Top Countries That Manufacture FDA Approved Covid-19 Antibody Test Kits

Top Countries That Manufacture FDA Approved Covid-19 Antibody Test Kits

Manufacturers and laboratories all around the world have joined the fight against the spread of Coronavirus disease 2019 (COVID-19). These developers seek to supply governments and organizations innovative and accurate solutions that help understand and mitigate this pandemic. These tests are used in undertaking small to large COVID-19 serological surveys.

When scientists became interested in the SARS-CoV-2 antibodies, manufactures and independent laboratories rushed to develop COVID-19 antibody test kits. The market is believed to be flooded with serology testing kits coming from countries that have approved this type of testing technique.


China is one of the countries that has most of the companies that distribute COVID-19 antibody test kits around the world. Medical products coming from this country are licensed by the Chinese National Medical Products Administration.

Chinese firms such as Beijing Wantai Biological Pharmacy, Hangzhou Laihe Biotech, Hangzhou Biotest Biotech, Xiamen Biotime Biotechnology, and Assure Tech. (Hangzhou Co., Ltd) have been approved by the US Food and Drug Administration (FDA).

COVID-19 antibody test kits in China are developed by university medical schools, independent laboratories, and manufacturers from the medical industry and other industries. in this country, these kits are approved by the National Medical Products Administration (NMPA). The Chinese Rapid COVID-19 antibody test kits have been sold to countries such as Spain, India, Italy, and the United Kingdom.

United States of America

Many countries and organizations select the United States as the best destination to offset shortages of clinical laboratory SARS-CoV-2 test kits. The US coronavirus antibody testing kits are certified for manufacture, sale, and use by the FDA. One of the destinations for these American products is the Italian market.

Most of the antibody tests developers that supply in the US market have been reviewed and approved by the FDA. These manufacturers include Abbott Laboratories, Siemens Healthcare Diagnostics, Babson Diagnostics, Cellex, Access Bio, Healgen Scientific, Luminex Corporation, Bio-Rad Laboratories, Diazyme Laboratories, Beckman Coulter, InBios International, Emory Medical Laboratories, Ortho-Clinical Diagnostics, Vibrant America, Wadsworth Center, Megna Health and Mount Sinai Hospital.


Germany became one of the first European countries to do large-scale COVID-19 antibody testing. This country produces most of its test kits for national use. Here, medical products are regulated by Germany’s Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte or BfArM).

The German antibody test developer that has been authorized by the FDA to supply the US market is EUROIMMUN. Products made by Germany have found use in Ireland and among other countries that plan to do seroprevalence surveys.


In April 2020, Finland started a randomized antibody testing to determine the spread of the virus in the country. Most of the test kits for antibodies against SARS-CoV-2 made in this country are used internally. National Supervisory Authority for Welfare and Health (Valvira) is in charge of regulating medical devices in Finland.

Finish developers that have been approved by the FDA to supply the US market include Biohit Healthcare and Salofa Oy. The University of Helsinki is also a key player in the development of an antibody test for the novel coronavirus in Finland.


In France, the authority responsible for the regulation of medical devices is the Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM). Test kits need to have a CE marking for them to be accepted in France. Covid-19 antibody tests in France can be carried out in pharmacies. The only French rapid COVID-19 antibody test kit developer that has been approved by the FDA to supply the US market is bioMérieux SA.


Italy manufactures diagnostic tests for COVID-19 Antibodies to be used in its campaigns and large-scale surveys. The National Health Institute is in charge of regulating the manufacturing and marketing of antibody test kits in the country.  Some of the markets for the Italian covid-19 antibody test kit include Belgium, Israel, and Germany.

The only Italian Coronavirus Antibody Testing Kit developer that has been approved by the FDA to supply the US market is DiaSorin. TechnoGenetics is also a key player in the supply of antibody tests in Italy.


