China News Service, June 3, according to the National Health and Welfare Committee website, the State Council responded to the new coronavirus pneumonia joint prevention and control mechanism medical treatment team recently issued a notice requesting the expansion of the new coronavirus nucleic acid detection range, while doing a good job of nucleic acid detection quality control , So that the nucleic acid detection can guarantee both "quantity" and "quality".
Data map: A vehicle driver is waiting for nucleic acid detection. Photo by Yin Liqin
In order to implement the requirements of the “Guiding Opinions of the State Council on the Joint Prevention and Control Mechanism for New Coronavirus Infection Pneumonia Outbreaks to Do a Good Job in the Normalization of New Coronary Pneumonia Outbreaks” (Guo Diandian [2020] No. 14), expand the detection range of new coronavirus nucleic acid For the quality of nucleic acid testing, the State Council should respond to the medical treatment team of the new coronavirus pneumonia joint prevention and control mechanism and issued the "Notice on Doing a Good Job in the Quality Control of New Coronavirus Nucleic Acid Testing under Normalized Prevention and Control of the Epidemic Situation" (hereinafter referred to as the "Notice").
The "Notice" sets forth specific requirements for the quality control of nucleic acid detection of new coronavirus from four aspects:
1. Attach great importance to the quality control of nucleic acid detection
At present, the national epidemic prevention and control has entered the normal stage, which puts forward higher requirements for nucleic acid detection capabilities. In accordance with the expansion of the scope of nucleic acid testing, the requirement for thorough inspection of key populations and the willingness of other populations to be inspected is required. Local governments have focused on strengthening the construction of nucleic acid detection capacity, with a significant increase in nucleic acid detection volume and a significant increase in efficiency. While ensuring the increase in the amount of nucleic acid detection, quality control must be strengthened to ensure accurate and reliable detection results. All localities should attach great importance to the quality control of nucleic acid detection, so that the nucleic acid detection can guarantee both "quantity" and "quality", and provide strong technical support for the prevention and control of normal epidemic situations.
Second, strengthen laboratory filing or access management
Laboratories carrying out nucleic acid testing shall comply with the "Regulations on the Biosafety Management of Pathogenic Microbiology Laboratories" (State Council Order No. 424) and "Administrative Measures for Clinical Gene Amplification Testing Laboratories in Medical Institutions" (Health Office Medical Administration [2010] 194 No.) relevant regulations, and be registered in the corresponding health administrative department, with the laboratory conditions of biosafety level 2 and above and PCR laboratory conditions. Medical testing laboratories (often referred to as third-party laboratories) should also meet requirements such as "Basic Standards for Medical Testing Laboratories (Trial)" and "Management Standards for Medical Testing Laboratories (Trial)".
3. Strengthen laboratory testing quality control
All localities should strengthen the quality control of nucleic acid testing, and integrate medical institutions (including medical testing laboratories, the same below) and laboratory of disease control institutions that carry out nucleic acid testing into the quality control system. The laboratory should do daily indoor quality control, and normally accept national or provincial inspection quality control. Provincial health administrative departments should strengthen the daily quality control of nucleic acid testing laboratories, and organize laboratories to participate in inter-room quality assessment in batches to ensure that each laboratory participates in at least one inter-room quality assessment in the short term and passes the test. Nucleic acid testing shall not be carried out if the quality of the test results is outstanding, or if the room quality assessment fails.
4. Strengthen the training of nucleic acid testing personnel
All localities should strengthen the technical training and guidance of nucleic acid testing related personnel in medical institutions and disease control institutions in accordance with the requirements of the "New Coronavirus Pneumonia Laboratory Testing Technology Guide", covering the collection, storage, transportation, processing and testing of specimens. Limit the factors that produce false negatives. For key links such as specimen collection and processing, intensify staff training to ensure that sampling personnel collect all types of specimens in a standardized manner, and laboratory testing personnel must be proficient in specimen processing and testing methods, and carry out biological safety protection when conducting testing.