No matter you are a distributor or clinic owner, if you want to import rapid test kit from China, you may have encountered the below questions at the start:
Where to buy a rapid test kit in China?
What are the best rapid test kit manufacturers in China?
Don't worry. You have come to the right place.
We will reveal all that you need to know in this ultimate guide.
How?
We have waded through the overwhelming number of China rapid diagnostic test suppliers to sort out the best from the rest.
So you can have complete confidence when it comes to selecting your preferred rapid test kit factories in China.
Let’s get started, enjoy it!
About the Data Source
For your reference, here are the data sources this guide is based on:
- National Medical Products Administration
- China Customs
- China Industry and Commerce Bureau
- Official website of diagnostic test companies
- Annual Report
- Interviews with experts in the field of medical device
- Interviews with salesmen of medical equipment companies
Main Medical Device Manufacturers Regions
Where to buy Rapid Test Kits in China? You may need to know the medical device industry regions first to get a general idea.
Below four provinces are home to most of China’s commercial medical device manufacturers:
- Guangdong
- Jiangsu
- Shandong
- Zhejiang
The Distribution of Medical Device Manufacturers in China
Who is the Best Rapid Test Kit Manufacturer in China?
Here are the top 10 rapid test kit manufacturers in China:
- Wondfo | A Leader in China's POCT Industry
- Getein Biotech | Pursue Excellence and Deliver Health
- EasyDiagnosis
- Sansure Biotech | Innovating diagnostics for all
- Orient Gene Biotech
- Alltest Biotech
- Biotime
- Hotgen Biotech
- Ustar Biotechnologies
- Hipro Biotechnology
Let’s check more details one by one.
Wondfo | A Leader in China's POCT Industry
Brief Introduction
Wondfo is one of the leading POCT(Point-of-care testing) industry suppliers and rapid test kit manufacturers in China. It has been operating since 1992, has been focusing on the R&D, production, sales and service of POCT products. Wondfo has the distinction of being the first POCT manufacturer listed in China.
Wondfo has a wide range of products for the rapid test of cardiovascular diseases, inflammation, tumor, infectious diseases, drug abuse, pregnancy and so on. Their main technologies are colloidal gold and Immunofluorescence. They have got MDSAP, FDA(US), HC(Canada), TGA(Australia), ANVISA(Brazil) certification, and their products are sold in more than 140 countries around the world.
Registration Information
Factory：Guangzhou City, Guangdong Province
Key Products
Wondfo has a huge product range, including detecting infectious disease, chronic disease, drug of abuse, sex hormones, etc. Infectious disease testing products account for more than 50% of revenue , including HIV, TP, HCV, HBsAg, Flu A&B, COVID-19 test kits. Chronic disease is about 20% of revenue, such as cTnI/CK-MB/Myo, BNP, HbA1c, Cys C rapid quantitative test.
Wondfo One Step HIV 1-2 Oral Mucosal Transudate Test
Wondfo The Finecare One Step cTn I-CK-MB-Myo Rapid Quantitative Test
Main Markets(International Market)
Top 10 Clients(International Market)
Review
Wondfo is one of the earliest rapid test kit suppliers in China's POCT industry, has the most technical platform and the richest product line. Wondfo has more than 20 years experience in international sales. Due to the substantial increase in sales of COVID-19 test kit, their international market sales reached ￥1.26 billion, accounting for 44.93%, it’s only ￥428 million and 20.73% in 2019.
Getein Biotech | Pursue Excellence and Deliver Health
Brief Introduction
Getein Biotech, which is based in Nanjing, has been in business since 2002. It has 7 product lines consisting of cardiovascular, inflammatory, diabetes, fertility, renal, liver and specialty assays among many others.
Colloidal gold, fluorescence immunochromatography, biochemistry, chemiluminescence and diagnostic materials are their main technology platforms.
Getein Biotech has obtained ISO 13485:2016, CE Marking and MDSAP, and is selling its POCT products in more than 110 countries around the world.
Registration Information
Factory：Nanjing City, Jiangsu Province
Key Products
Its main product line are the cardiovascular and inflammatory detecting series, which is about 90% of reagent revenue.
Getein1600 Immunofluorescence Quantitative Analyzer is the most popular diagnostic analyzer.
Getein CK-MB-cTnI-Myo Fast Test Kit(Immunofluorescence Assay)
Getein 1600 Immunofluorescence Quantitative Analyzer
Main Markets(International Market)
Top 10 Clients(International Market)
Review
Getein Biotech is well known in China, and they have various antigens and antibodies for diagnostic reagents. They began to explore the international market in recent years, only having CE marking so far. Their international market sales is only ￥33.1 million in 2019, but it grew to ￥131 million in 2020. Getein Biotech will be a good choice for your business.
