FDA Approved Rapid Test Kits

FDA-Approved Rapid Test Kits

Presently, there are many rapid test kits at your disposal for detecting COVID infection but be careful since all of them are not FDA-approved rapid test kits. Many of the kits you find at a low price and effortlessly may not be a licensed product, and in opposition to a diagnosis, you may be infected using them.

The U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorizations (EUAs) for several COVID-19 rapid test kits. Some of the test kits like OTC(over the counter) are for domestic purposes and a few such as POC test kits are applicable to carry out at a testing center only.

The FDA-approved rapid test kits are used for determining the proteins from SARS-Cov-2 only, and not for detecting any other viruses or pathogens. And in this article, we will uncover various FDA-approved rapid test kits.

But before discussing different rapid test kits, why not learn about the rapid test and how many types of rapid tests can be performed?

Types of COVID-19 Rapid Tests

Although there are several ways of testing COVID, here we disclose only two types of COVID-19 rapid tests: antigen tests and antibody tests.

These tests are FDA approved to conduct anywhere across the American region. So, stick with us.

Antibody Tests: The antibody test detect the presence of antibodies in the blood, which is produced by the body’s immune system in reaction to a viral infection. They are used to find out an active infection, or if an individual has been infected with the particular virus in the past. Antibody tests are also effective in finding whether a person has received an immunity injection meanwhile the results can take several days to be available.

Antigen Tests: Antigen tests determine the structural features or small proteins that make up the virus, or simply they detect the presence of the virus itself. They are performed by taking a nasal or throat swab to diagnose a  functioning contagion. Though the results are quick and generally possible within 15-30 minutes.

However, antigen and antibody tests are less sensitive and accurate than PCR tests.

COVID-19 Antigen Rapid Tests

Mainly two distinct antigen rapid tests are performed around the world, Rapid Antigen Tests and Point-of-care(POC) antigen tests.

Rapid antigen tests are usually lateral flow assay test that uses a sample of fluid such as blood, saliva, or mucus to detect the presence of a specific antigen like the SARS-Cov-2 virus that causes COVID-19. It is an FDA-approved rapid diagnostic test that does not require a specialist, can be obtained over the counter, provides results in under 15-30 minutes, and you can conduct it at home, in a clinic, or office.

In like manner, POC antigen tests are also a type of rapid diagnostic test designed to apply to a large number of people at a designated testing premise which uses swab samples from the nasal cavity or throat. These tests are carried out by trained personnel or healthcare professionals, are FDA approved to perform, and they too provide quick results in about 10 to 30 minutes.

After the quick information about the COVID-19 diagnosis ways and tools, let us understand how effective and accurate these FDA-approved test kits are.

Lists of FDA-Approved Rapid Test Kits

As mentioned before, you will find many FDA-approved COVID-19 antigen rapid test kits freely accessible on the market which are issued to use under Emergency Use Authorization. Here is a list of a few of the FDA-approved rapid test kits.

However, it is crucial to note that these are only a few examples of the rapid antigen test kits that are available to you. Every now and often, new kits are added to the list as they are permitted by the FDA.

Likewise, not all the kits are available for purchase by the general public, some of them are exclusive and only meant for use in professional settings.

Therefore, it is always a good notion that you check out the FDA’s official website, before arriving at any conclusion, for the most up-to-date information on COVID-19 antigen rapid test kits that have been granted Emergency Use Authorization.

Flowflex FDA-Approved Test Kit

Flowflex FDA-approved test kit is one of the best rapid antigen COVID-19 at-home test kits designed by the Flowflex corporation in response to the Coronavirus pandemic. It is an authentic and swift self-test kit that is very handy to apply.

Flowflex antigen rapid test kit can be obtained at your neighboring medical facility without a doctor’s prescription. What’s more, it is suitable to use at any location and is useful to administer to children above 2 years as well. You can exercise the test as per your comfort and self-diagnose the COVID-19 infection using your nasal swab in under 15 minutes.

Salocor POC COVID-19 FDA-Approved Test Kit

Salocor POC rapid test kit is also an antigen testing tool that identifies the Coronavirus pathogens in a person’s nasal or throat swab sample. However, the key difference in regard to other testing instruments is that these FDA-approved rapid test kits can only be operated by trained healthcare professionals at a testing health facility or an authorized center.

Still, they are remarkably effective, significantly accurate, and can be applied to a large population in a short period. Plus, these tests provide more speedy outcomes than at-home tests.

Furthermore, you can contact us if you require Flowlfex FDA-approved test kits or Salocor POC COVID-19 antigen test kits. SVI Medical Group distributes various OTC and POC antigen rapid test kits, masks, PPE kits, etc. all around the world at a reasonable price.

How Accurate are FDA-Approved Rapid Test Kits?

A certain infection experiment tool getting FDA approval already signifies that the test kit has gone through various testing itself before being released into the world for general usage.

FDA conducts trials for all of the rapid test kits that come for licensing and ascertains their sensitivity and accuracy overall with all the floating variants. The efficiency of the test kits is compared with a more effective PCR test several times taking all the COVID-19 variants under observation. If the results come out highly positive, only then are the testing tools issued by the FDA to use under EUA.

Hence, FDA-approved rapid test kits are highly accurate and can be performed without fear. Most of the FDA-approved at-home test kits are over 80% accurate and similarly, POC test kits are 95-97% authentic to take advantage of.

Advantages of Rapid Test Kits

Rapid test kits have several benefits, including:

Convenience- Rapid test kits can be used in a variety of settings according to your well-being. This means that people can be tested closer to where they work or live, which can significantly increase testing accessibility. And as OTC kits can be self-administered, it reduces the burden on centralized testing facilities.

Speed- In opposite to PCR or laboratory-based tests, FDA-approved rapid test kits can produce results in a matter of minutes. This enables quicker diagnosis and treatment of infected individuals, as well as more productive contact tracing and isolation of exposed people.

Cost-effectiveness- Evidently, rapid test kits are far less expensive than laboratory-based tests, which makes them more accessible to people with low income and in remote areas.

Reduced Transmission- Since rapid test kits produce results promptly, they help to identify persons with COVID-19 infection quickly. Hence, their swiftness can reduce the further transmission of the virus.

Scalability- FDA-approved rapid tests are easy to use and can be performed by medical professionals or even by individuals themselves. Ergo, a large quantity of population can benefit from it which increases the number of tests that can be done in a given period of time.


What is FDA Approved Rapid Test Kits?

FDA-approved rapid test kits are diagnostic tools issued by the FDA under EUA(Emergency Use Authorization) to identify the presence of COVID-19 pathogens in an individual nasal or throat swab. 

Is rapid test FDA-approved?

At-home OTC COVID-19 rapid tests are FDA approved for self-testing domestically, which means you can collect your own and your children’s samples, perform the test, and find out the outcome without having to send the samples to a laboratory.

Is the BINAXNOW test FDA approved?

The BINAXNOW COVID-19 antigen self-test kits are FDA-approved to use under Emergency Use Authorization only for testing the SARS-COV-2 virus.

Is Flowflex COVID-19 antigen home test approved?

Flowflex COVID-19 antigen home test is approved by the U.S. Food and Drug Administration (FDA) under an Emergency Use Authorization to use in domestic situations only for detecting proteins from SARS-CoV-2, not for any other viruses or pathogens.