What Is The FDA Covid Test? | FDA Covid Testing And Accuracy

FDA Covid Test

There are different types of tests available to know the presence of coronavirus in the human body, that is, rapid test, PCR Covid test, FDA Covid Test, etc.

Covid-19 is one of the deadly diseases, that is constantly spreading across the world inflicting lots of deaths and infections. People are struggling very badly and combat every day with this illness. It can create a pandemic state of affairs throughout the world.

Covid-19 is caused by a virus and so, making an antidote to it is so difficult. And, also, many researchers suggest up and once more begin a new wave of Covid-19. Since it is a communicable disease(spreads from person to person by contact), that’s why it is spreading very rapidly and a larger population of human beings are infecting by it.

What Is FDA Covid Test?

FDA(Food And Drugs Administration) is a federal system in the US, that looks after the Department of Health and Human Services. The main work of the FDA is to manage the public health condition, by looking after medical services, human and veterinary drugs, biological products, etc. It also managesthe food supply, cosmetics, and others drugs, and various food departments.

Its approval is important as it not only ensure the safety of adults but also sees the effects of particular medicine or drugs on kids. There are FDA Approved Covid-19 Test which is now used for checking the presence of coronavirus. FDA Covid Test can be trusted as it ensures complete safety from the test.

FDA Approved Antibody Test

Antibody tests are the tests that detect the presence of antibodies that are developed in return for coronavirus infection. It is not used for the diagnosis of the active coronavirus. Antibodies remain in the person’s body even they have recovered from the infection.

FDA have approved more than 50 antibodies or serology test, that test the presence of antibody of coronavirus. A serology test can fail or give a false report when a person is infected with the virus in the early stages and has not developed antibodies. So, it can not be used to test the presence of active coronavirus.

FDA Approved Covid-19 Test

On 23 July of 2021, FDA has issued a notification regarding FDA Approved Covid-19 Test, which is summarized as follows:-

  • There is a total of 395 types of test and sample collection devices that have been approved by the FDA for Covid test under Emergency use Authorization (EUA).
  • In these 395 tests, 279 tests are molecular tests, 86 are antibody tests and 30 are regarded as antigen tests.
  • Also, it includes 52 molecular authorization and one antibody approved is there which can be tested at home.
  • It also includes three antigen prescription tests and one molecular prescription test, which can be done at home. Also, two molecular OTC (over-the-counter) and five antigen OTC tests are available which can be done at home itself.
  • FDA has approved a total of 8 molecular tests and eleven antigen tests for a serial screening program. It has also approved total of 596 revisions of EUAs.

FDA Approved Face Mask

FDA Approved Face Mask is easily available. The face masks approved by FDA protected a person from various air-borne diseases to a 95% extent. FDA has suggested using N95 respirators, which is the most suitable mask for Covid-19. It also approves surgical masks but it doesn’t give any protection from coronavirus.

The N95 masks are easily available in local chemists or medical shops. It is a one-time mask. It is broken or gets loose, then, replace it as soon as possible. You can throw Or dispose of it by covering it in polythene bags and then wash your hands nicely.

FDA Covid Test Accuracy

The first COVID-19 test approved by FDA is the Antigen test. It is also called the gold standards of the covid test. It is the most accurate test of all. It tests the presence of genetic material of microorganisms. When we talk about FDA Covid Test Accuracy, then, the antigen test is about 95% accurate.

It has a very rare chance of giving wrong reports. Also, when we talk about antibody tests, the accuracy rate is very high. There is very little chance that the reports are false.

Learn About  PCR Covid Test And Rapid covid Test Report, Accuracy, And Result.

FDA Covid Test Kits

The presence of Covid-19 can be detected through various tests. And, to conduct these types of tests, there are different types of testing kits available. Not all testing kits are accurate and can be used, so, FDA has approved various testing kits that can be used to give accurate and precise results.

Some FDA Covid Test Kits which are authorized are named below:-

  1. InBios Smart Detect SARS-CoV-2 rRT-PCR Kit: This kit is approved by FDA on April 7 under EUA. It is the type of RT-PCR test.
  2. Gnomegen COVID-19 RT-Digital PCR Detection Kit: This test was authorized on April 6 by FDA. It is the type of RT-digital PCR test.
  3. BD SARS-CoV-2 Reagents for the BD MAX™ System: This is the type of RT-PCR test and was approved by FDA on April 8, under EUAs.
  4. Cellex qSARS-CoV-2 IgG/IgM Rapid Test: It is the first antibody testing kit that is approved by FDA. It tells the presence of coronavirus in a blood sample collected from patients. NeuMoDx Molecular™ SARS-CoV-2 Assay – This was approved on March 30. It is the type of RT-PCR test, which gives results in less than 80-90 minutes. 
  5. Avellino CoV-2 Test: It is a real-time RT-PCR test, that is certified to oy high authorized labs. It was approved by FDA on March 25.
  6. Primerdesign Ltd. COVID-19 genesig Assay: It is a test kit approved by FDA on March 20. It is a type of RT-PCR test.

There are more than 300 test kits that are approved by FDA for the Covid test. These tests are conducted in labs, clinics, drive-through techniques, hospitals, etc. FDA Covid Test can also be done at home.

FDA Covid Test At Home

 FDA Covid Test can also be done at home. FDA has approved many tests, that can be easily done at home. The antigen molecular OTC (over the counter) and antigen OTC are available and approved by FDA, which can be conducted in the home itself.

Since, Covid-19 is spreading very rapidly, so it is advised to stay at home. And, many tests are available that can easily be done at home. FDA Covid Test three antigen prescription tests and one molecular prescription test that can be done at home.

FDA Covid Test can be trusted as it is authorized by FDA and these tests are also highly accurate. FDA has issued many guidelines that one should follow to stay safe from Covid-19.


What is FDA doing to control Covid-19?

FDA is a federal system that basically governs the medical services, public health, biological products, drugs, medicines, food items, etc so that public welfare and health are taken care of. It has approved various FDA Covid Test vaccines, test kits, masks, issued guidelines and instructions so that spread of covid-19 is controlled.

What is the role of the FDA in vaccines approval?

FDA is also working on the approval of vaccines. It regulates vaccines and tests whether it is safe to use them or not. The first vaccine of Covid-19 was approved by FDA on 11 December 2020, that was Pfizer-BioNTech and then, it approved Moderna on 18 December 2020. Later on, many vaccines were approved and are now currently been used across the world.

What does it mean when FDA approves any drugs, medicine, food, or vaccines, etc?

When FDA approves any kind of product, it means that the particular products can be used for the intended use. Its complete details like its use, advantage, risks, and all other information are stated. It approves any product only when it is under public welfare and harmless to people’s health.