Polymerase Chain Reaction (PCR) is the abbreviation of polymerase chain reaction (PCR), also known as gene amplification laboratory. It can be regarded as DNA replication outside the organism. It can amplify specific DNA fragments and quickly grasp the viral content in human or animal body. Its accuracy is as high as nanometer level. It is a molecular biological detection technology. In order to ensure that the daily operation of the laboratory meets the requirements of the Ministry of Health, to ensure the accuracy of test results, to ensure the safety of laboratory hygiene and to ensure the long-term stable operation of the laboratory, it is necessary to establish strict laboratory management system, to establish standardized operating procedures, and to establish a series of quality management documents.
After the construction of the PCR gene amplification laboratory is completed, the legal representative shall submit an application for technical acceptance to the National Clinical Laboratory Center. When applying, the following materials should be submitted: 1. Copies of Medical Institution Practice License; 2. Feasibility Study Report; 3. Medical and health resources in the location of the proposed Laboratory for clinical gene amplification testing, the basic situation of the institution, the need for clinical gene amplification testing and the prediction and analysis of the operation of the laboratory for clinical gene amplification; 4. Planning for clinical gene amplification; The layout of laboratory settings; 5. The test items, equipment conditions and relevant technical personnel data to be carried out in the proposed clinical gene amplification laboratory.
Medical institutions that need to carry out the construction of PCR testing laboratories can carry out their work only after they have passed the acceptance of the laboratory of the Clinical Laboratory Center of the Ministry of Health and obtained the certificate of qualification. Only hospitals at or above the second level can set up PCR laboratories, including specialized hospitals. The third-level hospitals are organized by the clinical laboratory center of the Ministry of Health (usually the director of the provincial clinical laboratory center), and the second-level hospitals are acceptance by the experts organized by the provincial clinical laboratory center (generally the director-level experts of the provincial medical institutions). According to the Basic Setting Standards of Clinical Gene Amplification Laboratory, the technical acceptance of the applied clinical gene amplification laboratory was carried out. After the acceptance is completed, the acceptance report shall be sent to the applicant organization within 20 days. There are generally three acceptance teams, one of which is the head of the contact group, the other is the director of the clinical laboratory center of other provinces or the expert in the hospital of our province. According to the regulations, the detection of PCR should be carried out by the laboratory of each hospital. If other departments, such as infectious department and dermatology department, request to carry out and apply for acceptance, they should be approved by the provincial clinical laboratory centers in advance. There are at least 2 operators in the PCR laboratory, and they have the qualification certificate of induction training for PCR. Medical equipment needed in the PCR laboratory need to obtain the registration license of relevant medical devices. The testing reagents need to obtain the new drug certificate and drug production number. Fluorescent quantitative PCR should not be used for more than five years. When acceptance of PCR laboratory certification, five unknown samples (generally HBV-DNA, which may be the external quality control products of the clinical laboratory center of the Ministry of Health in recent one or two years) are required to be tested by the accredited laboratory and printed reports as an important experimental basis for acceptance. It is generally required that the quantitative results of five specimens must be within the range, otherwise they will not be qualified.
The management system of PCR gene amplification laboratory can be formulated by referring to the following contents: 1. Laboratories entering the area must change their work clothes, wear special green work clothes, wear hats, masks and change special slippers. 2. The experimenter receives samples in the reagent preparation area and prepares reagents for the experiment. 3. The experimenter collects the specimens every day. After acceptance and registration, the specimens are sent to the specimen preparation area through the transfer window. 4. Place the reagent in the refrigerator after the reagent is disposed in the reagent preparation area. When necessary, the specimen preparation area is fed through the transfer window. 5. The daily samples and reagents should be registered and recorded. They should be written neatly and in detail. Record books, paper and pens with the label of this room should be used. 6. Put the waste into the garbage bags in our room, and someone will take the garbage out of the laboratory and hand it to the hospital for centralized treatment. 7. After the experiment, the experimental table should be wiped with chlorine-containing disinfectant and 75% ethanol. The ultraviolet lamp should be disinfected for 30 minutes. The usage of ultraviolet lamp, refrigerator, centrifuge and other instruments should be recorded.