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Coronavirus home test kits: These are the tests available now
The FDA has authorized several at-home coronavirus test kits, and you can now get them easily.
Mercey LivingstonCNET Contributor
Mercey Livingston is a health and wellness writer and certified Integrative Nutrition Health Coach. She's written about fitness and wellness for Well+Good, Women's Health, Business Insider, and Prevention.com among others. When not writing, she enjoys reading and trying out workout classes all over New York City.
During the first few months of the coronavirus pandemic, COVID-19 tests were in extremely short supply. You needed a doctor's orders to get tested, and to get those orders, you had to meet specific criteria, such as having a fever and showing other COVID-19 symptoms.
The US isn't struggling as much now with a shortage of coronavirus test kits and related supplies, thanks partly to the advent of at-home testing. These tests -- of which there are now eight authorized for use -- eliminate the need for someone who is feeling sick to go to a testing site or clinic, which in turn means that fewer people are exposed to the virus.
More than half a year into the pandemic, testing remains a crucial element of slowing the spread, because it identifies people who are carrying the virus, both those who are ill and those who aren't exhibiting any symptoms. Once people are aware that they are infected, they can take the proper measures to avoid others to prevent exposure.
Medical testing companies started developing
home test kits back in March, but the Food and Drug Administration was initially slow to authorize them, warning consumers of potentially fraudulent tests. As the pandemic wore on, the FDA began issuing emergency use authorizations, or EUAs, to help increase the total number of available tests. As of October, just about anyone can order an at-home coronavirus test with just a few clicks.
Here's what to know about at-home test kits, the FDA's stance and how to get tested if you have symptoms of COVID-19 or think you've been exposed.
Types of at-home coronavirus tests available
There are currently two types of tests available for home use: swab tests and saliva tests.
Much like taking a DNA test, saliva tests have you spit into a tube, seal it and send to a lab. These tests are't invasive and can easily be done at home, which helps protect health care professionals from being exposed to the coronavirus at testing sites, and reduces the demand for personal protective equipment.
On April 13, the FDA granted Rutgers University's RUCDR Infinite Biologics biorepository emergency authorization for a new method it developed to test saliva samples for the coronavirus. It wasn't until May 8 that the FDA authorized Rutgers Clinical Genomics Laboratory to actually start testing samples of saliva collected at home for the coronavirus, using collection kits from Spectrum Solutions. This was the first at-home diagnostic test using saliva samples, and it originally could only be obtained with a prescription from a doctor. Now, all you have to do is take an assessment that asks about your symptoms.
Following that authorization from the FDA, two companies, Vault Health and 1Health.io (the parent company of Vitagene), announced plans to sell the saliva tests for at-home use under supervision from a doctor through telemedicine. Both tests are now available without telemedical approval.
Saliva tests are much less invasive, less uncomfortable and pose less risk for health care providers -- so why did it take so long to approve them? The FDA needed to make sure the samples could provide the same level of accuracy as nasal swabs. When it comes to concerns over how the saliva tests perform compared to nasal swabs, the research is promising.
Yale Public Health researchers published preliminary research in April that showed saliva tests were just as accurate -- and sometimes even more accurate -- than nasal swab tests. Since then, morestudies have repeated and confirmed those findings.
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Swab tests require you to swab the inside of your nose or cheek to collect a sample that can be tested for the coronavirus. While many swab tests at testing sites collect a sample from deep in your nasal passage, at-home versions are less invasive.
The FDA authorized the first at-home test kit, Pixel by LabCorp, on April 21. The FDA worked with LabCorp to develop the test, and said it's as accurate as a sample taken by a doctor. The test is performed with a special swab enclosed in the kit that the patient uses to take a sample from the nasal passage, and then you mail your sample back to LabCorp.
Initially, this test required a doctor's orders to purchase, but it has since become available to everyone who takes a short assessment.
This was the first at-home coronavirus test granted an EUA from the FDA, and it's currently the only one that doesn't require an up-front cost. You can choose to pay for this test with a credit card, but otherwise, LabCorp will bill your insurance for the cost. If you don't have insurance and can't pay for the test, LabCorp uses allocated federal funds to cover the cost of the test.
