USA Made Versus Chinese Made Antibody Test Kits

USA Made Versus Chinese Made Antibody Test Kits - Rapid Connect Medical

WHO recommends the use of a “testing, isolation, and contact tracing” strategy to help curb the spread of the novel coronavirus. New and established manufacturers, within and outside the medical field immediately started producing testing kits to meet the demand for mass testing in nations and organizations all around the world.

You can now get your coronavirus antibody testing kit from biotech companies and research laboratories in countries such as the US, China, Israel, South Korea, Canada, Japan, and Germany. The design of the antibody test kit components may differ from one country to another, but the technology is the same, Lateral flow technique.

Early in the year, the U.S. Food and Drug Administration (FDA) issued a EUA (emergency use authorization) for the detection of antibodies to SARS-CoV-2.  The US and China are two of the top countries that host a great number of companies that manufacturer antibody test kits. These tests test early infection and they can provide a history of the previous COVID-19 infections.

Antibody or serology tests are designed to detect the presence of antibodies against the COVID-19 virus in the blood of a patient. Besides giving a history of coronavirus infection, these tests can also be used to determine the body’s immune response to SARS-CoV-2. Individuals that test positive for coronavirus antibodies can donate a part of their blood, convalescent plasma, to be used in the development of treatments.

Antibody or serology tests are recommended to asymptomatic individuals and also those who have recovered from the COVID-19 virus.  This testing method aims to determine the immunity of the human body against coronavirus infection. Some researchers are using the results from the antibody tests to determine the extent of the infection in a population.

Accurate results are used to guide decisions on whether people that have tested positive for antibodies can donate their convalescent plasma, for treatment or the results can be used to relax social-distancing measures and allow people to travel and go back to work. According to WHO, these point-of-care tests should only be used for research and by licensed medical professionals as tools for tracking the spread of the disease in the community.

Most Nations that order rapid COVID-19 antibody test kits have regulatory authorities that provide clearance of the device. For instance, in India, the Indian Council of Medical Research through the National Institute of Virology (NIV) determines which are reliable coronavirus antibody test kits. Manufacturers in the US rely on the FDA for the validation of their test kits, while in Chinese made antibody kits have to be certified by China’s National Medical Products Administration (NMPA).

In the US, companies marketing rapid COVID-19, antibody test kits are required to obtain individual FDA emergency-use authorizations. The U.S. FDA has approved a significant number of rapid COVID 19 antibody test kits from American and Chinese manufacturers. All testing kits design for the American market come with an FDA logo to verify that they have been authenticated by the American authorities.

On the other hand, diagnostic tests for COVID-19 antibodies manufactured in china are validated by the Chinese authorities. Most of the Chinese coronavirus antibody testing kits are sold in Europe, Latin America, and Asia. However, there are complaints that some manufacturers are taking advantage of the pandemic to market fraudulent devices.

Indian states using the Chinese equipment have complained of conflicting results coming from COVID-19 antibody test kits imported from China. There are reports of many European countries rejecting and sending back substandard Chinese-made test kits. The use of substandard medical devices is known to produce dubious results that can endanger people’s lives.

Testing accuracy variations are present when the testing devices are not transported, stored, or used per the product requirements provided by the manufacturer. The false data could also be a result of virus mutation, methods of validation, and quality control. Generally, these devices are designed for use by professionals only.

The difference between the Chinese made and US-made antibody kits is quality and accuracy. More than five countries have complained of defective and dubious antibody kits coming from China. Independent trials of these devices have shown an accuracy of less than 50%. From these weaker results, one can say that Chinese made antibody kits have low accuracy.

You may be interested to know that most of the ‘USA made antibody test kits’ come from Chinese factories, and they come relabeled to make them look as if they were made in the US.   This has led to many companies in America withdrawing their connections with Chinese manufacturers due to the bad reputation of the kits that come from this country.

Most Chinese made antibody test kits are repackaged with different brand names in the countries that import these devices. Also, you can’t ignore cases where these diagnostic tests for COVID-19 antibodies are sold directly to non-healthcare professionals by retailers online. Most Chinese made antibody test kits are bought through third-party companies or resellers from other countries. A great number of them come from companies in China that have little to no background in the medical testing industry.

The USA made antibody Test kits are subjected to strict scrutiny from the U.S. FDA. The results provide information on the clinical trials done such as the clinical state of the patients, ethical approvals, and all fundamental aspects used to identify reliable coronavirus antibody test kits. The Agency’s regulations leave no room for errors.

There are many claims that the Chinese made antibody test kits are substandard but that is not always the case there are some that have passed the FDA EUA validation process. However, most buyers opt for the USA made antibody test mainly because of the trust that they have on the FDA approved medical devices. 

At the moment, the world is waiting for the ultimate good antibody testing kits, devices that have more than 99% accuracy. If you wish choose USA made antibody test kits, then Rapid Connect Medical has you covered.

Just in case you are wondering where you can place your COVID-19 antibody test kit order; Rapid Connect Medical has in place a rapid-ship response team ready to handle your test kit orders. Contact us today if you have any questions.

Rapid Connect Medical is now offering a U.S.A. manufactured, FDA EUA Authorized Covid-19 antibody rapid test kit.  This antibody test kit is on sale for 50% off it’s normal price for the month of August. These 25 test kit packs is to be administered by a licensed medical professional.

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 order 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

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Stop the Spread – Test Yourself Now

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