Top Agencies That Approve the Use of Antibody Tests for COVID-19

Top Agencies That Approve the Use of Antibody Tests for COVID-19 - Rapid Connect Medical

Nations and health care providers fighting the COVID-19 pandemic rely on a variety of tools to diagnose the disease, and one of them is antibody testing. The coronavirus disease is widely spreading and claiming lives every single day. Several measures are in place to mitigate this spread including keeping a good social distance, washing hands regularly and maintaining personal health. 

Diagnostic tests for COVID-19 antibodies have proven to be important in cases where individuals fail to show symptoms of the disease or when the infected persons have fully recovered. The increase in demand for testing forced the FDA to issue an EUA (emergency use authorization) for SARS-CoV-2 antibody assays – lateral flow or enzyme-linked immunosorbent assay (ELISA) tests. 

Issuing an EUA on antibody testing has seen the introduction of new medical products in the US market from manufactures and laboratories all around the world. The shortcomings of using unapproved antibody tests leads to false results, a factor that can further increase the spread of COVID-19. For this reason, the FDA revoked the EUA for all COVID-19 antibody test kits; replacing it with Individual EUAs. These inaccurate test kits have also been removed from the FDA EUA website.

FDA can only revoke the emergency use authorization (EUA) of a Covid-19 antibody test if the accuracy of the test is in question. The agency independently gathers data regarding the performance expectations of these medical tools. These adjustments are only made to tests that generate a higher than expected rate of false results – false positive and negative readings and interpretation of the tests. 

Antibody tests that are likely to produce false-positive results are considers to have a low sensitivity rate. They are not accurate in the sense that they can be influenced by cross reactivity, hence producing results suggesting that someone without the virus is positive for the disease. False-positive results leads to unnecessary further testing, isolation, and contact tracing and treatment; which comes at an extra cost.

Leading agencies in the fight against the novel coronavirus advise against diagnostic tests for COVID-19 antibodies that provide false negative results.  The worst thing about these types of results is that they reassure people who have contracted the disease that they are coronavirus free. This situation hinders the efficiency of contact tracing, and isolation and treatment; hence potentially placing public health at risk. Proper testing helps doctors treat patients in a timely manner.  It also appears that regular testing will let a patient know when it is safe to leave quarantine.

Companies misusing the umbrella EUA for Coronavirus Antibody Tests might have introduced fraudulent devices claiming to detect antibodies of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).  Some companies were found marketing misbranded and adulterated serological tests. They had falsely labelled their products as FDA-approved and included the agency’s logo on them.

Coronavirus antibody testing kits sold within the US territories will require an individual FDA EUA approval. On the other hand, Covid-19 Antibody Test Kits approved for sell within the European Economic Area (EEA) will require a mandatory CE (Conformitè Europëenne) marking.  This type of certification mark confirms that the device meets EU’s safety, health and environmental protection requirements.

For the FDA EUA approval, coronavirus antibody testing kits from various manufacturers must fulfil the agency’s criteria for issuance of authorization requirements for validation. Here, the estimates of the sensitivity (Positive Predictive values), specificity (Negative Predictive values) and Confidence Intervals antibody test are estimated for individual or combined target antibodies (usually IgG and IgM). 

Reliable coronavirus antibody test kits provide genuine logo or certification markets from national authorities. Most of the antibody tests in the market come with the FDA logo and the CE marking, and the ones without these marking are more than likely fake. It is important for the buyer to learn how to identify genuine approval markings from certain national authorities.

The importance of having agencies that approve the use of medical devices such as the rapid COVID-19 antibody test kit is to prevent the public from further infection. The regulation of medical products all around the world vary from one country to another and one region to another. Developing countries rely on medical device regulatory authorities in established countries such as the USA and Europe. 

Finding rapid COVID-19 antibody test kit solutions for your company should not be a difficult task. Partnering with Rapid Connect Medical gives you access to innovative and reliable FDA EUA approved and CE certified antibody test kits that guarantee quick and accurate results. 

Feel free to contact Rapid Connect Medical’s rapid-ship response team for more information about rapid COVID-19 antibody test kits and how you can make your bulk order today. 

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.

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.

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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