Understanding Lab-Based, Point of Care, And At-Home Antibody Test Kits

Understanding Lab-Based, Point of Care, And At-Home Antibody Test Kits - Rapid Connect Medical

The emergency use authorization of antibody test kits issued by the U.S Food and Drug Administration (FDA) on April made private laboratories and large manufacturers rush to develop more test kits to meet the demand. Antibody testing has become a dominant way which global healthcare systems use to test for the coronavirus disease 2019 (COVID-19).

Antibody testing has become a game changer in many nations and has been adopted by organizations wishing to allow their employees to return to the workplace. The routine screening of people that do not develop symptoms for COVID-19 has helped a lot in understanding the spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in a population.

A typical antibody or serological test for CoVID-19 is used to determine whether someone has previously been infected with the coronavirus. This type of screening checks for antibodies to SARS-CoV-2, which are produced by the immune system in response to the viral load in the body.

These antibody tests can be distinguished by the technology or technique used in the design of the kits, and also, they can be differentiated according to where they are intended to be administered. If you wish to define them according to location of analysis, then you are going to find that these antibody tests are categories as either lab-based tests, point-of-care (POC) tests and at-home antibody tests.

Point-Of-Care (POC) Antibody Tests

Point-of-care (POC) antibody tests are also known as pregnancy-style antibody tests, finger prick antibody tests or lateral flow immunoassay (LFIA) tests.  This form of screening is currently popular with companies and some nations in performing diagnostic tests for COVID-19 antibodies. They save the time required to send blood samples to the lab for analysis.

Generally, the POC diagnostic tests for COVID-19 antibodies are devices that use lateral flow technology to detect the presence of IgG, IgM or both in a blood sample taken from a patient suspected to have contracted the virus. The blood sample can either be whole blood, serum or plasma obtained by pricking the finger of a patient.

Antibody point-of-care tests are usually done in the doctors’ office, urgent care clinics and hospital emergency departments, or at the time and place of patient care. They are designed for point-of-care providers such as doctors and other licensed medical professionals. Most companies would prefer to use a point-of-care COVID-19 antibody test kit which are known to provide results in as little as 10 minutes.

Lab-Based Antibody Tests

A typical lab-based antibody test is the enzyme-linked immunosorbent assay (ELISA or EIA). These are tests that need to be done within the confines of in large commercial laboratories or public health labs.  The devices meant for antibody testing in the lab are designed to provide results for two distinct immunoglobulins, IgM and IgG.

All antibody tests including POC tests fall in this category when blood samples are sent to the laboratory for analysis. Lab-based antibody tests are done by scientists and lab technicians to provide an insight of the spread of COVID-19 for research purpose, to judge immunity levels or guide decision making in the medical field.

Sample collection for lab-based antibody tests are mostly done in drive-thru and walk-thru sites. The results to these tests are usually available in within 24 to 48 hours and may take up to a week depending on the lab’s capacity. Lab-based antibody tests use COVID-19 antibody test kits that have very high sensitivity and specificity rates.

At-Home Antibody tests

Last but not the least, there are antibody tests can be administered right from home. The FDA has opened its doors to at-home antibody test kits also known as self-testing antibody kits. At the moment, the agency has not issued an emergency use authorization on any at-home antibody testing device. The only EUA available is for at-home collection kits which come with guidelines for the development of such kits.

The reason why we are not seeing the use of at-home antibody could be due to the tough guidelines laid out by the FDA. Also, most experts see this method to be one that is prone to errors especially in areas such as handling and collection of samples for the testing.  They will be facing the same challenges that at-home sample collection is facing.

Most reviewers and experts believe that the use of at-home testing could be the best solution to achieve the recommended rate of positivity or positivity rate (5% or lower for at least 14 days) before reopening. Even with the expected challenges, many companies are working on at-home diagnostic tests for covid-19 antibodies. At-home testing will help a lot in figuring out the total spread of infection in a population.

Conclusion

The three types of tests can not be used solely to diagnose for coronavirus, they must be confirmed by another method, usually the polymerase chain reaction (PCR) test. Consumers are warned to be on the lookout not to purchase coronavirus antibody testing kits that are not approved by the FDA.  With the increase in demand for screening manufacturers are doing their best to develop accurate serological tests.

Unapproved medical devices put public health at risk by providing false results which may allow infected persons to continue interacting with the rest of the population.  Reliable coronavirus antibody test kits (lab-based, point of care, and at-home) are easy to identify, the FDA EUA approved come with the agency’s logo while those that target the European Economic Area (EEA) come with the CE marking.

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.

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 https://rapidconnectmedical.com/

Stop the Spread – Test Yourself Now

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