EasyDiagnosis
Brief Introduction
EasyDiagnosis, based in Wuhan Province, has a 13-year history of supplying POCT products in China. They focus on R&D, production and sales of In-Vitro Diagnostics reagents, including POCT, chemiluminescence, blood gas analysis, molecular diagnosis etc.
More than 100 products have NMPA certification, 6 products passed CE certification. And their COVID-19 (SARS-CoV-2) Antigen Test Kit has CE, TGA and ANVISA certification.
Registration Information
Factory：Wuhan City, HubeiProvince
Key Products
EasyDiagnosis is the first company to develop a rapid test for Procalcitonin(PCT) and S100-β protein in whole blood. They are the first to develop an analyzer which can detect multiple items at the same time with whole blood.
EasyDiagnosis Procalcitonin(PCT) Rapid Test Kit
EasyDiagnosis QFT8000 Fluorescence Immunity Analyzer
Main Markets(International Market)
Top 10 Clients(International Market)
Review
EasyDiagnosis‘s international market sales is ￥85.33 million in 2020, it’s only ￥367,300 in 2019. Their main sales are in the China market, only a few products have CE certification. So you may need to wait for more time or help them to get the certification that your business requires. On the other hand, it may be a good opportunity.
Sansure Biotech | Innovating diagnostics for all
Brief Introduction
Sansure Biotech, established in 2001, is an in vitro diagnostic solution provider integrating diagnostic reagents, instruments and independent clinic laboratory services with its own innovative gene technology as its core.
Sansure Biotech is committed to becoming a genetic technology provider, has developed a series of internationally leading core technologies and more than 400 products with performance exceeding the advanced level at home and abroad. All of the new technologies and products have led the domestic industry to catch up with the international advanced level.
Registration Information
Factory：Changsha City, Hunan Province
Key Products
Sansure Biotech developed world first class high precise Hepatitis B Nucleic Acid Diagnosis kit, and they developed SARS-CoV-2 Rapid Antigen Test (Colloidal Gold Method) in 72 hours. Sansure Biotech sells its COVID-19 test kit all over the world, and now exports the products to over 160 countries, the market share of some countries exceeds 80%.
Sansure SARS-CoV-2 Rapid Antigen Test (Colloidal Gold Method)
Sansure HBV DNA Diagnostic Kit (High Sensitivity)
Main Markets(International Market)
Top 10 Clients(International Market)
Review
Sansure Biotech has a strong ability of research development, they developed the world's leading high precision Advanced Magnetic-beads technology and the first class high precise Hepatitis B Nucleic Acid Diagnosis kit. They developed Six Respiratory Pathogens Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing), which can detect Influenza A virus, Influenza B virus, Respiratory syncytial virus, Adenovirus, Mycoplasma pneumonia, Human rhinovirus in one test. And their website is good, I like it.
Orient Gene Biotech
Brief Introduction
Orient Gene Biotech specializes in the R&D, production and sales of in vitro diagnostic products, belonging to the field of high-end medical equipment and devices. The company has a number of international certifications such as FDA, CE, MDL. Their sales network has been extended to more than 120 countries and regions, and its overseas sales revenue accounted for 95% in 2019. At present, the company has obtained more than 300 overseas certifications/records, and more than 70 domestic registration/record certificates.
Registration Information
Factory：Huzhou City, Zhejiang Province
Key Products
Orient Gene Biotech‘s main products are POCT diagnostic reagents, which are mainly used in the detection of infectious diseases (including COVID-19 detection products), drugs of abuse, fertility, tumor marker and cardiac marker detection. Infectious disease and drugs of abuse detection are the two core product series of the company.
Orient Gene Biotech The Influenza Combo Rapid Test
Orient Gene Biotech One Step Multi-Drug Test
Main Markets(International Market)
Top 10 Clients(International Market)
Review
Orient Gene Biotech has two subsidiaries overseas, one is Healgen Scientific LLC. located in Houston and the other one is Healstone Biotech INC. located in Vancouver. Healgen is a supplier for Siemens‘s COVID-19 antigen detection reagent, the sensitivity(96.72%) of the reagent is great.
Its overseas sales revenue accounted for 95%, the main market for drug testing is in North America. And their HIV and hepatitis C detection kits have passed the highest CE List A certification.
Alltest Biotech
Brief Introduction
Alltest Biotech, which has been operating since 2009, mainly develops, produces and sells in vitro diagnostic reagents. The main products include infectious diseases, drugs, tumors and cardiovascular products. They have FDA, MDSAP, CE, MDL, TGA and Anvisa certificates, which it exports to 100 plus countries.
Registration Information
Factory：Hangzhou City, Zhejiang Province
Key Products
Drug testing products have absolute advantages in the European market. A number of joint drug testing reagents are used in major national laboratories in Russia, and infectious disease testing reagents are used in large government and naval hospitals in Southeast Asia and other regions.
