How to Tell if Your COVID-19 Test Is Authorized by the FDA

But with the reopening (gradual or otherwise, depending on where you live) of businesses and activities, more and more COVID-19 tests are finally becoming available. In this Alert, we look at the types of tests that are available and provide a way that you can check on whether a particular test that you have taken or are intending to take has been authorized by the FDA.

First of all, a bit of background. The FDA has established an Emergency Use Authorization (EUA) process whereby it reviews certain information from developers of tests and determines whether those tests can be marketed and used in the United States. The EUA process is not a full approval from the FDA, but a limited authorization for the duration of the pandemic in order to meet the overwhelming demand for more and better testing.

There are three broad categories of tests that have been authorized:

1. “PCR” (which stands for “polymerase chain reaction”) or “Molecular” tests. These tests detect genetic material from the virus and will tell you if you have an active COVID-19 infection. In general, these are among the most accurate tests on the market, but running them and analyzing the results can take some considerable time because specimen samples often have to go to a specific laboratory for further processing.
2. “Serology” or “Antibody” tests. These tests detect antibodies to the coronavirus. Because the antibodies are part of the body’s immune response to exposure and not to the virus itself, these tests cannot be used to diagnose whether you have an active COVID infection, but they will tell you if you have had an infection in the past. This might be important if antibodies protect you from future infections, something science has not yet determined to be the case. Nor has science yet determined how long the antibodies remain in the body after the infection has cleared.
3. “Antigen” tests. These tests detect fragments of proteins found on or within the COVID-19 virus. The main advantage of an antigen test is that results can be provided in minutes. However, antigen tests may not detect all active infections as they do not work in the same way as a PCR/molecular test. Antigen tests are very specific for the virus but are not as sensitive as PCR tests. This means that positive results from antigen tests are highly accurate, but there is a higher chance of false negatives, so negative results do not rule out an infection. Thus negative results from an antigen test should be confirmed with a PCR test prior to making treatment decisions or to prevent the possible spread of the virus due to a false negative.

As of June 16, FDA has granted EUAs for 119 PCR/Molecular tests, 20 Antibody/Serology Tests, and 1 Antigen test.

You can check on whether a particular test has been authorized by the FDA by following these simple steps:

1. First, determine if your test is a PCR/Molecular or a Serology/Antibody or an Antigen test.

   1. If your test is a PCR/Molecular test, log onto these two FDA websites and see the Chart entitled “Individual EUAs for Molecular Diagnostic Tests for SARS-CoV-2” and and see Chart entitled “Appendix A:  Authorized Molecular-Based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2.”
   2. If your test is a Serology/Antibody test, log into this FDA website and see the Chart entitled “Individual EUAs for Serology Tests for SARS-CoV-2”
   3. If your test is an Antigen test (and there is only one that has been approved to date), log into this FDA website and see the Chart entitled “Individual EUAs for Serology Tests for SARS-CoV-2”

2. Type in the name of the manufacturer or developer of the test that you took (or are planning to take) in the “Search” box. If you don’t know the manufacturer/developer of your test, your healthcare professional should be able to provide you with that information and the name will also appear on the sheet of paper that you are given at the time of the test – the “Fact Sheet for Patients.”  
3. If your test has been authorized under an EUA, it will be listed after the Search is performed. You can obtain the actual EUA by clicking the link in the “Diagnostic (Letter of Authorization)” column. The table also provides the type of test – Molecular, Serology, or Antigen – in the “Technology” column, and links to where there is additional information in the “Authorization Documents” column. The EUA and the Additional Documents should give you information on the accuracy of the test.

That’s it. This simple procedure will let you know if a particular test has been authorized by the FDA under an EUA.

Now there are other tests that are being used under the authority of certain state governmental agencies where the state authorizes certain laboratories to conduct testing. FDA allows these states to offer tests under their own authority and does not require that they submit EUAs. The states that have notified the FDA that they are choosing to do this are the states of Connecticut, Maryland, Mississippi, Nevada, New Jersey, New York’s Department of Health Wadsworth Center, and the Washington State Department of Health.[1]

[1] Under an early FDA policy, certain manufactures of PCR/molecular tests were allowed to market their tests by simply notifying the Agency that they had validated their tests and were providing certain cautions on the labeling for the tests. Twenty-five manufacturers have notified the Agency that they are doing this, only seven of which have received EUAs to date.
For serology/antibody tests, under this same early FDA policy, laboratories and commercial manufacturers were allowed to market serology tests also by simply notifying the Agency that they had validated their tests and providing certain labeling cautions. Twenty-three laboratories have notified the FDA that they are marketing these serology tests, and only one has received an EUA. For commercial manufacturers, 195 have notified the Agency that they will be marketing such tests, and only 11 have received EUAs to date.