COVID-19 Frequently Asked Questions | FDA

COVID-19 Frequently Asked Questions | FDA

The FDA is working to address the coronavirus disease (COVID-19) outbreak and keep you and your family informed on the latest developments. Here are answers to some frequently asked questions from consumers about testing:

Q: Is there a test for COVID-19?

A: Yes. The FDA has authorized two different types of tests (diagnostic and antibody tests) for use during the COVID-19 emergency.

Though there are currently no FDA-approved or cleared tests for COVID-19, the FDA has issued over 200 Emergency Use Authorizations (EUAs) for such tests. These EUAs allow the emergency use of tests during the COVID-19 emergency when the FDA determines certain criteria are met. These criteria include that the test may be effective at diagnosing or detecting antibodies to COVID-19 and that the known and potential benefits outweigh the known and potential risks.

• Read more about COVID-19 tests
• Learn more about EUAs in this video
• Find a community-based testing site

Q. How are people tested for COVID-19?

A. In general, for diagnostic tests, samples are collected from a person’s nose and/or throat using swabs or other collection devices by a health care provider in a health care setting. A health care professional swabbing the back of the nasal cavity through the nostril is the preferred way to collect a sample to test for COVID-19. Alternatively, a health care professional may swab the back of your throat or the inside of the front of the nose. Certain tests may also allow collection of alternative sample types. Additionally, the FDA has authorized some tests for use with home sample collection kits that are prescribed by a doctor and allow the patient to collect the sample at home and send it directly to the lab for analysis.

Learn more about the different types of tests and the steps involved in the FDA’s Consumer Update on Coronavirus Testing Basics and this video.

Q: Are there any tests that I can purchase to test myself at home for COVID-19?

A: No. At this time, the FDA has not authorized any COVID-19 test to be completely used and processed at home. However, the FDA has issued Emergency Use Authorizations (EUAs) for certain COVID-19 molecular diagnostic tests to be used with samples collected by a person using a home collection kit that is sent to a laboratory for processing and test reporting. In general, a health care provider determines whether a person can use a home collection kit as explained in each test’s EUA.

The FDA sees the public health value in expanding the availability of COVID-19 testing through safe and accurate tests that may include home collection options, and we are actively working with test developers to expand the use of such options.

Q: What is the difference between the types of tests available for SARS-CoV-2?

A: There are two different types of tests – diagnostic tests and antibody tests.

1. A diagnostic test can show if you have an active coronavirus infection and should take steps to quarantine or isolate yourself from others. Currently there are two types of diagnostic tests – molecular (RT-PCR) tests that detect the virus’s genetic material, and antigen tests that detect specific proteins on the surface of the virus. Samples are typically collected with a nasal or throat swab, or saliva collected by spitting into a tube.
2. An antibody test looks for antibodies that are made by the immune system in response to a threat, such as a specific virus. Antibodies can help fight infections. Antibodies can take several days or weeks to develop after you have an infection and may stay in your blood for several weeks after recovery. Because of this, antibody tests should not be used to diagnose an active coronavirus infection. At this time, researchers do not know if the presence of antibodies means that you are immune to the coronavirus in the future. While there is a lot of uncertainty with this new virus, it is also possible that, over time, broad use of antibody tests and clinical follow-up will provide the medical community with more information on whether or not, and how long, a person who has recovered from the virus is at a lower risk of infection if they are exposed to the virus again. Samples are typically blood from a finger stick or blood draw.

Learn more about antibody tests and about the different types of tests and the steps involved in the FDA’s Consumer Update on Coronavirus Testing Basics.