[Challenges and considerations on quality control and evaluation of pathogen metagenomic next-generation sequencing].

Metagenomic next-generation sequencing (mNGS) could be used for pathogen detection from nearly all types of clinical samples. Especially, the unique diagnostic capability of pathogen mNGS detecting unknown causative agent of infectious diseases makes this method become an importation complement and irreplaceable component for conventional routine laboratory test. However, the complexity of the testing process, the rapid product update, and the insufficiency in quality control and evaluation methods that all make clinical transformation, industry development, and regulation of this technology full of challenge and uncertainty. This review briefly introduces the technical advantages and challenges, and describes the general workflow and quality control steps in details. Finally, it focuses on current considerations regarding quality evaluation methods and standards for pathogen mNGS.

Challenges and considerations on quality control and evaluation of pathogen metagenomic next-generation sequencing / 生物工程学报

Metagenomic next-generation sequencing (mNGS) could be used for pathogen detection from nearly all types of clinical samples. Especially, the unique diagnostic capability of pathogen mNGS detecting unknown causative agent of infectious diseases makes this method become an importation complement and irreplaceable component for conventional routine laboratory test. However, the complexity of the testing process, the rapid product update, and the insufficiency in quality control and evaluation methods that all make clinical transformation, industry development, and regulation of this technology full of challenge and uncertainty. This review briefly introduces the technical advantages and challenges, and describes the general workflow and quality control steps in details. Finally, it focuses on current considerations regarding quality evaluation methods and standards for pathogen mNGS.

Quality control and evaluation of vaccines in China.

I was born in Luoyang in 1963, a city in China with thousands of years' history. The city is the eastern starting point of the Silk Road (BC 206-260 AD), a famous and long trade route in human history. Living in this ancient city, I grew up under the influence and impact of Chinese traditional culture. When I was a teenager, I once read a book "Yellow Emperor's Inner Canon" (Huang Di Nei Jing, written about 5th century BC), which is the oldest extant classic of traditional Chinese medicine. I was immediately attracted by an idea in it "prevention is better than cure," which is mean that the highest level of medical treatment is not to cure a disease, but to prevent the occurrence of diseases. I think even in the modern society, this is still the highest realm of medical treatment. Inspired by this view, I developed a strong interest in preventive medicine and majored in it during my college years. With an increasingly deeper understanding of preventive medicine, I gradually realized the importance of epidemiology and vaccinology in preventing infectious diseases. Fortunately, in 1991 I entered the group of professor Zhuang Hui in Peking University Health Science Center for a doctorate degree in epidemiology. Professor Zhuang who is an academician of the Chinese Academy of Engineering not only taught me how to do research, but showed me how to act like a scientist. I benefited greatly from his rigorous attitudes toward life and research. During this period, I focused on transmission routes of hepatitis C virus which made me increasingly recognized the great harm of hepatitis in China. It is well known that more than three-quarters of all liver cancer cases are thought to be attributable to hepatitis B or C. In China about 110 000 people die from liver cancer each year, accounting 45% of the total number of deaths caused by liver cancer worldwide.

Approach to matter-element analysis method for quality evaluation of Chinese materia medica based on spectrum-activity relationship / 中草药

To propose a new pattern for quality control and evaluation of Chinese materia medica(CMM).The limitation of quality control pattern for CMM was investigated and a new method for quality evaluation has been explored and designed,combining with the introduction on the conception of matter-element evaluation model and its application to product quality evaluation in value engineering,as well as the research survey on the spectrum-activity relationship of CMM.The new method for quality evaluation referred to the results of research concerning the spectrum-activity relationship of CMM.Taking the quality grade,quality index,and chemical composition of CMM as matter-elements,the evaluated grades and tested data were normalized to establish the matter-element model.With the establishment of the improved quality control method,which is in accordance with the basic characteristics of CMM,it is expected that the safety,efficiency,and quality stability of CMM could be ensured and a new scientific research strategy and technological support could be provided to promote the modernization of CMM.