Just like Germany and Italy, Switzerland too launched country-wide antibody tests. This shows that most of these products are used within the country. The only Swiss COVID-19 antibody test developer that has been approved by the FDA to supply the US market is Roche. The country supplies its antibody test kits in the United Kingdom.

Most nations interested in diagnostic tests for COVID-19 antibodies aim to estimate the percentage of people in a population who have developed SARS-CoV-2 antibodies. They are used as testing tools in COVID-19 seroprevalence surveys and studies. They can be used to monitor the infection rate of a population.

The results from these antibody kits provide relevant information on the proportion of people who have experienced a recent or past infection. These findings inform decisions that can help prevent the spread of the virus. Better results are obtained in critical and high-risk populations, areas that have high COVID-19 infections where most of the people are asymptomatic.

Reliable coronavirus antibody test kits offer the best specificity and sensitivity rates for both the IgG and IgM antibodies. Governments, companies, and Institutions looking to re-open rely on the accuracy of these test kits, where a sensitivity and specificity 100% is required.  Antibody testing has not yet been approved for general use; it has been designed for use by healthcare personnel. Most countries are considering the “immunity passports” as part of their strategy to reopen their economies.

As of the end of August 2020, these seven are the only countries with one or more manufacturers that market FDA approved COVID-19 antibody tests.  When need reliable coronavirus antibody test kits in bulk and at an affordable price, you should make Rapid Connect Medical your trusted partner.  Feel free to contact Rapid Connect Medical to learn more about the test kits and how to place your large order.

A range of affordable mass screening point-of-care tests are available on order from different authorized distributors such as Rapid Connect Medical. This company allows companies and investors to make bulk test kit orders through its rapid-ship response team. If you would like to get more information on the testing capability of their covid-19 antibody test kits, feel free to contact Rapid Connect Medical and place your order today.

The sampling done with the rapid COVID-19 antibody test kit cassette using lateral flow from Rapid Connect Medical will give you the IgG and IgM detectable diagnostics results from between two and ten minutes. It can be used for reference in combination with the results from an RT-PCR (reverse transcriptase-polymerase chain reaction) test. A single finger prick to draw blood can be used with our kit that detects antibodies.  This positive or negative result can be detected as soon as 3 days after exposure to COVID-19 (sometimes before the onset of symptoms occur).  Knowing if you have active igM antibodies even in the first week of infection can help get the best treatment for an infected person.

If you do test positive, potentially exposed, or have traveled to a region with high infection rates, you should seek care from your doctor for treatment and continue to test for IgG antibodies daily until you are cleared to leave quarantine. The sensitivity, specificity, and accuracy or our antibody test kit is very high.  This testing method for the public gives real time results and helps to identify initial infection before the severe flu like symptoms begin.  This kit is intended to be administered by a health care professionals and providers at a clinic or other health care facilities.  Many of the faulty test kits were removed from the FDA EUA website; all of our test kits are authorized by the FDA and their data appears and is included on that website.  Consumers can trust the validity and quality of the antibody test kits sold by Rapid Connect Medical.

The kits used for diagnostic tests for COVID-19 antibodies are usually designed for research use or qualitative detection of coronavirus, and not home use. Also, they can only be used to test the presence of IgG and IgM antibodies against SARS-CoV-2. Since they are aiding tools to RT-PCR or CT scanning, a clinical diagnosis of COVID-19 should be done by a healthcare professional or physician.

An antibody detection test cassette contains antigens from SARS-CoV-2 combined with gold nanoparticles. The device has two wells (one for specimen and one buffer) and a control region on the upper end.  Two types of antibodies are of great importance in diagnostic tests for COVID-19 antibodies: Immunoglobulin M (IgM) and Immunoglobulin G (IgG). 

The importance of the gold nanoparticles in the detection test cassette is to create a colored line in the control region.  Antigens targeting a specific antibody are located in their respective regions on the nitrocellulose membrane of the test cassette. The IgG and IgM regions are coated with anti-human antibodies for each. 

