Clinical Laboratory Guidelines for Gene Amplification

Author: Zheng Huaijing
Publisher:
Publish Date: 2001-09-01
Features: With the rapid development of molecular biology, an increasing number of molecular biology techniques have been applied to clinical medicine. Polymerase Chain Reaction (PCR) technology is currently one of the most widely used molecular biology methods in China. Not only large and medium-sized hospitals in cities but also basic-level hospital laboratories in certain regions have extensively adopted PCR technology, conducting dozens of testing projects. Although theoretically, this technology could be used for the diagnosis of various diseases such as genetic disorders, infectious diseases, and tumors, this is only in its initial stages, and PCR technology still needs continuous improvement and maturation.
First, in terms of technology, the methods currently used in clinical laboratories in China are largely derived directly from research laboratories with minimal differences. However, these two types of laboratories differ significantly in both objective conditions and management and personnel quality, necessitating the development of PCR techniques adapted to hospital conditions. As introduced in this book, the FDA documents require that kits used for clinical diagnostic testing must be paired with probes to ensure the specificity of PCR detection, in addition to having reliable measures to prevent contamination.
Second, the clinical practical value of PCR needs further exploration. It cannot be said that PCR technology can currently replace classical microbiological methods and techniques. The FDA documents propose that to properly evaluate the clinical application value of PCR, it should be compared with classical microbiological methods, with the latter serving as the gold standard. Therefore, how to strengthen the management of PCR technology in hospital laboratories has become an important issue in the management of hospital laboratories in China. It is hoped that the publication of this book can make its due contribution in this regard.