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.

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.