Before we get too far into this one, it is time to share some good news. The Food and Drug Administration has finally approved an at-home COVID-19 test and it does not require a prescription. LabCorp’s Pixel COVID-19 Test Home Collection Kit has been approved for usage, as long as the test subject is at least 18 years of age or older.
Nasal swab samples are collected at home and shipped off to LabCorp for results. From there, the method of transmittal of the test’s result will be determined by the need for follow up action. If the test result is not valid or it is positive, the customer receives a phone call from a health care provider.
If the test is negative, the results are relayed through an online portal or an e-mail. Test kits are available online and in stores. The FDA’s press release lays it all out. “This home sample collection kit can be purchased online or in a store without a prescription. It is intended to enable users to access information about their COVID-19 infection status that could aid with determining if self-isolation (quarantine) is appropriate and to assist with health care decisions after discussion with a health care professional.
“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,” said Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health. “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, allowing anyone to collect their sample and send it to the lab for processing.”
That all seems straightforward enough, right? Meanwhile, this is actually not the first at-home test kit that the FDA has authorized. The Lucira COVID-19 All-In-One Test Kit was designed for usage by customers 14 and above provides rapid results and requires a prescription. “The Lucira COVID-19 All-In-One Test Kit test has been authorized for home use with self-collected nasal swab samples in individuals age 14 and older who are suspected of COVID-19 by their health care provider.
It is also authorized for use in point-of-care (POC) settings (e.g., doctor’s offices, hospitals, urgent care centers, and emergency rooms) for all ages but samples must be collected by a healthcare provider when the test is used at the POC to test individuals younger than 14 years old. The test is currently authorized for prescription use only,” reads the description on the FDA website.
Any and all at-home tests like these should be tracked and monitored, which should go without saying. As long as all of the proper protocol is being followed, things should be safe. Local, state, and federal requirements state that prescribing health care providers will have to report all of their test results to the relevant public health authorities. Some may wonder if allowing people to poke themselves with swabs is a great idea at the moment.
Let’s be honest, though. That horse is out of the bar now. The American people have decided that the virus is something they are willing to live with. If these tests give people the peace of mind that they need to travel over the holidays, so be it. A combination COVID-19/flu test is also slated to be issued and it received approval last month. These tests could play an instrumental role in helping Americans survive the winter months.
Winters tend to be brutal from a disease standpoint anyway. Now that COVID-19 is a part of our lives for the foreseeable future, it is easy why the FDA is working overtime to provide affordable testing. According to the Qwest Diagnostics site, the combination test can be had for just $130. There are certainly nits that can be picked here but we will simply take solace in the fact that we are moving in a positive direction.