Case and point!! Read
Will patients spend this much for a home test or $30 for a finger price test?? Read below: FDA stops home testing in there tracks!!!
Can I Test for Coronavirus At Home? The State of At-Home COVID-19 Tests
Diane Li
Diane Li is a research analyst who examines drug pricing and healthcare trends for GoodRx.
Posted on May 26, 2020
Key Takeaways:
As of May 19, there are five companies selling authorized at-home tests to detect coronavirus: Pixel by LabCorp ($119), Everlywell ($109), Vault ($150), Vitagene ($149) and hims & hers ($150).
Pixel by LabCorp will not require upfront payment for its coronavirus tests, and will either seek reimbursement from insurance or from the government for the uninsured. Everlywell, Vault, Vitagene and hims & hers require upfront payment for their tests.
All companies are prioritizing tests for those who may be exposed or are currently experiencing symptoms. The test availability will vary by state.
Scanwell Health is still validating its at-home blood test to detect COVID-19 antibodies and still intends to seek FDA authorization in the future.
Every new day in the developing pandemic confirms what the public already knows: not nearly enough Americans are being tested for the coronavirus disease (COVID-19). This is largely due to a shortage of diagnostic testing capabilities. But tracing infected individuals is an important step in preventing new infections.
One of the many ideas that cropped up to meet diagnostic demands is at-home COVID-19 tests. Currently, five companies are selling at-home tests authorized by the FDA. But can the results be trusted? And what other tests may be on the way?
Are at-home COVID-19 tests authorized by the FDA?
The FDA has authorized at-home coronavirus tests sold by Pixel by LabCorp, Everlywell, Vault, Vitagene, and hims & hers under an Emergency Use Authorization (EUA). Receiving an EUA does not mean that the product is officially FDA-approved. It’s an authorization that allows unapproved products to be used during the public health crisis. While Pixel by LabCorp and Everlywell obtained an EUA for its own at-home COVID-19 tests directly, Vault, Vitagene and hims & hers are all selling an FDA EUA-authorized test developed by RUCDR Infinite Biologics, in partnership with Spectrum Solutions and Accurate Diagnostic Labs.
The availability — and accessibility — of at-home coronavirus tests was not always the reality. Earlier in March 2020, companies started selling at-home COVID-19 tests but were stopped in their tracks by the FDA. The false start was due to confusion over the interpretation of FDA guidelines. The situation began to unfold when the FDA gave EUAs to labs and manufacturers. Some start-ups realized this meant they could use this opportunity to send people a kit to collect their own samples that would then be sent to authorized labs for testing.
Once these kits began to circulate online, the FDA issued a statement on March 20, 2020 explaining that they have yet to authorize any self-administered tests at home, but that they saw the public health value in the tests and would work with at-home coronavirus test developers. Just a month later on April 21, the FDA authorized the first at-home test.
How do coronavirus home test kits work?
Authorized at-home COVID-19 tests are provided by the following companies: Pixel by LabCorp ($119), Everlywell ($109), Vault ($150), Vitagene ($149) and hims & hers ($150).
You can still find information on the websites of the three companies that attempted, or are still attempting, to offer at-home tests:
Nurx
Carbon Health
Scanwell Health
All the services generally require you to complete some type of questionnaire or online consultation to assess your COVID-19 risk first. Then you will be sent a test along with instructions on how to collect a sample. This is where companies start to differ.
Pixel by LabCorp, Everlywell, Vault, Vitagene, hims & hers Nurx, and Carbon Health require customers to send their samples to a select lab with a prepaid shipping label. A provider from the company will follow-up with results and next steps through an app, email, or by phone. Scanwell Health, however, requires the customer to take a blood sample. The customer cannot interpret the test but will have to take a picture of the blood sample testing stick via the app. The picture will be sent to a provider for interpretation and follow-up. For more information about each company, see the chart below.
There are two main types of tests for coronavirus (COVID-19): molecular and serological tests. Pixel by LabCorp, Everlywell, Vault, Vitagene, hims & hers, Nurx and Carbon Health all sell molecular tests. Molecular tests will detect COVID-19 genetic material in patient samples. The Scanwell Health offers a serological test and is aimed at detecting antibodies in the blood. More information about the different coronavirus tests available can be found here.
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How accurate are coronavirus home tests?
The foundation of any diagnostic test is its accuracy. In fact, the FDA provides recommendations for the test validation in its EUA policy, emphasizing that “false results can have broad public health impact.” The FDA stated that they worked with LabCorp to see that data from at-home sample collection is as safe and as accurate as collection in a doctor’s office, hospital or other testing site.
Everlywell used data from other studies that demonstrated stability of testing samples during shipping. Vault claims that their test is very sensitive for the presence of SARS-CoV-2, with 98% of tests providing either a positive or a negative result, and only 2% of tests providing an inconclusive result. Vitagene states on their website that their coronavirus test has a sensitivity of 99.99% and a specificity of 100%
There is little information available on the accuracy of the non-authorized at-home tests. To understand the complexity of defining test accuracy, you can read more here.
Test accuracy is one of the many standards the FDA is reviewing as part of the EUA application. A list of all diagnostic tests beyond at-home tests authorized under the FDA EUA is available here.
Are coronavirus at-home tests available yet?
Yes, five at-home COVID-19 tests are currently available for purchase. The companies require all customers to fill out an intake survey that is meant to prioritize the test for those who may have been exposed, are experiencing symptoms, or are part of a high-risk population. The Everlywell test is not available in the states of New York, New Jersey, Maryland, or Rhode Island. The Pixel by LabCorp test is not available in New York, the Vault test is not available in Alaska, and the hims & hers test availability varies by state. The Vitagene test is available in all states
How do the other non-FDA approved at-home coronavirus tests fare? Scanwell Health is currently validating their test internally and with lab partners around the country. They are currently pursuing FDA EUA approval for their product.
What other ways can I assess if I have COVID-19?
Self-assessment guidelines provided by the CDC that can be found here. In addition, HeyDoctor by GoodRx will connect you with a healthcare provider via phone or video to review your symptoms and tell you if you should get tested. The best part? The service costs $0.
If you feel that you need to be tested or are told to do so, the CDC recommends that you call your local or state health department or medical provider first. While testing supplies are increasing, it may still be difficult to find a place to get tested.
