Around the 2020 Chinese New Year, a sudden pneumonia epidemic raged across the land of China. Due to the impact of the novel coronavirus pneumonia epidemic, in January 2020, many units across the country successively issued notices on the extension of the equipment bidding project on the Chinese Government Procurement Network. However, hospitals, CDCs and other anti-epidemic front-line units continue to publish epidemic prevention and control The tender notice for the purchase of medical equipment such as emergency medical equipment, protective equipment and information equipment.
At present, the gold standard for diagnosis of the new coronavirus is to find certain specific nucleic acid sequences in the gene in patients. The real-time fluorescent RT-PCR method is commonly used in clinical laboratories and disease control laboratories. This detection method is mature and reliable. It is widely used in routine inspections and scientific research experiments, so it is not difficult to see that in the purchase details of equipment such as hospitals and CDCs this month, it can be seen that the purchase demand for PCR machines and nucleic acid extractors has increased significantly.
In addition, the editor of the Instrument Information Network also noticed in the various procurement information in January that in the procurement lists of many hospitals and CDCs, another type of equipment has also appeared in the procurement lists of hospitals many times. , That is, the microbial mass spectrometry detection system. This technology is mainly used in the medical field for component sequence analysis, structure analysis, molecular weight determination and the content determination of each component in the organism. Common biological mass spectrometry technologies are: MALD-TOF technology (matrix Assisted laser analysis ionization time-of-flight mass spectrometry), electrospray ionization tandem mass spectrometry (ESI-MS/MS) and electrospray quadrupole time-of-flight mass spectrometry (ESI-QTOF).
Clinical microbiological testing plays an indispensable role in the diagnosis of infectious diseases, medication guidance, hospital infection control, and antibacterial drug management. The MALDI-TOF technology came out in the late 1980s and developed rapidly. It has revolutionized the traditional mass spectrometry technology, which is mainly used for the research of small molecules. It not only ushered in a new era of technological development, but also The medical and biological fields, especially the field of clinical microbiological testing, have brought revolution. In addition to the identification of cultured and isolated microorganisms, in recent years, the application of MALDI-TOF in the field of clinical biology has also been continuously expanded, including direct identification of pathogens in clinical specimens, detection of bacterial sensitivity to drugs, and analysis of pathogenic bacteria. Types of research, so that it has broad application prospects in the field of clinical medicine.
Protein fingerprinting technology is a new technology with the rise of proteomics. In recent years, more and more scholars have studied microorganisms at the protein level. Proteins are the performers of bacterial functions. In 1996, Clayin and others used MALDI-TOF to successfully identify The use of gram-negative bacteria indicates that bacteria of different genera and species have different protein fingerprints. The bacteria can be quickly identified based on the bacterial protein fingerprints. Researcher Tang Hong from the Institute of Microbiology, Chinese Academy of Sciences and others used the latest technology and detection methods of "Protein Mass Spectrometry Fingerprinting" to analyze the changes of protein components in the serum of SARS and non-SARS patients. This method of detecting SARS virus has been clinically confirmed by Beijing Tiantan Hospital. The positive rate is close to 95%, and the specificity is close to 96%. The test result can be obtained on the first day of fever.
In addition, to be applied in the field of clinical medicine, mass spectrometry manufacturers need to apply for medical device certification through the State Food and Drug Administration. (Click "Read the original text" at the end of the article to learn about the products and manufacturers of mass spectrometry instruments approved by NMPA in the Chinese market and within the validity period) Currently, there are 9 MALDI-TOF manufacturers that sell in the Chinese market and obtain medical device licenses (within the validity period). Imported manufacturers include French Mérieux and Brook, while domestic manufacturers include Zhuhai Meihua, Darui Biotech, Incentive, Serdi Bio, Yicheng Moody (Rongzhi Bio), Tianrui Instruments, Antu Biotech. It can be seen that the number of domestic MALDI-TOF manufacturers in the Chinese market has exceeded the number of imported manufacturers. During the period of fighting the epidemic, the instrument information network found in the procurement of medical equipment procurement projects that major units such as hospitals purchased the equipment. Still prefer imported instruments.