The rapid COVID-19 antibody test kits you will find on the market are designed to detect SARS-CoV-2-specific antibodies. The ones distributed by Rapid Connect Medical are FDA research approved and evaluated and validated by a comprehensive clinical study.  This antigen test kit was developed in response to the COVID-19 global pandemic and offers a power tool for health care providers.  The immune response produced by a Coronavirus viral infection is what this test measures.  The CDC testing standards for laboratories were strictly followed during the clinical trials for our antibody test kit.

This is a serology elisa based test for SARS-CoV-2 antibodies in serum or plasma components of blood. Information on the collection data, total sample size, and validation of lab samples can be found here for review.  Interpretations of test results should be confirmed with a lab and a a medical professional should diagnose your infection status not only on the sole basis of your rapid test kit results.  This rapidtest should be performed by a licensed medical professional and your infection status determination may require additional tests.  With the presence for IgG antibodies people can have immunity for some time.  While viruses such as influenza have been a problem in the past, Covid-19 is a serious problem we aim to help eliminate.

Rapid Connect Medical distributes large orders of Coronavirus (SARS-CoV-2) IgM/IgG rapid test kits to global professional sports league and arenas. Rapid Connect Medical is the leading provider of Covid-19 Antibody test kits in small quantities25 test kit packs, as well as bulk orders for large countries, companies, and organizations.  If your institute or corporation is in the need of antibody test kits, feel free to email our sales team.  The company covers the USA, Canada, South America, and European territories. Therefore, if you are from these areas, Rapid Connect Medical will be able to assist you with availability, pricing, and ordering. Our test kit is considered to be the best product on the market for rapid Covid-19 antibody testing.

Our test kits are FDA EUA (Emergency Use Authorization) Authorized, have the CE Declaration for authorized European Union distribution, and have an authorization for use by the HHS for Pharmacies and Pharmacists.  Federal guidance has been issues for Rapid Connect Medical’s COVID-19 Antibody test kit that is 98.20% accurate with results in 2 to 10 minutes.  Don’t take a risk using inferior test kits, our Antibody Test kits are tested in a biotechnology laboratory!  The development of the technology for this screening standard with confirmed scientific accuracy is unique to Rapid Connect Medical‘s Antibody Test Kit.

If you are interested in ordering a large quantity for commercial, biomedical, biological, science, or pharmaceutical applications and have questions, feel free to book a call with our sales team.  In response to the global demand, our manufacturers have the capacity to support your required production needs.  Covid-19 testing is also covered by many insurance plans.  For our update on insurance coverage from our website, that can be accessed here.  Our newest test kit also has data from specimens collected by the Mayo clinic.

Important Features:

Certification and Authorization – COVID-19 antibody test kits from Rapid Connect Medical are safe for use under the Emergency Use Authorization (EUA) of the FDA (Food and Drug Administration). They also are authorized by The U.S. Department of Health and Human Services (HHS) for Pharmacy or Pharmacist use. The antibody test kits come with a CE Declaration, meaning that they are clear for use in countries that fall under the European Union. 

Storage and Quality – the Coronavirus antibody testing kits from Rapid Connect Medical have a shelf life of 24 months from the date of manufacture. 

Ease of Use – the COVID-19 antibody test kits from Rapid Connect Medical are easy to use and you can get your results in two to ten minutes. The antibody test kits are designed for medical professional use and not as an over-the-counter product for home use. 

Technology – the rapid serologic COVID-19 antibody test kits from Rapid Connect Medical use lateral flow technology. 

We offer fast shipping methods for our antibody test kits at an affordable rate. You can order test kits online at

Be sure to follow us on Facebook, LinkedIn, YouTube, and Twitter for updates, news, and new product announcements.  We will also be having press events in the near future so keep an eye out for more news about Rapid Connect Medical!

Stop the Spread – Test Yourself Now

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