B · Normal
[Standardizing the detection of human disease susceptibility genes, two national standards for biochips were approved and released] On October 30, reporters learned today that the State Administration for Market Regulation approved the release of two new versions of national standards, "Basic Terminology of Biochips" and "Microarray Chip for Detection of Human Disease Susceptibility DNA Polymorphisms", which will be implemented from February 1, 2027. "Basic Terminology of Biochips", as the basic standard in the field of biochips, replaces the 2011 edition that had been implemented for more than ten years, and systematically reconstructs the industry concept system. The standard closely follows technological evolution and industrial needs, adding core terms such as nucleic acid detection chip, immune detection chip, and organ chip, and further improving the expression of basic definitions such as biochip, microarray chip, and microfluidic chip. The content covers four major sections: basic terminology, chip probes, microarray chip classification, and microfluidic chip classification. It comprehensively covers the mainstream product types in the current market. It will effectively eliminate conceptual ambiguities in technical exchanges and help academic research, industrial collaboration, and international docking.
"Human Disease Susceptibility DNA Polymorphism Detection Microarray Chip" focuses on disease susceptibility DNA polymorphism detection scenarios, clarifying that microarray chips can detect tens to tens of thousands of sites in parallel at a time, and puts forward five core requirements around full-process control. The standard mainly stipulates four aspects: First, it regulates the collection, storage, transportation and pre-processing requirements of blood, saliva, oral mucosa, tissue and other samples; second, it requires that the detection site must be verified by a Chinese population study of no less than 500 people; third, it stipulates that the site detection rate is not less than 99%, the accuracy and repetition rate are not less than 99.9%, and a negative and positive control is set; fourth, it requires the establishment of a site-related database, equipped with risk assessment software and the issuance of a standardized test report. Compared with the old version, the new version not only raises the threshold for site verification sample size, but also extends the scope of the specification from the technical requirements of a single product to the entire chain of testing samples, site verification, product application and service approval.
两项国家标准紧密配套、互为支撑,将有力规范人体疾病易感基因检测全过程,为生物芯片产品研发、质量评价、健康管理服务提供统一技术依据。 (央视新闻)
Comments