Drastically reduce positive missed tests! Another domestic nucleic acid kit was approved for marketing

Covid-19 testing adds to the good news. Recently, Beijing Xinyi Biotechnology Co., Ltd. (hereinafter referred to as "Xinyi Biotechnology") announced that its self-developed "Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (Fluorescent PCR Method)" has officially obtained the approval of the State Drug Administration (NMPA) for medical devices. It is reported that it is jointly developed by Xinyi Biology and Tsinghua University and a number of hospitals and CDCs, and produced by Xinyi Manufacturing Technology (Beijing) Co., Ltd., a wholly-owned subsidiary of Xinyi Biologics.

The reporter learned that this is the approval of the first new crown detection reagent based on digital PCR technology of the State Drug Administration, and it is also the world's first test product that has been officially approved after review to apply digital PCR technology to the field of infectious diseases. This means that this new technology is autonomously controllable and further matured.

Kit Digitization Displays COVID-19 data

Digital PCR technology, known as "third-generation PCR technology," improves the sensitivity and accuracy of nucleic acid testing. Xinyi Bio said that the kit has significant advantages for low-load viral nucleic acid detection, with a sensitivity of up to 100 copies/mL, which effectively improves the detection sensitivity and greatly reduces the positive missed test.

Founded in 2015 and located in Zhongguancun Science and Technology Park, Xinyi Biotech is a national high-tech enterprise and a "specialized and specialized" enterprise in Beijing, focusing on the independent innovation of molecular diagnostic technology and the application and transformation of major diseases, and has a high-level R&D team in the fields of instruments, chips, materials, reagents, software and other fields.

Professor Guo Yong of Tsinghua University School of Medicine is one of the developers of the kit. He explained that with the help of microfluidic biochips, the digital display of new crown virus data has greatly improved the "signal-to-noise ratio" of nucleic acid testing. "For example, the TV sets in the older generation often have 'snowflakes', and the image quality is not high in fuzzy stability, but this situation does not exist in the current LCD TV, because the LCD TV signal is a digital signal instead of the previous analog signal." Digital PCR can improve the sensitivity and accuracy of nucleic acid testing, which is similar. ”

It is worth mentioning that the advantages of digital PCR technology in high sensitivity detection are not only reflected in the clinical effect evaluation of anti-new coronavirus drugs, but also in the detection of other viral diseases such as AIDS and viral hepatitis, which have very wide application prospects. Zhang Fujie, director of the Infection Clinical and Research Center of Beijing Ditan Hospital affiliated to Capital Medical University, said: "Our research team has used digital PCR technology to evaluate the efficacy of clinical patients with neutralizing antibodies and small molecule drugs of the new coronavirus, and achieved very good results. ”

Increased sensitivity significantly reduces positive missed tests

Xinyi Bio said that the kit has significant advantages for low-load viral nucleic acid detection, with a sensitivity of up to 100 copies/mL, which effectively improves the detection sensitivity and greatly reduces the positive missed test.

Guo Yong said that compared with the current commonly used fluorescence quantitative PCR, digital PCR technology has two significant advantages. "The technology can accurately detect the number of viruses without the need for standards. In layman's terms, current nucleic acid testing technology can only tell you whether the result is positive or negative, and through digital PCR technology, we can not only detect negative and negative results, but also know how many viruses are in the samples taken by positive patients. ”

"In this way, in medical research, we can monitor the treatment effect in real time when diagnosing and clinically treating covid-19 patients, and we can also clinically evaluate the effect of newly developed anti-COVID-19 drugs and vaccines." Guo Yong revealed that the new crown antibody drug led by Professor Zhang Linqi of Tsinghua University School of Medicine, which was recently approved for listing, also used this kit in the clinical research process.

At the same time, the kit can be single-molecule amplified, which is conducive to the detection of low-load viruses. "There have been many cases of isolation for 14 days that have been nucleic acid negative but tested positive after lifting isolation, and the high sensitivity of digital PCR technology makes this kit able to detect trace viruses in samples, which plays a vital role in excluding suspected cases, close contact cases, determining whether to lift isolation, reducing missed tests and false negative samples, and when faced with the blurred determination of fluorescence quantitative PCR methods for microviral samples, digital PCR methods may have a final word." Guo Yong said.

Prevent the new coronavirus variant from missing detection and off-target

With the complexity of the global pandemic and the emergence of new coronavirus variants, can this kit be effectively responded to? In this regard, Xinyi Bio said that the kit will not miss detection and off-target for the 15 common variant strains around the world: Delta strain, Omicron strain, etc., providing a more accurate tool for the prevention and control of the global new crown epidemic and nucleic acid detection.

The reporter noted that the kit said that its sensitivity can reach 100 copies/mL, what kind of concept is this? In this regard, Guo Yong explained that the smaller the value of the copy, the better the sensitivity. "The sensitivity of the current dual-target product is basically 200-500 copies/mL, and the test kit approved this time is 100 copies/mL, and it is a dual-target detection, which greatly improves the sensitivity of the new crown virus nucleic acid detection and can detect the results of 100 samples per milliliter."

Guo Yong said that the approval of this kit for listing on the one hand means that digital PCR technology is localized and independently controllable. The previous digital PCR technology in the world was mainly based on biomedical research applications, and the approved product is the first time in the world that this technology has been applied to the new crown field and officially moved to the clinic. On the other hand, for the entire technical field, the official approval of the new crown nucleic acid detection reagent based on digital PCR technology can promote the update and iteration and rapid progress of this technology, marking a new starting point for digital PCR technology, which will play an increasingly important role in the prevention and treatment of major human diseases.

Dr. Yang Wenjun of Xinyi Biology also said that the new crown virus nucleic acid detection reagent product was officially approved by the State Food and Drug Administration, which is an important milestone for Xinyi Biology, which verifies the rigor of the company's research and development, production and quality process and the clinical practicality of the product. "Xinyi Bio looks forward to extensive cooperation with partners to make this product play a greater role in epidemic prevention and control."