Export whitelist of MOFCOM of PRC & EU CE certification for Novel Coronavirus (2019-nCoV) Neutralizing Antibody Detection Kit


  Up to now, more than ten novel coronavirus vaccines have been approved for marketing or emergency use in many countries and regions. According to the real-time tracking data of global novel coronavirus vaccines updated by Tencent News on August 16, the global cumulative vaccination volume has reached 4.7 billion doses. As the novel coronavirus vaccines is widely vaccinated around the world, people have questions about whether the vaccine has produced antibodies in the body and whether novel coronavirus vaccine boosters are needed. The Novel Coronavirus (2019-nCoV) Neutralizing Antibody Detection Kit can objectively evaluate the effect of vaccination and provide data reference for the above questions after vaccination.


Advantages of neutralizing antibody detection

Nucleic acid detection and IgM/IgG antibody detection have been widely known. Nucleic acid detection can directly detect the presence of novel coronavirus in the body, and is mainly used for immediate diagnosis of novel coronavirus. The IgM/IgG antibody detection is to detect the presence of total antibodies in the body to determine whether it has been infected with the novel coronavirus. The neutralizing antibody detection is fundamentally different from them. Compared with the IgM/IgG antibody detection, the neutralizing antibody detection can accurately detect the presence and level of the neutralizing antibody, and then determine whether the human body has established immunity to against the novel coronavirus.


In November 2020, Beijing Biosis Healing Biological Technology Co., Ltd and Zhongguancun Zhongyan Health Science and Technology Research Institute (referred to as Zhongyan Institude) jointly developed Novel Coronavirus (2019-nCoV) Neutralizing Antibody Detection Kit--- Biosis Healing Novel Coronavirus (2019-nCoV) Neutralizing Antibody Detection Kit (Colloidal Gold Immune-Chromatography) is used to evaluate the level of neutralizing antibodies in humans after being vaccinated with 2019-nCoV vaccine and recovering from infection, which has become the first echelon company to enter this field in the world.

Biosis Healing the Novel Coronavirus (2019-nCoV) Neutralizing Antibody Detection Kit

Biosis Healing Novel Coronavirus (2019-nCoV) Neutralizing Antibody Detection Kit (Colloidal Gold Immune-Chromatography), this product refers to the relevant review points of the Novel Coronavirus diagnostic reagents issued by the National Medical Products Administration, based on the novel coronavirus pseudovirus detection system (this system is the main method for the quality evaluation of domestic vaccines). Zhongyan Institude compared the method with live coronavirus, the correlation is greater than 90%, and it has also been compared with the standard product of the China Inspection Institute and the value of WHO international standard product. Through this system, the quantification of serum neutralizing antibodies can be achieved.

In the case detection and analysis conducted by Biosis Healing and the Zhongyan Institude, the neutralization detection with a positive judgment value of NT50 of 30 was performed on 350 cases including pre-immunization, post-immunization, and contrast of serum tests of recovered patients, and compare with the neutralization titer greater than 30, the relative sensitivity is 96.7%, the relative specificity is 97.9%, and the total coincidence rate is 97.4%.

The detection kit is simple and convenient to operate, without equipment, individual can complete the detection, the detection result can be obtained within 15 minutes, and it can be transported and stored at room temperature.


Export whitelist of the Ministry of Commerce of the Peoples Republic of China+ EU CE certification Biosis Healing Novel Coronavirus (2019-nCoV) Neutralizing Antibody Detection Kit was officially approved for export

 In June 2021, Biosis Healing Novel Coronavirus (2019-nCoV) Neutralizing Antibody Detection Kit (Colloidal Gold Immune-Chromatography) was officially approved by the EU CE certificate. In August 2021, the product officially entered the Chinese Ministry of Commerce's export whitelist and obtained export qualifications.




Since the outbreak of the COVID-2019 pandemic in 2020, Biosis Healing has used years of experience in the production management and quality control of the Class II and Class III medical device registration certificate, to urgently switch to the production of the COVID-19 pandemic prevention materials to help the world fighting against the COVID-2019 pandemic and show the world the strength and sense of responsibility of Chinese medical companies. In the post-the COVID-2019 pandemic era, as the global vaccination rate continues to rise, the demand for neutralizing antibody detection for testing the effects of vaccines continues to increase. And we also hope that in the post-the COVID-2019 pandemic era, Biosis Healing will continue to contribute to the global fighting against the COVID-2019 pandemic.

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Angela Qiu: 13581890639

Chris: 15911020280

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