The U.S. Food and Drug Administration (FDA) has so far publicly posted test performance data for more than 30 antibody test kits since it declared a EUA on serology testing. This type of data is only available after a validation study is done on rapid COVID-19 antibody test kits. The need for such vital information is to verify the accuracy of the manufacturer’s test kit data.
The FDA conducts its independent validation study with the help of the National Institutes of Health’s National Cancer Institute (NCI). The agency’s performance validation effort makes use of additional data from the coronavirus antibody testing kit to guide on the final decision before they publish their findings on their website.
Validation studies are also performed by government institutions in various countries around the world. For instance, in India, the ICMR is responsible for issuing guidance on rapid antibody test kits for COVID-19. Independent laboratories and organizations also participate in the study of the diagnostic tests for COVID-19 antibodies currently in the market.
The FDA shares the performance data of every COVID-19 antibody test kit it tests to provide reliable information to the wider research community. By posting the data to the public, the agency aims to help people get access to trustworthy test kits. It also protects the public health by assuring that only safe, effective, and secure medical devices are available in the market.
The need for the publication of serology test kit performance data comes at a time when the market is flooded with fake antibody kits. This abuse of opportunity came as a result of the declaration of the EUA on antibody tests that allowed manufacturers to distribute their products before a review is done to meet the demand for mass testing.
Governments around the world have discovered the need to determine the efficacy of the many tests on the market to avoid purchasing devices that produce dubious results. Nations rely on performance data to guide on decision making, whether to use antibody testing as a strategy to curb the spread of the Covid-19 virus.
From the performance data published by the FDA, you are going to find information such as:
- The name of the developer
- The type of the antibody test kit
- The technique used in the design of the test kit (Lateral flow, ELISA, MIA, CMIA, FMIA, CLIA or ECLIA)
- The parameters measured (Confidence Interval, sensitivity, specificity, accuracy, and PPV or NPV at prevalence)
- The targeted structural protein of the antigen (Nucleocapsid, Spike, or both)
- The type of antibody under study (IgG, IgM or both)
The FDA evaluation study takes into consideration the antibody tests that are subject to Emergency Use Authorization (EUA) or pre-EUA and those that the agency wishes to review independently.
Scientists rely on publicly published performance data of antibody kits to understand how the device operates under different conditions. Knowing how the COVID-19 antibody test kits perform has helped in understanding how timing and other factors affect the final results. Understanding the performance characteristics and limitations will also help inform on how to use the COVID-19 antibody test kits properly.
There is a need to guarantee the efficacy of the COVID-19 antibody test kits because any chances of false-negative or false-negative results can greatly undermine the efforts laid in place to curb the spread of Coronavirus. Results obtained from the antibody or serology test reveals the know the prevalence of SARS-CoV-2 antibody-positive individuals in a particular population under study and their level of the immune response to the infection.
Positive results from diagnostic tests for COVID-19 antibodies show that an individual had previously been infected by the disease. The type of antibody also determines whether the body is still fighting the coronavirus or the patient has fully recovered from it.
Scientists are looking to use a portion of the blood, convalescent plasma, of individuals who have tested positive for COVID-19 antibodies to come up with treatment. Currently, the world is waiting for clarification on whether recovering from COVID-19 and developing antibodies against the disease-causing virus is a guarantee that humans are immune to future infections.
With this in mind, it rings a bell why there is a need for reliable coronavirus antibody test kits where an antibody or serology test is the best strategy in place to prevent the spread of the COVID-19 virus. The presence of accurate COVID-19 antibody test kit performance data can influence the use of these medical devices to help conserve crucial molecular diagnostic testing supplies, which are of high demand during this novel coronavirus pandemic.
Rapid Connect Medical, a key player in the distribution of Reliable Coronavirus Antibody Test Kits, publishes COVID-19 antibody test kit performance data on its site. The data has been verified by the FDA, the National Cancer Institute, and the World Health Organisation agency. If you are looking to make a large purchase of Coronavirus (SARS-CoV-2) IgM/IgG rapid Test Kits online, then you are a click away from getting accurate results using the most innovative solution.
Feel free to contact Rapid Connect Medical’s rapid-ship response team and make your bulk test kit orders with ease.
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 quantities, 25 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.
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 https://rapidconnectmedical.com/
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Stop the Spread – Test Yourself Now