental animal welfare and ethical review.
3. The scientific data generated by the project shall be unconditionally submitted to the platform designated by the Ministry of Science and Technology on schedule, and shall be open to all scientific and technological workers and the public for sharing by all undertaking units of the project and even in the future.
4. The project lead unit that has obtained the project shall apply for the medical device registration certificate within half a month of the project approval and meet the acceptance requirements.
2、 Declaration requirements
1. The application unit shall organize the application in the form of a project according to the research content of the guide support direction, covering all the assessment indicators of the corresponding guide research direction, and the project may have a topic. The project should be declared as a whole and must cover all the assessment indicators in the corresponding guideline direction. The project application unit recommends a scientific researcher as the project leader, and each subject has a person in charge, and the project leader can serve as the person in charge of one of the subjects.
2. The project lead application unit and project participants shall be scientific research institutes, institutions of higher learning and enterprises registered in mainland China, with independent legal personality. State agencies may not take the lead or participate in the declaration.
3. The project lead application unit, project participating units and project team members are in good faith and have no record of serious dishonesty in scientific research and credit "blacklist" in relevant social fields during the disciplinary execution period.
4. The person in charge of the project (subject) shall have a senior professional title or doctor's degree, and shall be the person who puts forward the main research ideas of the project (subject) and the scientific and technical personnel who actually presides over the research. There are unlimited requirements for the project leader, no age and other requirements, as long as he has the ability and determination to contribute to winning the battle of epidemic prevention, prevention and control, he can participate in the declaration.
Public servants of the central and local state organs at all levels (including other personnel exercising the functions of science and technology plan management) shall not declare projects (topics).
5. After the application project is accepted, in principle, the application unit and the person in charge shall not be changed.
3、 Declaration method
1. Online reporting. The project application unit is requested to fill in the project application form online through the public service platform of the national science and technology management information system as required, and submit the project application form of about 3000 words. The project management professional institution will use the project application form filled in online as the basis for subsequent form review and project review. The format of the project declaration form can be downloaded in the relevant column of the public service platform of the national science and technology management information system.
The acceptance time for the project application unit to fill in the application form online is from 16:00 on February 8, 2020 to 16:00 on February 13, 2020.
National Science and Technology Management Information System Public Service Platform:
https://service.most.gov.cn
Technical consultation telephone: 010-58882999 (trunk line)
Technical Advisory Mailbox: program@istic.ac.cn
2. Submission of materials and business consultation. Please send each declaration form (paper, in duplicate) stamped with the official seal of the declaration unit to the professional organization before February 13, 2020 (subject to the time of mailing). The project application form shall be directly generated and printed through the national science and technology management information system.
Address: China Biotechnology Development Center, Building 4, No.16 Xisihuan Middle Road, Haidian District, Beijing 100039
Tel: 010-88225068
Attachment:
New coronavirus (2019-nCoV) field rapid detection product development emergency project declaration guide
Ministry of Science and Technology
February 8, 2020
(This matter is voluntarily disclosed)
Attachment:
New coronavirus (2019-nCoV) field rapid detection product development emergency project declaration guide
Since the outbreak of pneumonia infected by novel coronavirus (2019-nCoV), the rapid marketing and clinical application of common real-time quantitative fluorescent PCR nucleic acid detection reagents have played an important role in the clinical diagnosis of patients and the screening of suspected patients. However, due to the limitations of cumbersome operation, long time consumption and the need for centralized inspection, it still cannot meet the testing needs of a large number of suspected patients and asymptomatic infected people. The purpose of this guide is to widely solicit on-site rapid detection products for novel coronavirus (2019-nCoV), break through the restrictions of existing detection technology on personnel/places, shorten the detection time, improve the convenience, promote the diagnosis forward and downward, and realize the rapid diagnosis of suspected patients and on-site screening of people in close contact.
1. Nucleic acid field rapid detection equipment and reagents
The purpose of research and development: to provide on-site rapid detection means for patient diagnosis, to alleviate the current detection pressure of patient diagnosis.
Assessment indicators: nucleic acid extraction and amplification detection are integrated with a separate closed tube to realize on-site rapid detection of "sample in and result out" and solve the problem of "open cover". The detection time of the whole process is not more than 1.5 hours. The analytical sensitivity is less than 300 copies/ml. Compared with traditional real-time fluorescent PCR reagents, the detection rate (sensitivity) is not less than 95% and the specificity is not less than 99%, false negatives of detection due to variation can be encompassed.
Time node: complete product research and development within one week, provide products within two weeks for performance evaluation by a third party, and obtain a medical device registration certificate within one month.
Number of projects to be supported: no more than 2.
Relevant notes: The lead unit is an enterprise with a good research foundation and strong industrialization capabilities. It needs to jointly declare with medical institutions that can provide samples, encourage industry-university-research medical inspection cooperation, and provide real new coronavirus when applying for the project. The test results of pneumonia clinical specimens infected by the coronavirus.
2. Antigen rapid detection reagent
Research and development purpose: to provide a faster on-site detection method for the screening of suspected patients and asymptomatic infection without relying on equipment (place).
Assessment index: the whole process test duration shall not exceed 30 minutes. The detection rate of antigen reagents in clinical patients can reach more than 80% of nucleic acid detection, and there is no significant cross with the common coronavirus that infects people.
Time node: complete product research and development within two weeks, provide products within three weeks for performance evaluation by a third party, and obtain a medical device registration certificate within one and a half months.
Number of projects to be supported: no more than 3.
Relevant notes: The lead unit is an enterprise with a good research foundation and strong industrialization capabilities. It needs to jointly declare with medical institutions that can provide samples, encourage industry-university-research medical inspection cooperation, and provide real new coronavirus when applying for the project. The test results of pneumonia clinical specimens infected by the coronavirus.
3. Antibody rapid detection reagent
Purpose: To provide on-site rapid and high-throughput rapid testing of blood samples for the screening of suspected patients.
Assessment index: on-site rapid detection reagent can detect whole blood, and the whole process detection time is not more than 30 minutes. The detection rate of IgM antibody reagent was more than 70% in clinical patients, and the detection rate of IgG antibody/total antibody reagent was more than 90% in convalescent patients, and there was no significant cross with the serum of patients with common coronavirus infection.
Time node: complete product research and development within one week, provide products within two weeks for performance evaluation by a third party, and obtain a medical device registration certificate within one month.
Number of projects to be supported: no more than 5.
Relevant notes: The lead unit is an enterprise with a good research foundation and strong industrialization capabilities. It needs to jointly declare with medical institutions that can provide samples, encourage industry-university-research medical inspection cooperation, and provide real new coronavirus when applying for the project. The test results of pneumonia clinical specimens infected by the coronavirus. IgM and IgG antibody reagents can be declared either one or both.
