List of COVID-19 Fluorescent PCR Kit 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 Fluorescent PCR reagents. Hope that will help you to select your preferred IVD manufacturer.
Let’s get started.
Founded in 1999, BGI is one of the world's leading life science and genomics organizations. In April 2003, BGI successfully sequenced the SARS virus in less than 20 hours, and developed an enzyme immunoassay test kit in 96 hours.
In 2011, BGI successfully and rapidly developed a free diagnostic kit for the Enterohaemorrhagic Escherichia Coli (EHEC) epidemic that broke out in Germany.
On Jan 26nd 2020, the Real-Time Fluorescent RT-PCR kit for detecting 2019-nCoV which can issue results in a few hours developed by BGI approved by NMPA.
On March 27nd 2020, BGI announced that its new coronavirus nucleic acid detection kit has obtained the US FDA emergency use authorization (EUA).
Maccura was founded in 1994 and has been focusing on the research, manufacture, marketing, and services of IVD products. Their products have covered platforms of biochemistry, immunoassay, POCT, hematology, molecular diagnosis and pathology, and could meet more than 90% requirements of medical labs with the product integration.
Maccura has become the first Chinese enterprise member of IFCC in 2010, and been certified by CNAS in 2013.
In 2015, the reference system department of Maccura has been the first enterprise laboratory in China to enter the JCTLM list and become the cooperation member of IRMM to undertake the assignment for international reference materials.
Maccura’s SARS-CoV-2 Fluorescent PCR Kit (for the COVID-19 Coronavirus) has been approved by CE, NMPA. And FDA-EUA. And it was used in many hospitals from EU & Asia & Others and got high reputation. This kit is used to detect nucleic acid with Oropharyngeal swabs, sputum. It only takes two hours.
They also have another method of COVID-19 IVD Test Solution:
SARS-CoV-2 IgM/IgG(CLIA, chemiluminescence immunoassay): with CE and CFDA.
Sansure Biotech Inc. was founded in 2008 as a dedicated company developing and manufacturing a complete product line for molecular laboratories, ranging from upstream nucleic acid extraction kits and full automation to downstream real time PCR diagnostic & research kits and fluorescence systems.
The Novel Coronavirus(2019-nCoV) Nucleic Acid Diagnostic Kit(PCR-Fluorescence Probing) developed by Sansure Biotech has been approved by CFDA, CE and FDA-EUA.
- One-tube technology, extraction within 30minutes
- Up to 96 samples at one time
- Simple operation process, no need long term staff training
- Room temperature nucleic acid lysis, No heating
- Direct sample types include: Nasal, Throat, and Nasopharyngeal swabs
- Enhance screening efficiency
BioGerm (hereinafter referred to as“BioGerm”) was established in March 2017. It is a high-tech company dedicated to the development and application of molecular diagnostic reagents for infectious pathogens, especially multiple fluorescent PCR diagnostic reagents.
The PCR kit is called Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit(PCR-Fluorescence Probing),it is designed for the qualitative detection of 2019-nCoV, and the results indicate the presence of 2019-nCoV nucleic acid and can be used to support the diagnosis of 2019-nCoV infection. The sensitivity is 1000 copies/mL, it will take about 1.5h to get the result. It has been approved by CFDA, CE and FDA-EUA.
CapitalBio Technology was registered in August 2012. They has successfully developed dozens of products and services with independent intellectual property rights, including biochips and related reagent consumables, instruments and equipment, software databases, life science services, clinical testing services, and health management, among which more than ten are international firsts. Obtained more than 130 internal certifications such as CFDA, CE, GS, CB, etc.
On Mar 26, Respiratory Virus Nucleic Acid Detection Kit (Isothermal Amplification Chip Method) from CapitalBio Technology aquired CE certificate. The kit is jointly developed by CapitalBio Corporation, Tsinghua university and West China Hospital，Sichuan University.
It could detect six kinds of respiratory virus including 2019-nCoV and take only 1.5 hours for entire process.
- Novel Coronavirus (2019-nCoV)
- Influenza A Virus
- New Influenza A (H1N1) Virus(2009)
- Influenza A (H3N2) Virus
- Influenza B Virus
- Respiratory Syncytial Virus
Liferiver is a leading PCR-based molecular diagnostics solution provider, developing, manufacturing & marketing real time PCR diagnostic kits as well as instruments. They offer over 400 testing kits covering most infectious diseases, genetic diseases, tumors, organ transplants & others. Their kits are compatible with most real time PCR systems of various brands including ABI, Bio-Rad and Roche.
The Novel Coronavirus (SARS-CoV-2) test is the 1st IVD approved by CFDA(China's FDA), for detection of 2019-nCoV RNA. It has been validated with around 200 natural clinical specimens, with close to 100 positive ones. This test is CE marked and approved by TGA in Australia. This test has been sold and widely used in China as well as more than 40 countries such as Italy, Spain, Portugal, Czech, Germany, Oman, UAE, Thailand. Malaysia, Colombia, etc.
On May 22nd 2020,World Health Organization (WHO) approved Liferiver’s Novel Coronavirus (SARS-CoV-2) Real Time Multiplex RT-PCR Kit under WHO Emergency Use Listing. There are less than 10 tests with such approval so far.
This is the 3rd time that Liferiver assay is approved by WHO, following Ebola kit in 2015 and Zika kit in 2018 In that, Liferiver is the only company around the world whose corresponding detection kits have been approved by WHO during last three Public Health Emergencies of International Concern (PHEIC) declared by the Director-General of WHO.
EasyDiagnosis Biomedicine was established in 2008. It is a company specializing in providing in vitro diagnostic reagents and supporting equipment(POCT, molecular diagnostics, chemiluminescence,blood gas analysis, etc.).
The immune quantitative detection platform developed by EasyDiagnosis Biomedicine can be one-step operation, intelligent identification, quickly obtain test results within 15 minutes, and is compatible with the detection of nearly 30 immune markers. It has covered 4,000 medical institutions in 30 provinces in China, and achieved sales coverage in Asia, the European Union, South America and other regions.
The COVID-19 SARS-CoV-2 Nucleic Acid Test Kit developed by EasyDiagnosis Biomedicine is a real-time RT-PCR test kit. It is intended for the qualitative detection of nucleic acid from the SARS-CoV-2, in upper and lower respiratory tract specimens (such as oropharyngeal swabs, nasopharyngeal swabs and sputum.
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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