Medcaptain's SARS-CoV-2 Antibody Test Receives FDA Emergency Use Authorization, Expanding Global Market Access

According to the real-time global COVID-19 statistics system released by Johns Hopkins University in the United States, as of 6:00 p.m. Eastern Time on August 19, the United States had reported a total of 5,516,639 confirmed cases and 172,667 deaths. In the past 24 hours, the U.S. recorded 42,009 new confirmed cases and 1,151 new deaths.

Currently, the epidemic situation in the United States remains severe, with the daily rise in confirmed cases driven by a massive demand for COVID-19 testing reagents. On August 17, 2020, the Novel Coronavirus Antibody Test Kit (Magnetic Particle Chemiluminescence Immunoassay), developed by Sophonix Co., Ltd., received Emergency Use Authorization (EUA) from the U.S. FDA, opening the door to the U.S. market and contributing China’s efforts to the global fight against the pandemic.

The novel coronavirus antibody test kit developed by Sophonix Co., Ltd.It enables simultaneous detection of IgG and IgM antibodies, completing the entire reaction process within 30 minutes.Confirm whether the subject is infected with the virus. Data shows that,The IgM antibody test developed by the company demonstrated a clinical sensitivity of 99.1% and a clinical specificity of up to 100%, while the IgG antibody test showed a clinical sensitivity of 95.5% and a clinical specificity of 97.2%.

Previously, this product had already obtained CE certification and was rapidly marketed to countries such as Italy and the Netherlands. This recent FDA approval marks Sophonix Co., Ltd.’s further penetration into the global market.

Li Feng, General Manager of Sophonix Co., Ltd., stated: “The company has entered into a comprehensive partnership with Accelerate Diagnostics, a Nasdaq-listed company. Leveraging its extensive sales force in the United States and Europe, this collaboration will facilitate the rapid entry of our novel coronavirus antibody test kits into the European and American markets, thereby contributing to global efforts against the pandemic.”

In addition, Sophonix Co., Ltd. has established a close partnership with Biocheck Inc. in the United States, under which its COVID-19 antibody test kits will be manufactured domestically in the U.S. This approach significantly reduces shipping lead times and leverages a local technical team for rapid response, thereby better serving customers in the region. It also facilitates the company’s upcoming 510(k) submission to the U.S. FDA.

Li Feng assessed: “COVID-19 testing will become a routine screening item in the future.“On the one hand, antibody testing will become a routine test in fever clinics; on the other hand, after vaccines are launched, antibody testing is needed to determine their efficacy.” Therefore, market demand for antibody test kits will become sustained.

Advancedness is the core competitiveness.

Multiple Measures to Ensure Accuracy and Testing Speed

Following human infection with the novel coronavirus (SARS-CoV-2), IgM and IgG antibodies are produced. Detection of serum IgM and IgG antibodies can determine whether an individual has been infected with the virus. When combined with molecular testing, this approach enables more accurate identification of SARS-CoV-2-infected individuals, which holds significant importance for epidemic prevention and control.

Overall, the significance of SARS-CoV-2 antibody testing is mainly reflected in the rapid screening of suspected cases, understanding and assessing the spread and penetration of the virus, evaluating the effectiveness of epidemic prevention and control measures, and providing guidance for lifting lockdowns and resuming work and production.

Following validation of the superiority of antibody testing products, major in vitro diagnostic (IVD) manufacturers, including Sophonix Co., Ltd., have embarked on related research and development efforts. To date, numerous such products have obtained certifications in China, the European Union, and the United States.

In fact, Sophonix Co., Ltd. was not the first manufacturer to receive FDA approval for its COVID-19 antibody test kits. Indeed, in terms of timing, Sophonix’s approval was not particularly rapid. Although it appeared to be “a step behind,” the company’s COVID-19 antibody test kits have earned widespread acclaim from physicians and experts alike, thanks to their superior product performance.

Sophonix's SARS-CoV-2 antibody test kit adoptsMagnetic Particle Chemiluminescence Assay. Magnetic microparticle chemiluminescence immunoassay incorporates magnetic nanoparticles into conventional chemiluminescence detection, representing the most mainstream approach in immunodiagnostics, enabling higher sensitivity and specificity as well as faster assay speed.

It is worth noting that both the N protein and the S protein are proteins associated with SARS-CoV-2 infection, and detection of antibodies against either the N protein or the S protein can be used to determine infection status. However, the SARS-CoV-2 N protein shares over 90% homology with those of other coronaviruses, while the SARS-CoV-2 S protein (which can be divided into two subunits, S1 and S2, based on its spatial structure) shares 88% homology with the S proteins of other coronaviruses.The homology between the SARS-CoV-2 S1 protein and other coronavirus S1 proteins is less than 75%. Therefore, the S1 protein exhibits higher specificity than the N protein and the S protein.

