Sophonix’s COVID-19 Antibody Detection Kit Has Been Authorized by The FDA for Emergency Use


According to the global real-time statistics system of new coronary pneumonia data released by Johns Hopkins University in the United States, as of 6 pm Eastern Time on August 19, a total of 5,516,639 confirmed cases of new coronary pneumonia and 172,667 deaths have been reported across the United States. In the past 24 hours, the United States has newly confirmed 42009 cases and 1151 new deaths.

The current situation of the US epidemic is still severe. Behind the increasing number of confirmed cases is the huge demand for new crown testing reagents in the US. On August 17, 2020, the new coronavirus antibody detection kit (magnetic particle chemiluminescence method) developed by Sophonix was authorized by the US FDA for emergency use. It opened the door to the US market and made China a global anti-epidemic. contribution.

The new coronavirus antibody detection reagent developed by Sophonix can meet the requirements of simultaneous detection of IgG and IgM antibodies, and complete the whole reaction within 30 minutes to confirm whether the subject is infected with the virus. The data shows that the clinical sensitivity of IgM antibody detection developed by the company is 99.1%, the clinical specificity is as high as 100%, the clinical sensitivity of IgG antibody detection is 95.5%, and the clinical specificity is 97.2%.

Previously, this product has obtained CE certification and quickly sold to Italy, the Netherlands and other countries. The FDA approval this time marks Sophonix’s further access to the global market.

Li Feng, General Manager of Sophonix, said: “The company has reached a comprehensive cooperation with Accelerate Diagnostics, a Nasdaq listed company. With the help of the company’s large sales force in the United States and Europe, it can help the company’s new coronavirus antibody detection reagents quickly enter the European and American markets. The global fight against the epidemic.”

In addition, Sophonix has formed a close cooperative relationship with Biocheck in the United States, and the new coronavirus antibody detection kit will be produced in the United States. In this way, transportation time can be greatly saved, and at the same time, with the help of the American technical team to respond quickly and better serve local customers, it will also help the company’s subsequent 510(k) declaration in the United States.

Li Feng judged: “New coronavirus testing will become a normalized testing item in the future. On the one hand, antibody testing will become a routine testing item in fever clinics. On the other hand, after the vaccine is marketed, antibody testing needs to be used to determine whether the vaccine is effective.” Therefore, The market demand for antibody detection kits will become a continuous demand.

Advancement is the core competitiveness
Multiple measures to ensure accuracy and detection speed

After the human body is infected with the new coronavirus, it will produce IgM or IgG antibodies. By detecting the IgM and IgG antibodies in the serum, it can be confirmed whether the testee is infected with the virus. Combined with the molecular test, the new coronavirus infection can be detected more accurately, and the epidemic prevention Control is of great significance.

In general, the significance of the new coronavirus antibody test is mainly reflected in the rapid investigation of suspected patients, understanding and evaluating the spread and penetration of the new coronavirus, testing the effectiveness of epidemic prevention and control measures, and providing guidance for “unblocking” and resuming production. Role etc.

After the superiority of antibody detection products has been verified, major in vitro diagnostic manufacturers including Sophonix have begun relevant research and development, and many products have been certified by China, the European Union and the United States.

In fact, Sophonix is ​​not the first manufacturer of new coronavirus antibody detection reagents approved by the FDA. Even judging from the time point, Sophonix’s approval time is not fast. Although it seems “a step slower”, the company’s new coronavirus antibody detection reagents have won unanimous praise from doctors and experts. This is due to the excellent product performance of the kit.

Sophonix’s new coronavirus antibody detection reagent uses magnetic particle chemiluminescence method. The magnetic particle chemiluminescence method adds magnetic nanoparticles to the chemiluminescence detection. It is the most mainstream diagnostic method for immunodiagnosis, which can achieve higher sensitivity and specificity, and faster detection speed.

It is worth noting that both N protein and S protein are related to the new coronavirus infection. Detection of N protein antibody and S protein antibody can judge the infection. However, the N protein of the new coronavirus has more than 90% homology with other coronaviruses, and the S protein of the new coronavirus (which can be divided into two parts S1 and S2 according to the spatial structure) has 88% homology with the S protein of other coronaviruses. The homology of the new coronavirus S1 protein to other coronavirus S1 proteins is less than 75%. Therefore, the specificity of S1 protein is higher than that of N protein and S protein.

