EUA Authorized Rapid Covid-19 Antibody Test Kits

EUA Authorized Rapid Covid-19 Antibody Test Kits

Since the onset of the COVID-19 pandemic, serology testing has been a key tool in detecting the presence of SARS-CoV-2 antibodies. The affordability and increased improvement in the accuracy of rapid COVID-19 antibody test kits have made them popular among organizations and health centers all over the world.

Antibodies are important in humans when it comes to fighting foreign bodies. The presence of these special Y-shaped protein molecules in a patient’s bloodstream is an indication that the individual has, in the past, experienced a viral infection. Antibodies are disease-specific and, in our case, we are talking about the proteins that fight off coronavirus.

Since the start of the pandemic, nearly 56 serology tests have been granted FDA EUA. Towards the end of September, the U.S. Food and Drug Administration issued an Emergency Use Authorization (EUA) on the first serology (antibody) point-of-care (POC) test for COVID-19. One can now identify individuals with antibodies to SARS-CoV-2 from POC settings such as urgent care centers, emergency rooms, hospitals, or doctor’s offices.

This COVID-19 update comes 7 weeks after the agency authorized the first two COVID-19 antibody tests that display an estimated quantity of antibodies from past SARS-CoV-2 infection present in a patient’s blood sample. The US Food and Drug Administration (FDA), has strict regulations for medical drugs and devices, which is the reason why most organizations and nations all around the world prefer US-manufactured, FDA EUA authorized COVID-19 antibody test kits.  

Coronavirus antibody testing kit developers target different parts of the coronavirus structure. Some of the diagnostic tests for COVID-19 antibodies aim for the nucleocapsid, spike, or both proteins present on the structure of the coronavirus.  The type of technology you are likely to find on these rapid test devices are as follows:

  • Lateral Flow
  • High Throughput CLIA, CMIA, FMIA, ECLIA, and ELISA
  • ELISA (enzyme-linked immunosorbent assay)
  • CLIA (Clinical Laboratory Improvement Amendments)
  • ELFA (Enzyme‐linked fluorescence/ fluorescent assay)  
  • PRI (Photonic Ring Immunoassay)
  • 2-Step ELISA
  • MIA (Magnetic immunoassay)
  • FIA (Fluorescence Immunoassay)
  • Photometric Immunoassay,
  • Semi-quantitative High Throughput CLIA

From the list, most rapid COVID-19 antibody test kits use Lateral Flow technology.  As much as these tests do not detect the presence of the coronavirus, they help identify individuals that have developed an immune response to SARS-CoV-2.

A rapid COVID-19 antibody test kit can be used to determine the prevalence of SARS-CoV-2 antibody-positive individuals in a population.  The percentage of individuals in the population who have antibodies to the COVID-19 virus changes with time, based on the effectiveness of mitigations and the duration coronavirus is in a population.

According to the US Food and Drug Administration (FDA), reliable coronavirus antibody test kits should not be used alone when diagnosing a patient for COVID-19. Since serology tests determine the response of the body’s immune system, it does not show whether the virus is still present.

According to studies, 91% of people will develop SARS-CoV-2 antibodies in the first 4-13 days or 1-3 weeks of the infection. Therefore, it is appropriate to perform diagnostic tests for coronavirus antibodies two weeks after the onset of COVID-19 infection symptoms.

Reliable coronavirus antibody test kits may present negative results during the early days of infection because the immune system is still building antibodies against SARS-CoV-2.  This tool plays a key role in the development of possible treatment for individuals who are seriously ill from the disease.

Healthcare professionals all around the world use EUA authorized rapid COVID-19 antibody test kits to identify individuals with coronavirus antibodies. Some of the people who have developed an immune response to SARS-CoV-2 can donate a part of their blood, convalescent plasma, which is useful in the development of treatment.

Rapid COVID-19 antibody test kits have different performance characteristics and limitations. The technology, Sensitivity (PPA), and Specificity (NPA) may differ from one device to another.  Besides the two performance variables, serology tests are also described by their confidence intervals and positive and negative predictive values.

The result obtained from a COVID-19 antibody test kit can inform on whether an individual had a past or ongoing infection. Scientists rely on ongoing studies on the SARS-CoV-2 antibodies to determine whether a certain level of immunity would prevent re-infection. For now, serology results are useful in identifying the history of infection and distinguishing populations in terms of the body’s immune response to the disease. 

Coronavirus antibody testing kits are used together with a clinical history or diagnostic test results, to identify false-positive and false-negative individuals. These tests are more accurate in high prevalence populations. The accuracy of the test also relies on the user’s understanding of how to test kit works and the interpretation results.

A rapid COVID-19 antibody test kit with high sensitivity and specificity rates should be able to identify samples with or without antibodies to SARS-CoV-2, respectively. If you wish to get accurate results, it is important to check the test’s performance validation. A validation test that uses more samples should give you more confidence with the provided sensitivity and specificity estimates.

Rapid Connect Medical supplies U.S.A. manufactured COVID-19 antibody test kits with accuracy, sensitivity, and specificity rates of 98.20%, 96.25%, and 98.90%, respectively. The best thing about these test kits is that they can detect both Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies.

Rapid Connect Medical can deliver large quantities of Coronavirus (SARS-CoV-2) IgM/IgG rapid test kits for your commercial, biomedical, biological, science, or pharmaceutical needs. All you need to do is contact our sales team and place your order. For more information about our FDA EUA authorized COVID-19 antibody test kits, call us today.

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

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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