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China Will Build More PCR Testing Laboratories

Aug 06, 2020

National Health Office Science and Education Letter (2020) No. 534


Health Commission of all provinces, autonomous regions, municipalities directly under the Central Government and Xinjiang Production and Construction Corps:



In order to implement the requirements of the "Guiding Opinions of the State Council on the Normalization of Prevention and Control of the New Coronary Pneumonia Epidemic of the New Coronavirus Pneumonia Epidemic Prevention and Control Mechanism" (Guo Fa Dian [2020] No. 14, hereinafter referred to as the "Guiding Opinions"), ensure Laboratory biosafety during the epidemic prevention and control period to prevent secondary disasters, the following requirements are now put forward for the supervision and management of laboratory biosafety:


1. Strictly implement the management requirements for experimental activities of the new coronavirus


According to information on the transmission characteristics, pathogenicity and clinical data of the new coronavirus (hereinafter referred to as the new coronavirus), the virus is managed in accordance with the second category of pathogenic microorganisms. Local health and health administrative departments should require biosafety laboratories to carry out relevant experimental activities in strict accordance with the protection requirements: new coronavirus cultivation and animal infection experiments should be carried out in biosafety level 3 or above laboratories; the operation of uncultured infectious materials should be carried out in Biosafety level two and above laboratories, and at the same time, use personal protection not lower than biosafety level three laboratories; the operation of inactivated materials should be carried out in biosafety level two and above laboratories; no operations involving infectious materials, It can be performed in a biosafety first-level laboratory.


2. Do a good job in laboratory biosafety service guarantee and standardized management


Local health and health administrative departments should do a good job in the filing and management of testing laboratories, compact the main responsibility of the laboratory establishment unit, supervise relevant units to strengthen training and assessment in experimental operation technology, personal protection, test sample disposal, etc., and standardize laboratory personnel for the new crown virus Sample testing operation process, improve testing capabilities, and ensure the safety of testing personnel and the surrounding environment.


3. Strengthen the management of new coronavirus strains and related samples


Local health administrative departments must strictly manage the new coronavirus strains and related samples in accordance with laws and regulations to ensure safety.


(1) Transportation of new coronavirus strains and samples. The transportation of new coronavirus strains and potentially infectious materials shall be managed in accordance with the "Administrative Regulations on the Transportation of Highly Pathogenic Microorganisms (Virus) Species or Samples that Can Infect Humans". According to the needs of the epidemic prevention and control situation, in the transportation link, the inspection samples of the "should be inspected" personnel are strictly managed in accordance with the samples of highly pathogenic pathogenic microorganisms; the inspection samples of the "willing to inspect" personnel shall be transported out of the unit through the samples After the biosafety expert committee conducts a risk assessment, it can be managed according to ordinary samples. The scope of personnel for "should be checked" and "willing to check" shall be implemented in accordance with the "Guiding Opinions". All provincial health administrative departments should strengthen the supervision and management of virus strains and related sample storage units, and strictly prevent and eliminate the occurrence of unauthorized transportation without approval.


(2) Disposal of relevant samples. Provincial-level health and health administrative departments shall, in accordance with the needs of epidemic prevention and control and laboratory biosafety related requirements, promptly research and judge and put forward opinions on the disposal of biological samples tested by the new coronavirus laboratory. For those that really need to be preserved, they should designate an institution with preservation conditions to preserve them as soon as possible in accordance with the principle of relative concentration, or send them to the national-level bacteria (virus) collection center for preservation; for those that do not need to be preserved, the relevant institutions shall promptly deal with them in accordance with relevant biosafety requirements .


(3) Isolation and preservation of virus strains. Provincial health administrative departments are requested to urge high-level biosafety laboratories in their jurisdictions to report the isolation and sharing of new coronavirus strains to the Department of Science and Education of the Commission in a timely manner, and to guide laboratories within 90 days after isolation of the new coronavirus strain , Apply to the National Bacteria (Virus) Collection Center for preservation, and promptly send the new crown virus strain to the preservation institution for preservation after completing the relevant experimental activities. All provincial-level health administrative departments are requested to handle the approval procedures for relevant laboratories and bacteria (virus) species preservation institutions at all levels to provide new coronavirus strains or vaccine strains with new coronavirus as the parent virus to other laboratories or outside units. At the time, timely provide the copy of the transportation permit to the Science and Education Department of the Commission.


Fourth, strengthen laboratory biosafety supervision


Provincial health and health administrative departments must effectively strengthen organization and leadership, improve laboratory biosafety supervision capabilities, carry out laboratory biosafety supervision work in accordance with the principles of localization, classification and classification, strengthen supervision and inspection of new coronavirus experimental activities, and guide relevant institutions in their jurisdictions Strengthen biosafety management, carry out experimental activities in strict accordance with the "Regulations on Biosafety Management of Pathogenic Microorganism Laboratories" and relevant technical specifications to prevent laboratory leaks or personnel infections, and ensure laboratory biosafety.