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FDA Insight: All About COVID-19 Testing

Dr. Anand Shah, FDA's Deputy Commissioner for Medical and Scientific Affairs, welcomes Toby Lowe, the Associate Director of the Office of In Vitro Diagnostics and Radiological Health, to discuss the basics of diagnostic tests for COVID-19.

FDA Insight: Episode 2 – Transcript

>> Anand Shah: Hello, and welcome to our new podcast, FDA Insight. I'm Dr. Anand Shah, the deputy commissioner for Medical and Scientific Affairs here at FDA. And I'm pleased you're joining me for our second episode. Our goal is to use this podcast to educate listeners about what we do and why we do it. We have many stakeholders involved and interested in our work but none more important than the American people. Here, we're going to talk about the products that we regulate, the issues that we face, and the processes that we follow in plain language. In particular, we're hoping to reach patients and consumers, as well as the healthcare community. We'll be discussing both COVID-19 and non-COVID-19 related topics on this podcast. But today we're going to continue with a COVID-19-related topic from last week's episode.

Today, I have with me Toby Lowe, associate director for our In Vitro Diagnostics Program at FDA. Toby, thanks for joining me today. Can you start out by telling us a little bit about what the FDA device center does?

>> Toby Lowe: Absolutely and thanks for having me today. CDRH, or the Center for Devices and Radiological Health, helps to ensure access to safe and effective medical devices, as well as safe radiation emitting products. We provide regulatory oversight for all medical devices, which is a broad range of products from toothbrushes, to thermometers, to pacemakers. We also provide consumers, patients, caregivers, and providers with information they need about the products that we oversee. The office that I'm in, the Office of In Vitro Diagnostics and Radiological Health, or OIR, is one of several device type specific offices in the center. We oversee all in vitro diagnostic devices, or IVDs, which include a lot of different products including the lab test that your doctor may order when you have a routine physical, tests to diagnose cancer, and some tests that you might use at home, like glucose test strips or a pregnancy test. And now, of course, we're doing a lot of work with COVID-19 tests.

>> Anand Shah: Thanks for that overview. Let's jump into what Americans want to know about tests for COVID-19. What are the different types of diagnostic tests that are available?

>> Toby Lowe: Diagnostic tests can tell you if you currently have an infection. We've authorized many diagnostic tests for COVID-19, including molecular tests and antigen tests. These work in different ways. So molecular tests work by looking for genetic material from the virus, and they are doing that by using a sample from a patient's nose, such as a nasal swab. This sample is then usually sent to a laboratory to be analyzed. And for some tests, the sample can be analyzed at the point-of-care, such as at the doctor's office. We've authorized the emergency use of many COVID-19 molecular tests. And in doing that, we've reviewed data showing that these tests are very accurate. Results are returned anywhere from minutes to several days, depending on the test.

And then antigen tests are another type of diagnostic test that we've authorized for use during COVID-19. These type of tests look if there are viral proteins in a sample taken from inside your nose with a swab. Antigen tests are often simpler and may provide results faster than many molecular tests and sometimes that'll be within minutes at a doctor's office. Antigen tests, however, can be less accurate, so they may need confirmation with an additional diagnostic test, but because they're simpler, they can be made more widely available.

>> Anand Shah: That's great. Thank you. I know a lot of people are very interested in at-home tests, as well. Can you tell us a bit about at-home testing? Are there any tests that can be performed at home?

>> Toby Lowe: Right now, there are not any FDA-authorized tests for COVID-19 that can be completely used and processed at home. However, there are some tests where a patient can collect a sample at home, using a special kit, and then they would send that sample into a lab for processing. In this case, the patient does not need to leave their home to get swabbed for a sample, and that's important because that reduces the exposure to other patients or healthcare providers. This will help lighten the load at doctor's offices and testing centers and means that less personal protective equipment, or PPE, needs to be used. Ultimately, at-home sample collection can help get more patients tested.

>> Anand Shah: Toby, are there any downsides to at-home sample collection as opposed to, say, going to a doctor's office or to a lab?

>> Toby Lowe: When we review at-home collection kits and tests for use with home-collected samples, we look at the ability of a normal person, so someone without healthcare background, to follow the directions in the collection kit, collect their own sample, and package, and ship it properly. We reviewed data that makes sure that that transport process, getting it from the person's home to the lab, will not affect the quality of the sample. That sample might be sitting in a hot mailbox or a cold truck, for example, and we want to make sure that that does not affect the results of their test. We also look at the performance of the test with the type of sample that can be tested -- I'm sorry, that can be collected at home. The tests we've authorized for use with home-collected samples meet the same standards for emergency use authorization as tests for use with samples collected by a healthcare provider.

>> Anand Shah: Now, what about the different sample types and collection methods for these diagnostic tests?

>> Toby Lowe: Many types of diagnostic tests and many of the tests that were first authorized for COVID-19 require swabbing deep inside of the nose. For those tests, the swab needs to go deep into the nose to get a reliable sample. For other tests, however, including those authorized for at-home sample collection, the swab doesn't need to go as deep into the nose, which makes it more comfortable for the patient, and makes it possible for a patient to safely take their own sample at home. We've also authorized a couple of tests that use a saliva sample. And we're open to working with test developers to authorize additional tests that use saliva.

>> Anand Shah: Got it. Now that we've talked about getting diagnosed, let's talk briefly about what happens after an infection, your body's antibody response.

>> Toby Lowe: Right. Antibodies are produced by your body when you're infected by a virus, and they help your immune system fight off that infection. An antibody test is sometimes called a serology test, and it detects antibodies to the virus using a blood sample. There are different types of blood samples that can be collected. A very reliable sample is from a blood draw from a vein in your arm, just like if you were getting your cholesterol checked at the doctor's office. Some tests also might be able to work with a fingerstick sample, which is simpler, and can be self-collected, but these may not be as accurate. Currently, there are no antibody tests for COVID-19 that are authorized for use with fingerstick samples, but we do continue to work with developers on this. And it's also important to note that antibody tests should not be used to diagnose a current COVID-19 infection. It takes time for your body to develop antibodies and not everyone who is infected develops antibodies. So a molecular or antigen test should be used to diagnose a current infection.

>> Anand Shah: Thanks for walking us through all of that. Now let's get to the question that's certainly on some folk's minds. How does one get a test? And what should people look for in choosing one?

>> Toby Lowe: Right now, all COVID-19 tests must be ordered by a healthcare provider. They require a prescription. So you should consult your doctor or healthcare provider if you think you need a test. They'll be best able to get you a reliable test near you. Now, those doctors and healthcare providers who are looking for tests for their patients, a good first step is to talk to the laboratory where you'd normally send patients for routine lab work to see if those labs are offering COVID-19 testing. And we also have information on the performance of all authorized tests available on our website.

>> Anand Shah: Yes, and we can include that in our show notes so that our listeners can easily find it. Well, that wraps it up for today. Thanks, Toby, for joining us to talk about the important work FDA and our device center is doing to help us combat COVID-19. And thanks to everyone for joining us on today's podcast. I hope you'll tune in to future episodes. We'll be answering topics from our response to COVID-19, as well as other topics unrelated to the pandemic like sunscreen, food, and nutrition. As always, we'll be providing you insight in plain language to help you understand the products that we regulate, the issues that we face, and the processes that we follow. If you want to hear more, please subscribe on your podcast app of choice, such as Apple Podcasts, Google Play, and others. Thanks for listening, and we'll be back soon.

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