The establishment of a PCR laboratory has very high requirements. The following five conditions should be met for the development of a PCR laboratory:
1. Must have a standard PCR fluorescence laboratory;
Real-time fluorescent quantitative PCR technology was launched in 1996 by the American company Applied Biosystems
Because this technology not only realizes the leap from qualitative to quantitative PCR, but also has the characteristics of stronger specificity, effective solution to PCR contamination problems, and a high degree of automation compared with conventional PCR and has been widely used. This paper attempts to introduce its quantitative principles, methods, and reference issues.
2. The detection equipment must meet the requirements of standard PCR fluorescence laboratory settings;
Fluorescence quantitative PCR instrument + real-time fluorescent quantitative reagent + general computer + automatic analysis software constitute a PCR-DNA/RNA real-time fluorescent quantitative detection system.
3. Must pass the acceptance and certification of the National Clinical Inspection Center;
4. The testing personnel must pass the business training of the National Clinical Inspection Center and obtain a certificate of conformity;
The staff in the PCR laboratory must participate in the clinical gene amplification training courses organized by the Ministry of Health or the provincial clinical testing centers, and work with certificates. The PCR laboratory has passed the acceptance, and at least two laboratories must hold the "Clinical Genetic Testing Employment Certificate". The PCR laboratory must establish a strict laboratory management system, establish standardized operating procedures (SOP), and establish a series of quality management documents, etc., to ensure that the daily operation of the laboratory meets the requirements of the Ministry of Health, to ensure accurate test results, and to ensure laboratory hygiene and safety. Ensure long-term stable operation of the laboratory
5. It must be operated in a sterile and dust-free environment (meaning that there are cleanliness requirements, but there are no strict cleanliness regulations)