List of COVID-19 Rapid Test Kits Manufacturers in China (with CE and CFDA)
- POCT: Point Of Care Testing
- CFDA: China Food and Drug Administration
- NMPA: National Medical Products Administration(Formerly known as CFDA)
We think the first choice is to choose a manufacture that has U.S. FDA, CE and CFDA certification. The second choice is a manufacture that has CD and CFDA certification. The third choice is a manufacture only has CE certification. So, we collected information on suppliers with CE & CFDA certification and their COVID-19 Rapid Test Kits. Hope that will help you to select your preferred IVD manufacturer.
Let’s get started.
Wondfo Biotech is specialized in R&D, manufacture and sales of rapid diagnostic reagents and related equipment, a globally recognized fast growing POCT leader in China. Founded in 1992, went public in June, 2015. They have got CE certificates, FDA certificates, FSC certificates, ISO 9001:2008 and ISO 13485:2012 quality system certification.
On Feb 22nd 2020, Wondfo One Step COVID-19 Antibody Test (Immunochromatography Assay) developed by Wondfo has been approved by NMPA.
On 5th March , Wondfo has completed the application of CE mark for three SARS-CoV-2 antibody rapid tests, making Wondfo the first Chinese medical device company in POCT industry that receives the most CE marks for novel coronavirus antibody test.
Wondfo SARS-CoV-2 Antibody Test (Lateral Flow Method) is an immunochromatographic assay for rapid, qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) IgG/IgM antibody in human whole blood, serum or plasma sample. The test is to be used as an aid in the diagnosis of coronavirus infection disease (COVID-19), which is caused by SARS-CoV-2.This rapid test can aid in the diagnosis of coronavirus infection and significantly shorten the detection time, yielding the results in 15 minutes.
The FinecareTM SARS-CoV-2 IgM Test and the FinecareTM SARS-CoV-2 antibody Test are fluorescence immunoassay used along with FinecareTM FIA Meters (Model Code: FS-113, FS-114, FS-205) for qualitative detection of IgG and IgM antibodies of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in human serum, plasma and whole blood sample. Clinically, the test is to be used as an aid in the diagnosis of coronavirus infection disease (COVID-19), which is caused by SARS-CoV-2.
The three SARS-CoV-2 antibody rapid tests entitled to CE certificates are:
Wondfo SARS-CoV-2 Antibody Test (Lateral Flow Method)
FinecareTM SARS-CoV-2 IgM Test
FinecareTM SARS-CoV-2 antibody Test
Livzon Diagnostics was established in 1989. It is the first high-tech subsidiary of the listed company, Livzon Pharmaceutical Group (A-share and H-share listed company), who specializing in in-vitro diagnostics in research, developing, manufacturing and marketing of diagnosis products and automation equipment. Livzon Diagnostics is one of the earliest in vitro diagnostic products manufacturing enterprises in China, a national high-tech enterprise. Their products cover infectious diseases, respiratory tract infections, tumor marker detection, drug concentration monitoring, autoimmunity, allergen detection and blood safety and many other fields.
The Diagnostic Kit for IgM / IgG Antibody to Coronavirus (SARS-CoV-2) (Lateral Flow) is compatible with serum/ plasma/ venous whole blood and only need 15 minutes to get the result.
Vazyme Biotech is devoted to the development and production of enzymes and antibodies. Their products cover clinical diagnosis, molecular diagnostics, high-throughput sequencing and life science research and other related fields. At present, Vazyme Biotech has successfully transformated more than 30 kinds of enzymes and improved the quality of the enzyme involved catalytic activity, half life, stability, heat resistance, anti disturbance to reach the international first-class level.
The 2019-nCoV IgG/IgM Detection Kit(Colloidal Gold-Based) developed by Vazyme Biotech has been approved by NMPA,CE and Singapore HAS(Health Sciences Authority). This product is intended to detect the IgG / IgM of 2019-Novel Coronavirus (2019-nCoV) from human serum, plasma. Rapid detection within 10 mins and no testing equipments required.
Bioneovan was established in 2005, focusing on the detection of children's respiratory, hepatitis and digestive diseases.
This kit is established with a colloidal gold immunochromatography technique for the rapid detection of IgM and IgG antibodies against 2019-nCoV in serum, plasma or whole blood samples. Rapid and easy to use, no instrument required, yielding the results in 15 minutes.
Innovita was established in 2006 in Beijing, is a Chinese high-tech enterprise specialized in R&D, manufacturing, marketing and after-sales service of In-vitro diagnostic tests. With certification of CE, ISO 13485, Innovita has an extensive product line include Fertility, Infectious Diseases, Sexually Transmitted Diseases, TORCH, Respiratory Diseases, Drug Abuse, Tumor Marker and Cardiac marker tests.
On Feb 22nd 2020, 2019-nCoV Ab Test-Colloidal-Gold developed by Innovita has been approved by NMPA.
This kit is intended for qualitative detection of IgM and IgG antibodies against 2019 Novel Coronavirus(2019-nCoV) in human serum/plasma/venous whole blood specimen and for the auxiliary diagnosis of 2019-nCoV infection. Read results in 15 minutes and no testing equipments required.
Hecin Scientific was established in April 2015, focusing on research and development of IVD products on respiratory viruses. The incubator is based on the National Key Laboratory of Respiratory Diseases led by Zhong Nanshan, who is the member of Chinese Academy of Engineering and leading scientist in the field of respiratory diseases. Hecin Scientific owns 5,000 m2 GMP factory and state of the art facility for the innovation by highly motivated people to create and produce new IVD products.
On March 11, 2020, Guangdong Hecin Scientific, Inc., the State Key Laboratory of Respiratory Diseases, the Guangdong Laboratory of Regenerative Medicine and Health, the Guangzhou Institute of Biomedicine and Health, Chinese Academy of Sciences and Guangzhou Enbao Biomedical Technology Co., Ltd. Announced that their collaborative product of COVID-19 IgM antibody rapid test kit (colloidal gold method) had been approved by NMPA.
On March 11, they get the CE certificate CE certification.
COVID-19 IgM antibody rapid test kit (Colloidal Gold Method) is used for the qualitative detection of 2019-nCoV IgM antibodies in human serum and plasma samples in vitro. Reaction at room temperature, results in 15 minutes, can be used as a supplementary method to help diagnosis of COVID-19.
Future articles in this series will guide you through finding trusted Chinese IVD suppliers. Look out for them here.
I hope you’ve found this guide useful. If you have any questions or tips on locating IVD suppliers in China, be sure to comment below.
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