On December 9, the Food and Drug Administration (FDA) granted emergency use authorization for the first at-home coronavirus test available for use without a prescription. However, LabCorp, which produces the Pixel COVID-19 Test Home Collection Kit, is currently reserving these tests for people 18 and over who are symptomatic and/or who have received instructions to get tested from a health care provider, public health department, or contact tracer. Still, this is yet another milestone in the ongoing saga of COVID-19.
“This is the first kit for consumers to self-collect a nasal sample for COVID-19 in their home that does not require a prescription,” Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health, said in a statement. “While many home collection kits can be prescribed with a simple online questionnaire, this newly authorized direct-to-consumer collection kit removes that step from the process.”
This at-home coronavirus test is available through LabCorp’s website, and the FDA approval may eventually allow LabCorp to sell it through “retail channels” as well. In order to access one of these kits, you have to answer a series of questions about your COVID-19 risk, exposure, and current symptoms since the company is currently reserving the tests’ use for specific situations. The kits include nasal swab self-collection equipment to take a sample, which you would then send back to LabCorp for evaluation. The lab uses a polymerase chain reaction or PCR test to look for evidence of SARS-CoV-2, according to The Washington Post. This is considered the most effective way of detecting the virus.
Results take one or two days after the lab receives your sample, according to the company’s website, though you’d also need to factor in the time to receive the kit and send it back, which would add on additional time.
If you test positive, you should receive a phone call from a health care provider, while anyone who tests negative should get that result via email or through the company’s online portal, according to a statement by LabCorp.
The test costs $119, but worth noting: Payment actually isn’t required upfront. Private health insurance plans should generally cover the cost of the test, and federal legislation instituted in March 2020 says that anyone who is uninsured should get the cost of the test reimbursed.
In November, a similar test called the Lucira COVID-19 All-In-One Test Kit also received an emergency use authorization from the FDA, but it still requires a prescription, as SELF previously reported.
While this news is exciting, it’s essential to remember that both false positive and false negatives are possible with this test and also with other coronavirus tests as well. At-home tests can offer useful information, but experts recommend against taking the results as gospel. This is for many reasons, including that it’s possible to swab yourself incorrectly, which could influence the results of your test. This kind of at-home testing kit isn’t a substitute for a visit to a doctor or health care clinic, which the company’s statement emphasizes. And even if you get a negative test result from an actual health care provider, it’s not a free pass to ignore safety recommendations, especially with the way cases are spiking right now. Ultimately, though, with serious infrastructural issues continuing to make testing a mess in the U.S., an additional avenue to some form of testing doesn’t hurt.