Sophonix Co., Ltd. uses the S1 protein as the capture antigen for antibody detection, effectively enhancing the specificity of SARS-CoV-2 antibody tests.

In addition, the company adoptsSingle-Use Test Kit, enabling rapid on-site generation of test results, making it highly suitable for screening suspected patients at primary healthcare institutions, communities, and township health centers, thereby effectively controlling the spread of SARS-CoV-2.

The R&D Story Behind It

Ensuring Product Performance with Rigorous R&D Thinking

As understanding and research of the novel coronavirus deepen, nucleic acid testing is no longer the sole option for determining infection; antibody testing for SARS-CoV-2 has gradually become an important adjunctive diagnostic tool for suspected COVID-19 cases.

As an in vitro diagnostics company deeply engaged in chemiluminescence-based POCT, Sophonix Co., Ltd. has always been attentive to market demand trends. “We firmly believe thatFocusing on areas of expertise better ensures high sensitivity and high specificity, thereby delivering high-quality, valuable products to the market."Immunodiagnostic product lines are one of the company's core businesses. Following the heightened attention on antibody testing, the company immediately initiated the research and development of novel coronavirus antibody test kits."

According to Li Feng, after the outbreak of the epidemic, the company quickly recalled relevant personnel to their posts and established a special scientific research team for “Fighting the Novel Coronavirus Pneumonia.” Starting from the second day of the Lunar New Year, the team worked overnight to develop antibody detection kits for the novel coronavirus. At that time, it was a critical period for epidemic prevention and control; most raw material manufacturers had suspended production, and roads across various regions were closed, posing significant challenges to the company’s R&D efforts.

“Amidst layer upon layer of difficulties, Sophonix Co., Ltd. leveraged various resources and multiple channels to identify suitable raw material suppliers, ultimately securing materials with excellent compatibility.” After resolving the raw material supply issue, logistics emerged as another major challenge. “We personally visited the factory to ensure the successful transportation of the raw materials back.”

In early March, the development of reagents for novel coronavirus antibody testing was successfully completed. Subsequently, Li Feng and the company’s R&D team traveled to the front lines of the epidemic response in Wuhan to gain an in-depth understanding of real-world clinical needs, conduct clinical trials, and engage in related scientific research collaborations. Through rigorous validation and extensive data comparison, they continuously optimized the product’s performance.

In April, Sophonix Co., Ltd. began submitting its Emergency Use Authorization (EUA) application in the United States. On August 17, the company’s novel coronavirus antibody detection kit received Emergency Use Authorization from the U.S. FDA.“The FDA represents the most rigorous review system, and obtaining the FDA’s Emergency Use Authorization is sufficient to demonstrate the advanced nature and reliability of the company’s products.”

Multi-Method, Multi-Analyte Combined Testing

Covering the entire process of initial screening, diagnosis, and prognosis for COVID-19

In addition to its FDA-approved immunoassay kits for detecting SARS-CoV-2 antibodies, Sophonix Co., Ltd. has collaborated with the Institute of Microbiology, Chinese Academy of Sciences, to develop and complete the GM-Fast series of fully automated isothermal nucleic acid rapid analyzers based on LAMP technology, along with their corresponding nucleic acid detection kits. To address cytokine storms, which frequently occur during the treatment of COVID-19, the company has developed a range of immunoassay kits for multiple cytokines associated with cytokine storms, including IL-2, IL-6, IL-8, IL-10, IL-18, GM-CSF, MCP-1, IFN-γ, and TNF-α.Covers the entire process of initial screening, diagnosis, and prognosis for COVID-19. Meanwhile, the novel coronavirus antigen test kits are actively undergoing registration, which will further enhance the company’s product portfolio for novel coronavirus testing.

Sophonix is dedicated to precise and rapid in vitro diagnostic products, standing as a leading provider of chemiluminescence-based POCT solutions in China. Centered on POCT scenarios and leveraging advanced detection technology platforms, the company delivers comprehensive, highly reproducible, and accurate precision POCT solutions.

The company has currently established three product lines: pathological diagnosis, immunodiagnostics, and molecular diagnostics. The pathological diagnosis product line includes the Ultra 60 and Ultra 30 fully automated immunohistochemistry staining systems and their corresponding secondary antibody reagents; the immunodiagnostics product line covers series for cardiac markers, inflammation, sex hormones, thyroid function, anemia, tumors, bone metabolism, and brain injury.Among these, the traumatic brain injury biomarker is an exclusive product of Sophonix Co., Ltd., enabling rapid detection of brain injury within 30 minutes.

During the pandemic, Sophonix Co., Ltd. fully demonstrated its social responsibility as an in vitro diagnostics enterprise by donating more than 100,000 test kits of relevant immunoassay reagents to medical institutions at all levels across China.

Sophonix Co., Ltd. remains committed to a customer-centric approach, upholding product quality as the foundation of its enterprise. Through continuous technological innovation, we safeguard human life and health.