Sophonix uses the S1 protein as the capture protein for antibody detection, which effectively improves the specificity of new coronavirus antibody detection.

In addition, the company uses a single-part kit, which can quickly issue test results on the spot, which is very suitable for primary medical institutions, communities and township health centers to screen suspected patients, and can effectively control the spread of the new coronavirus.

The R&D story behind
Use rigorous research and development thinking to ensure product performance

With the gradual deepening of people’s understanding and research on the new coronavirus, nucleic acid testing is no longer the only choice for determining infection, and new coronavirus antibody testing has gradually become an important means of assisting diagnosis for suspected patients with new coronary pneumonia.

As an in-vitro diagnostic company that is deeply involved in chemiluminescence POCT, Sophonix always pays attention to market demand trends. “We firmly believe that by doing what we are good at, we can better ensure the high sensitivity and high specificity of our products, so that we can deliver high-quality and valuable products to the market.” The immunodiagnostic product line is one of the company’s main businesses, antibody detection After receiving attention, the company immediately began to develop new coronavirus antibody detection kits.

According to Li Feng’s recollection, after the outbreak, the company quickly assembled relevant personnel to return to their posts and set up a special scientific research team for “Fighting New Coronary Pneumonia Virus” to develop new coronavirus antibody detection kits overnight from the second day of the new year. At that time, it was a key node in the prevention and control of the epidemic. Most of the raw material manufacturers stopped work, and roads in various places were closed. The company’s research and development work was facing great difficulties.

“Under the difficulties, Sophonix made full use of various resources and multiple channels to find suitable raw material manufacturers, and finally found a good adaptable raw material.” After solving the problem of raw material supply, logistics and transportation are also a major problem. “We went to the factory in person. , The raw materials were shipped back smoothly.”

In early March, the development of new coronavirus antibody detection reagents was successfully completed. Afterwards, Li Feng and the company’s R&D team went to the frontline of Wuhan’s anti-epidemic to understand the real needs of the frontline, carry out clinical trials and related scientific research cooperation, and continuously improve product performance after rigorous verification and a large amount of data comparison.

In April, Sophonix began to declare EUA in the United States. On August 17, the new coronavirus antibody detection reagent developed by the company was authorized by the US FDA for emergency use. “The FDA represents the most stringent review system. The emergency use authorization of the FDA is sufficient to prove the advanced nature and reliability of the company’s products.”

Multi-method, multi-item joint detection
Cover the entire process of initial screening, diagnosis, and prognosis of the new coronavirus

In addition to the FDA-approved immunological method for the detection of new coronavirus antibody kits, Sophonix has also carried out scientific research cooperation with the Institute of Microbiology of the Chinese Academy of Sciences to develop the GM-Fast series of automatic isothermal nucleic acid rapid analyzers based on LAMP technology and its supporting nucleic acid detection reagents box. In response to the cytokine storm that is likely to occur during the treatment of new coronaviruses, the company has developed IL-2, IL-6, IL-8, IL-10, IL-18, GM-CSF, MCP-1, IFN-γ, TNF- Alpha and other cytokine storm immunoassay kits cover the whole process of initial screening, diagnosis and prognosis of the new coronavirus. At the same time, the new coronavirus antigen detection kit is actively registered, which will further improve the company’s new coronavirus detection product line.

About Sophonix

Sophonix is ​​committed to accurate and rapid in vitro diagnostic products, and is the domestic leader in chemiluminescence POCT. The company focuses on POCT scenarios and combines advanced detection technology platforms to provide multi-directional, more repeatable and accurate POCT solutions.

The company has established three product lines for pathological diagnosis, immunodiagnosis and molecular diagnosis. The pathological diagnosis product line includes Ultra 60 and Ultra 30 automatic immunohistochemical staining machines and its supporting secondary antibody reagents; the immunodiagnostic product line includes myocardial, inflammation, sex hormones, thyroid function, anemia, tumor, bone metabolism, brain injury, etc. Among them, the traumatic brain injury marker is Sophonix’s exclusive product, which can complete the rapid detection of brain injury within 30 minutes.

During the epidemic, Sophonix gave full play to the social responsibility of in vitro diagnostic companies and donated more than 100,000 immunoassay reagents to medical institutions at all levels across the country.

Sophonix adheres to customer-centered, product quality as the foundation of the company, and escorts human life and health through continuous technological innovation.


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