FDA Authorizes First Over-the-Counter, Non-Prescription COVID-19 Test

In a large step towards increasing access and making it easier to get COVID-19 testing, the FDA recently expanded its authorization of Pixel by LabCorp to become the first at-home collection test available over the counter (OTC) for people at least 18 years old. This same test was authorized back in April as the first at-home collection test. The new authorization now expands its reach into retail channels.

Here we’ll cover what you need to know about the test, and when it will be available.

What is it?

So what’s different? Same test, but with expanded availability. 

Instead of having to go through a provider to access the test kit by prescription, you can buy it over the counter from a store or online. In other words, you’ll be able to walk into a store, purchase a test kit, and collect your sample from the comfort of your home.

How does the over-the-counter COVID-19 test work?

The Pixel by LabCorp test kit is used to detect the presence of viral genetic material in a sample that is collected at home using a nasal swab. Unlike the deep nasopharyngeal swabs that are often associated with COVID-19 testing, these only go in as far as the inside edge of both nostrils.

Once the sample has been collected, the swab is placed inside a tube provided with the testing kit. Everything is packaged up and sent to the laboratory for processing. You should expect to have your results within 1 to 2 days of the laboratory receiving your sample.

What do my results mean?

If your test comes back positive, you’ll get a phone call from a healthcare provider. This means that you are likely infected with the virus.

If your test comes back negative, you’ll receive your results either by email or through a web portal. This means that the test did not detect the virus in your sample. But if you test too early or too late in the infection, it is possible to get a false negative result. This means that you actually are infected with the virus, but your results are negative. If you get a negative result but you are experiencing symptoms of COVID-19, you’ll want to contact your provider about next steps.

There is also a possibility that your test results come back invalid. This can sometimes happen if you did not get a good enough sample with your swab, or if you did not ship your sample back within 24 hours of collecting it. If this is the case, you’ll be contacted by phone to discuss next steps.

When will the test be available?

The Pixel by LabCorp test kit is currently available through their website here. For now, you’ll only be able to order a test if you have symptoms, exposure to the virus, or were instructed by your provider or health department to get tested.

As far as being able to purchase the test kit from a store or pharmacy, there is not an established date yet for when we can expect to see the kits available on the shelves. 

How much does it cost?

If you meet clinical guidelines, the test is available with no upfront cost when you get it online. If you have insurance, the company can bill your plan on your behalf. If you don’t have insurance, the company can use federal funds to cover the cost of the test.

You also have the option to pay out of pocket for the test, which costs $119.

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Written by:

Alyssa Billingsley, PharmD

Alyssa Billingsley, PharmD, is the director of pharmacy content for GoodRx. She has over a decade of experience as a pharmacist and has worked in clinical, academic, and administrative roles.

Edited by:

Dan Wagener, MA

Dan Wagener is an editor and writer with experience in healthcare, mental health, and prescription drug use and misuse. At GoodRx, he works on stories and reports on drug prices, prescription trends, mental health, telehealth, and consumer-focused topics such as copay cards.

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