LetsGetChecked offers an easy-to-use at-home coronavirus test kit, and you can use your flexible spending account or health savings account to cover the cost. I tried the LetsGetChecked at-home COVID-19 test -- here are my results.
Everlywell was one of the first brands to release its at-home coronavirus test kit. It quickly pivoted to a health professionals-only test and then rereleased its kit to the public after the FDA granted Everlywell an EUA. You'll have to pay for this test up-front, but you can pay with an FSA or HSA, and submit your receipt to your health insurance.
Vault originally released its at-home test with the caveat that you needed supervision from a telehealth doctor, but now, you can purchase the test after taking the online symptom screening. You will have to fill out an additional medical questionnaire after purchasing the test in order for the company to ship the kit.
Vault requires up-front payment for their at-home coronavirus test, but they accept FSAs and HSAs as forms of payment. You can also get an itemized receipt for insurance reimbursement.
Fulgent Genetics, the manufacturer of the Picture coronavirus test, requires you to take a screening and then sign up for an account, so a physician can authorize your test. This test requires up-front payment, but you may be able to submit your receipt for insurance reimbursement.
The at-home tests from Hims and Hers, two branches of the same telehealth company, require you to undergo a virtual medical consultation before purchasing the test, so a health care provider can help you determine if the test is right for you. Hims and Hers take some forms of insurance, which might cover the cost of your test.
Phosphorus is very transparent about the cost breakdown of its $150 at-home COVID-19 test. It also offers several ways to pay for your test. In addition to submitting an itemized receipt to your insurance for reimbursement, Phosphorous offers flexible financing options for people who think they need to get tested, but can't afford the test.
You could definitely consider all of the above at-home tests to be rapid -- getting your results back within days is pretty fast -- but something even quicker could be available to consumers soon.
Axios reported on Sept. 16 that two companies, Gauss and Cellex, are teaming up to manufacture the first rapid-results at-home coronavirus test for the public. This test would give you results in minutes, and there'd be no need to send your sample back to a lab.
The FDA has not approved or authorized this test, but it could happen if Gauss and Cellex can prove that their product is accurate and would help the bigger coronavirus fight.
What about antibody tests?
Antibody tests are an entirely different class of medical tests. An antibody test checks to see if you've had the novel coronavirus in the past, rather than checking for current infection. When you get sick with an infectious virus, your immune system produces antibodies to fight off the infection.
No one really knows what a positive COVID-19 antibody test means yet (for example, we don't know if it means you are immune to SARS-CoV-2), but gathering antibody data now can help scientists who study viral infections like COVID-19.
In June, the FDA sent warning letters to three companies claiming to manufacture antibody tests for COVID-19, saying that there were no FDA-authorized antibody tests available at that time.
As of October, no companies currently offer an authorized at-home antibody test for the novel coronavirus. Three home health companies, Imaware, Scanwell and Phosphorus, have antibody tests coming soon.
The Imaware test has been authorized for use under an FDA EUA, according to the website. Scanwell is working with another company, Lemonaid Health to develop and distribute its test, which the brands hope to submit for FDA authorization. Finally, Phosphorus has notified the FDA of its at-home antibody test and data and is waiting on FDA authorization.
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For many people, the only way to obtain a test is with a doctor's consent. That includes people who think they have been exposed but have no symptoms. You can try to contact a testing center in your area for a test, but the availability and eligibility depends on where you live.
The best action to take if you or someone you know is feeling sick is first to call your doctor so they can determine if you have symptoms of COVID-19. If your doctor decides you need to be tested, they will order a test and you'll be able to go to a drive-through testing center to receive it. A doctor can also order an at-home test for you, which will be shipped to you. In that case, you will collect the sample and be responsible for sending it back to the lab.
It's important to avoid going to a doctor's office, urgent care or ER if you have symptoms that match the coronavirus, because you can expose health care workers and those who are most at risk of getting fatally ill.
The exception to this is if you have any emergency warning signs for COVID-19, which do require immediate medical attention. These can include difficulty breathing or shortness of breath, persistent pain or pressure in the chest, new confusion or inability to arouse and bluish lips or face. If you are able to call the hospital to tell them you are coming, try to do that so they can prepare appropriately.
The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified health provider regarding any questions you may have about a medical condition or health objectives.