COVID-19 Antibody Test Kit Performance Data By FDA

COVID-19 Antibody Test Kit Performance Data By FDA - Rapid Connect Medical

The U.S. Food and Drug Administration (FDA) is mandated to do a validation study before they authorize any COVID-19 antibody test kit for use under the EUA (Emergency Use Authorization) umbrella. The study determines the performance of the test kits and the data is then shared publicly.

Previously, the manufacturers of rapid COVID-19 antibody test kits were allowed to distribute their products without the FDA review to promote mass testing. What they were required to do was to do their own valid testing and submit the results to be review by the agency. The presence of false positive and negative made the government shift to ensure that the efficacy of the tests on the market is reliable.

FDA validation

The FDA’s independent performance validation is done with help from institutions such as National Cancer Institute (NCI), a National Institutes of Health’s agency, Centers for Disease Control and Prevention (CDC) and Biomedical Advanced Research and Development Authority (BARDA). Besides the collaborative effort of the FDA, NIH, CDC and BARDA to evaluate serological tests, there are other institutes that are tasked with the supply of essential reference samples and materials. 

The validation tests were made at the Frederick National Laboratory for Cancer Research (FNLCR). The FDA reviews the proposed antibody, or serology, test kits and determines if any further action is required before the kits are available for publication. The first performance data from an antibody test kit went public on May 4, 2020, and since then the FDA has been shared data from additional tests. This type of independent testing is only done by US government laboratories.

From 2020 to present, the U.S. Food and Drug Administration (FDA) has tested more than 35 coronavirus antibody testing kits and approved eight COVID-19 antibody test kits. Most of the antibody tests subject to an Emergency Use Authorization (EUA). Some of these kits are for COVID-19 antibodies detection through ELISA (enzyme-linked immunosorbent assay) test, while the rest require the use of an IgG/IgM Rapid Test Cassette.

Coronavirus Antibody Testing Kit Sample Selection

During the evaluation process, the sample (positive and negative), sample size and panel size is determined. The Emergency Use Authorization (EUA) sample size is used in this antibody kit performance test. The agency uses EUA approved enzyme-linked immunosorbent assay (ELISA) tests to confirm the presence of IgM and IgG antibodies in the samples.

The positive samples come from patients that are confirmed to having SARS-CoV-2 infection by a nucleic acid amplification test (NAAT). These samples are usually diluted before they are tested for the presence of antibodies against coronavirus on their Pan-Ig, IgM and IgG assays. All positive samples used in the evaluation test were positive for both IgM and IgG at a dilution of 1:6400.

The validation uses samples marked “negative” which were collected before coronavirus was known to have circulated in the US without regard for clinical status. These samples showed reactivity in the Pan-Ig CDC spike and IgG RBD ELISA at the laboratory.

Some samples negative samples were selected from a bank of serum from HIV+ patients, to identify any possibility of cross-reactivity and to increase and reduce the sample size and confidence interval, respectively.  These samples were also diluted and assessed on their Pan-Ig, IgM and IgG assays. All negative samples used in the evaluation test were negative for both IgM and IgG at a dilution of 1:100.

COVID-19 Antibody Test Kit Validation Analysis

During the analysis, sensitivity (PPA) and specificity (NPA) were calculated for each antibody separately or as a combination where multiple antibodies were measured separately in a test. Any ambiguous results from the ELISA tests for sensitivity and specificity calculations was counted as false negative and false positive results on positive and negative samples, respectively.

In the sensitivity and specificity analysis, the confidence intervals were calculated per the CLSI EP12-A2 score method. The score method described by Altman was used to calculate the confidence interval for the difference in false positive rates.

The evaluation procedure takes into consideration the antibody test kit manufacturer’s terms of use and storage, the ELISA test conditions and the lateral flow test. The validation testing was performed in a non-clinical laboratory environment and the personnel or operator who performed the testing was trained to use the kits and undertake the task.

Advantage of FDA Performance Test Data

The importance of sharing the performance data of serology tests by the FDA is to advance the knowledge or the wider research community and to ensure that Americans get access to trustworthy tests. These agencies take advantage of their laboratories capacities and expertise to help understand the performance of antibody tests. 

In terms of rapid COVID-19 antibody test kits, the FDA does the validation or performance test with the aim of protecting the public health by assuring the safe, effective, and secure medical devices. Generally, FDA relies on the performance data for decision making. Health organizations and professionals rely on the FDA COVID-19 antibody test kit performance data to determine the potential benefits or risks of the device.

It is important that one should first understand the performance characteristics and limitations of coronavirus antibody testing kits before using them. For instance, diagnostic tests for COVID-19 antibodies should not be used alone because it may be hard to detect these virus fighting proteins during the early days of an infection when the body is still building its defense.

Rapid Connect Medical is an exclusive distributor of the FDA EUA authorized rapid COVID-19 antibody test kit. If you are an organization or a healthcare professional looking for reliable coronavirus antibody test kits to identify individuals who may have developed an immune response to coronavirus, SARS-CoV-2, then you are safe with Rapid Connect Medical as your antibody test kit partner.

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.

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 98.23% 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.

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

Stop the Spread – Test Yourself Now

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