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Progress the digital PCR biochip reader developed by an Guang Institute has obtained the medical device registration certificate

Recently, the”digital PCR biochip reader” developed by the team of researcher Liu Yong and researcher Zhu Ling of an Guang Institute has officially obtained the class II medical device registration certificate (wzz 20222220135) from Anhui drug administration. The product model is dcscanner-100. This is the first digital PCR product approved for listing in Anhui Province, filling the gap of independent digital PCR products in Anhui Province. The instrument obtained the medical device registration certificate, which laid the foundation for the next clinical application.

Digital PCR biochip readerDCScanner-100

Digital PCR (dpcr) is the third generation of PCR technology. It is an absolute quantitative technology of nucleic acid molecules. Compared with the previous generation of qPCR technology, digital PCR can directly count the number of DNA molecules, which is the absolute quantification of the starting sample. It is completely independent of reference and standard curve, and has extremely high sensitivity and resolution. It is a new trend in the application and development of nucleic acid detection industry in the future. The biochip reader approved this time can be adapted to the micro cavity and micro droplet digital PCR chip independently developed by Anguang Institute, and is widely used in tumor liquid biopsy, non-invasive prenatal diagnosis, accurate quantification of viral nucleic acid load and other fields.

Since 2011, the research team of the optoelectronic center of the Institute has focused on the research of innovative technologies in the field of molecular diagnosis, and has continued to tackle key problems in microfluidic chips, optoelectronic integrated detection, and core reagents for molecular diagnosis. With the strong support of the National Natural Science Foundation of China, the STS key project of the Chinese Academy of Sciences, the youth Promotion Association of the Chinese Academy of Sciences, major science and technology projects of Anhui Province, the research team has used the developed digital PCR technology platform, Important research achievements have been made in the detection of circulating miRNA markers in hepatocellular carcinoma and the quantification of nucleic acid load of chronic hepatitis B virus.

For a long time, the research team of the optoelectronics center of the Institute has always adhered to the clinical demand as the guide, with the research and development of advanced medical optical diagnosis and treatment technology and innovative equipment as its own responsibility, focused on breaking through the”neck” technical bottleneck, and worked hard to achieve the goal of localization of high-end medical devices.