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皇冠足球比分网:揭秘:病毒检测的这把上海“尺子”是如何诞生的?

时间:2020/3/23 22:00:27   作者:   来源:   阅读:0   评论:0
内容摘要:-The standard substance is equivalent to a "ruler" to measure the accuracy of the kit.Liu Gang, head of the biometric team of the ...
-The standard substance is equivalent to a "ruler" to measure the accuracy of the kit.

Liu Gang, head of the biometric team of the Institute of Chemistry of Shanghai Metrology, is the research and development personnel of this standard substance.  He told reporters that the so-called "standard substance" is like a "ruler" to measure viruses.

At present, more than 100 new coronavirus nucleic acid detection kits have been developed by various biomedical enterprises in the market.  With the standard "ruler", the detection laboratory can be helped to confirm the detection results of the kit, and the occurrence probability of "false negative" can be further reduced.

Liu Gang said that before this, the Chinese Institute of Metrology had developed standard substances and Shanghai's "ruler" had also been compared with them.  There is no standard substance, the production enterprises mainly use ultraviolet spectrophotometer to detect the kit, while using the new coronavirus RNA standard substance, the sensitivity is 10 orders of magnitude higher.

Obtaining emergency approval meets the traceability requirement for RNA PCR detection of new coronavirus.  Xu Lai, deputy director of Shanghai Municipal Market Supervision Bureau, explained that the standard substance is like a "biological standard ruler", which can improve the accuracy and uniformity of virus nucleic acid detection.  In the past, nucleic acid testing for epidemic situations has gone through a "yes or no" phase of "yes or no" kits and boxes.  Now that you have standard substances, you can improve on the "no" level.

-Approval was changed from "series connection" to "parallel connection", greatly shortening the time.

Just as standard measuring tools are needed for length, weight, time, etc., so do creatures, but there is also a high threshold for "measuring" creatures.  At the beginning of February, the research and development team began to develop this standard substance, which also benefited from Shanghai's previous technological reserves.

Liu Gang said that researchers have been working overtime in the development. In addition, many reagent kit companies such as Zhijiang and Jinuo in Shanghai, and many analytical chemistry scientists have done a lot of basic work. In coordination with the green channel of the regulatory authorities, many parties have worked together to speed up the whole standard substance development process.

This project was highly valued and strongly supported by the Shanghai Municipal Science and Technology Commission and was included in the special emergency support plan for the new crown virus.  In addition, the approval process has been greatly innovated.

In the past, it usually took one and a half to two years for a national standard substance to be approved and certified by the State Administration of Market Supervision.  Now, the State Administration of Market Supervision and Management has opened a green approval channel for innovative evaluation in the first time, completing the whole process from the initiation of research and development to the special approval of national standard substances within 2 months.

"The original three main links, research and development, stability monitoring and approval, are linked in series, but now they are changed to parallel. Stability monitoring and approval are carried out simultaneously."  Xu Lai said that the Shanghai Municipal Market Supervision Bureau has set up a special working group to actively coordinate relevant departments to accelerate the development of relevant reference materials.  After the completion of the research work, the relevant application was immediately sent to the State Administration of Market Supervision and finally approved.

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