New product | The first digital PCR-based novel coronavirus test reagents received Class III medical device registration certificate!

release date：2022-01-16

New Product

With the approach of Chinese New Year, the epidemic is spreading in many places in China, and the arrival of Omicron, the situation of epidemic prevention and control is serious and complicated.

Omicron mutant strains have ravaged many countries around the world, with many mutation loci and fast transmission. Although the symptoms are relatively mild, it is not easy to be detected. At this time, the sensitivity of nucleic acid detection reagents, especially the ability to effectively detect weakly positive samples, becomes particularly important.

TargetingOne Technology (Beijing) Corporation(hereinafter referred to as "TargetingOne") announced that its self-developed "SARS-COV-2 Nucleic Acid Detection Kits(Fluorescent PCR Method)" was officially approved by the State Drug Administration (NMPA) for medical devices. (NMPA Note Approval: 20223400015). This is the first NMPA approval for a novel coronavirus test based on digital PCR technology, and the first product in the world to be officially approved after review for the use of digital PCR technology in the field of infectious diseases. This means that this new technology is independently controllable and further mature.

It is reported that the product is jointly developed by TargetingOne and Tsinghua University and a number of hospitals and CDC, etc., and manufactured by TargetingOne.

Digital PCR, known as the "third generation PCR technology", has improved the sensitivity and accuracy of nucleic acid detection. Unlike fluorescent PCR, digital PCR does not require standards and uses microfluidics to split the PCR reaction system into tens of thousands of microdroplets to obtain the number of target nucleic acid molecules directly through single-molecule amplification.

It is reported that the product has significant advantages for low load viral nucleic acid detection, with a sensitivity of up to 100 copies/mL, effectively improving the sensitivity of detection and greatly reducing positive leakage. The product will not miss or off-target for the 15 mutant strains commonly found worldwide: Delta strain, Omicron strain, etc., providing a more accurate tool for global novel coronavirus epidemic prevention and control and nucleic acid detection.

◎ Application Areas:

● For the detection of CDC Closely exposed people;

● For the detection of customs isolation medical observation population

● For the testing of suspected cases;

● For pharmacological studies and clinical evaluation of anti-novel coronavirus drugs；

◎ Product advantages:

● High sensitivity: the lowest lower limit of detection is 100 copies/mL;

● Simple operation: one-step sample loading with low human error;

● Closed testing: prevent aerosol contamination and sample loss, and prevent false positives;

● Good specificity: no cross-reactivity with other common respiratory pathogens (viruses, bacteria, fungi).

Professor Wang Guangzhi, Head of the Department of Biomedical Engineering at Tsinghua University School of Medicine, said:

“

Digital PCR technology is the latest advancement in the field of PCR. Through the combination of PCR and microfluidics, the performance of PCR can be greatly enhanced, including the quantitative capability, sensitivity of detection, wide applications in both biomedical and industrial fields. Through the independent research and development, Guo Yong's team has solved key problems successfully in this field, promoted the domestication of digital PCR technology, made an important contribution to the independent and controllable of digital PCR technology. We are very pleased to see the approval of the novel coronavirus digital PCR product, which provides a new tool for the anti-epidemic, it is also expected to play an important role in the diagnosis of novel coronavirus, clinical treatment and new drug development.

”

Zhang Fujie, Director of the Infection Clinical and Research Centre at Beijing Ditan Hospital, Capital Medical University, said:

“

Our research team has achieved excellent results for the clinical evaluation of novelcoronavirus-neutralizing antibody and small molecule drugs in patients by using digital PCR technology. The advantages of this highly sensitive assay are not only in the clinical evaluation of antiviral drug for Covid-19, but also in the treatment of other viral diseases such as HIV and viral hepatitis.

”

Ma Xuejun, Director of Central Laboratory of National Institute of Viral Disease Control and Prevention, said:

“

At present, the domestic novel coronavirus epidemic prevention and control is effective, as the foreign epidemic is getting more and more serious, external prevention of imports, the pressure of internal prevention and rebound of the domestic novel coronavirus prevention and control is increasing. qPCR nucleic acid detection is the recognized gold standard for novel coronavirus detection, but there are still urgent problems such as single gene positive, grey area samples (Ct 37-40). In the practical prevention and control process, qPCR cannot meet 100% of the prevention and control needs, especially the assay of People and frozen goods coming from key regional countries show a lot of more ambiguous results, and digital PCR technology just makes up for this application scenario, digital PCR can be accurate in some key regions and sites.

”

Dr. Wenjun Yang of TargetingOne said:

“

The official approval by the State Drug Administration of the npvel coronavirus nucleic acid detection reagent product is very important for TargetingOne, validating the rigour of our R&D, production and quality processes as well as clinical utility. We look forward to working with our partners to play a greater role in the prevention and control of epidemics with this product.

”

Up to now, the product has been selected as the research evaluation method for the clinical trials of four new anti-NeoCrown drugs and the research use method for two vaccines, and a total of 10 academic papers related to the research on the prevention and control mechanism of novel coronavirus have been published in JAMA, Clinical Infectious Diseases and other well-known journals by TargetingOne and partner institutions.

As the first domestic manufacturer of digital PCR instruments and reagents with full independent intellectual property rights, TargetingOne has broken the foreign monopoly in the field of digital PCR and gained a leading position in the international arena, demonstrating to the world the hardcore technological strength of China's intellectual manufacturing.