Alltest Biotech Multi-Drug Rapid Test Cassette
Alltest Biotech HBsAg-HCV-HIV-Syphilis Combo Rapid Test
Main Markets(International Market)
Top 10 Clients(International Market)
Review
The overseas revenue of Alltest Biotech accounted for more than 95%, mainly from drug testing and infectious disease testing. The price is a little lower than other companies.
Biotime
Brief Introduction
Biotime, has been operating since 2008, is a hi-tech enterprise that specializes in R&D, production, and sales of POCT in vitro diagnostic devices and reagents. It has 9 product lines with more than 64 individual products.
Registration Information
Factory：Xiamen City, Fujian Province
Key Products
9 products including Progesterone, TSH, and HCG Rapid Quantitative Test(fluorescence immunochromatography) are the world's first fluorescent products.
Biotime Progesterone(PROG) Rapid Quantitative Test
Biotime β-HCG Rapid Quantitative Test
Main Markets(International Market)
Top 10 Clients(International Market)
Review
The quality of Biotime's β-HCG and PROG products has won unanimous praise in the Chinese market. The COVID-19 Self-Test(Rapid Antigen Test) of the Department of Health and Social Care, which is the UK government department, is produced by Biotime.
Hotgen Biotech
Brief Introduction
Hotgen Biotech, established in 2005, based in Beijing, which is a high-tech enterprise focusing on the research & development, manufacture and sales of medical and public safety inspection products of in vitro diagnostics (IVD) in the field of biomedicine.
Hotgen Biotech has developed 8 technology platforms, including bioactive raw material, sugar chain abnormal protein detection (sugar capture), magnetic particles chemiluminescence, up-conversion luminescence technology, colloidal gold, enzyme-linked immunoassay, molecular diagnostics and instrument R&D technology platform.
Registration Information
Factory：Beijing City
Key Products
Its main product lines are inflammation infection, cardiocerebral vascular marker detection.
Hotgen Biotech UPT-3A-1800 Up-converting Phosphor luminescence Analyzer
Main Markets(International Market)
Top 10 Clients(International Market)
Review
The overseas sales is only ￥3.88 million in 2019, increase to ￥316 million in 2020. Their core technology is up-conversion luminescence which has higher sensitivity.
Ustar Biotechnologies
Brief Introduction
Ustar Biotechnologies, founded in 2005, is a leading provider of instant molecular diagnostic overall solutions. Ustar has been focused on rapid nucleic acid diagnostic technology research and application innovation for more than 15 years.
As the first POCT molecular diagnostics enterprise with dual certificates of equipment and reagent of Covid-19 in China, the fully automatic molecular diagnostic system only needs “One Step” operation to realize "sample in result out", without a professional laboratory.
Registration Information
Factory：Hangzhou City, Zhejiang Province
Key Products
Ustar has developed Cross Priming Amplification technology(CPA) and Reagent Vitrification technology and applied them into specific product development. The CPA technology with independent intellectual property rights in China, using multiple cross-linked primers, allows a DNA target sequence to be amplified at a constant temperature.
Ustar Biotechnologies UC0102 Nucleic acid amplification detection analyzer
Main Markets(International Market)
Top 3 Clients(International Market)
Review
The Cross Priming Amplification(CPA) and Reagent Vitrification technology is great, the whole process is integrated, closed and fully automated. The reagent can be transported at room temperature, which greatly reduces transportation costs. No need for expensive molecular laboratories.
Hipro Biotechnology
Brief Introduction
Hipro Biotechnology, established in 2006, focuses on R&D, manufacturing, marketing, and relevant services of Point-of-Care products. Hipro has 50+ products that have received CE certificate, including biochemistry, nephelometry, fluorescence, and turbidimetric reagents, third-party calibrators and controls. Hipro has two wholly-owned subsidiaries, Hipro Biotechnology Co. is located in San Francisco and Hipro Biotechnology GmbH is located in Freiburg, Germany.
Registration Information
Factory：Shijiazhuang City, Hebei Province
Key Products
Hipro‘s main products are infection test kits and specific protein analyzers which are based on nephelometry.
Hipro Biotechnology Hurricane Immunoassay Analyzers
Hipro Biotechnology Procalcitonin (PCT) Diagnostic Tests
Main Markets(International Market)
Top 5 Clients(International Market)
Review
They developed a POCT-specific quality control system which could be traced to ANSI, that's great. Many POCT companies don't have quality control for POCT products. They have developed High precision, high throughput and low cost microfluidics POCT products(CV<2%).
Conclusion
We have highlighted the best rapid test kit brands in China.
I hope you’ve found this guide useful. If you have any questions or tips on locating rapid diagnostic test manufacturers in China, be sure to comment below.
What kind of IVD products suppliers you want to know, comment below. I will write another article for the most mentioned products.
(P.S.: I will update this article every 6 months to keep it as up to date as possible. Save this article RIGHT NOW and be sure to check back frequently.)
转载请注明：Top 10 Rapid Test Kit Suppliers in China: The Definitive Guide | ivdmap
