What Is the FDA Classification of a COVID-19 Antibody Test?

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What is classified as an antibody test?

How do antibody tests get Federal Drug Administration classifications?

Rebecca Rose Woodland, litigator and legal analyst, joined TheStreet to talk about how antibody tests are classified and the liability healthcare providers have when warning people as they administer antibody tests.  

Watch the full video above for more.

Video Transcript:

Katherine Ross: At this point in time, there's a lot of unknowns and a lot of uncertainty. And some of that uncertainty actually comes from the antibody test that we've seen in the headlines. So joining me today to break down what the classification of an antibody test is, is Rebecca Rose Woodland, litigator and legal analyst. So Rebecca, let's start there. What is the FDA's classification of an antibody test?

Rebecca Rose Woodland: So the FDA over the last few weeks and over even the last few days, has come to some understanding of how we can move forward in antibody tests. So the antibody tests are being defined in an emergency manner of tests that can detect antibodies from COVID. Beyond that, the very scientific aspect of this continues to evolve as we're evolving. So what the FDA has done is allow some emergency uses of antibody tests and we've seen that Abbott Laboratories has been granted over the last two days an emergency use of a new COVID antibody test. It is for scientific purposes though. The distinction is that having the antibodies doesn't assign the individual immunity as far as we know yet, so it is for scientific and epidemiologists purposes, to be able to identify those who may have had the disease in the past.

Katherine Ross: So taking into account what you just said, what liability do or healthcare providers have to warn people who are tested with an antibody test?

Rebecca Rose Woodland: So that's really, a really great question because we have some issues right now. And the fact that we're in a pandemic, the government has issued in March, an order that dated back to February 4th of 2020, it's called the PREP Act. They enacted this in 2005 and have reauthorized the use of it. And what it is is The Public Readiness and Emergency Preparedness Act. It absolves liability for people, companies, users who are making developing, testing, manufacturing, administrating use of products that the federal government has approved for a pandemic. What it doesn't do is absolve of complete liability, and it is not a complete absolution for individual healthcare facilities. There's a lot of legal red tape on what is immune and what isn't. So my best discussion on this as an attorney is to tell my clients, no, there is no room for error here so go over and above. If you give a test result, make sure you say that the test result may show you have had COVID doesn't mean you're immune. If you give a test result that says you are positive or negative for the disease give the amount of discrepancy in the test. Some tests are 60% accurate, some are 80% accurate. Until we have a complete understanding of this very broad virus and how it's affecting everyone, liability is very flexible and movable. So even though there's an immunity granted to some from the federal government, it is not a complete and overall immunity that we can apply across the board. So I think people have to be very, very careful and corporations very careful in how they move forward with their antibody tests and their COVID tests.

Katherine Ross: Rebecca, thank you for joining us today and for more on the Coronavirus pandemic, head on over to thestreet.com.

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