FDA Approves New Stay At Home COVID Tests (REPORT)

(ConservativePeak.com)- People will soon be able to get quick COVID-19 test results from the comfort of their own home.

On Tuesday, the Food and Drug Administration approved a COVID-19 test that is over the counter and can be taken at home using a nasal swab. The best part is that the test has near-instant results.

As Stephen Hahn, the commissioner of the FDA, said in a statement:

“By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes. Today’s authorization is a major milestone in diagnostic testing for COVID-19.”

This isn’t the first stay-at-home COVID-19 test the FDA has approved. In fact, the agency has approved more than 25 of them already. However, all of the other tests required samples to be sent to a lab, where they would be analyzed. Results were then relayed to people taking the test at a later time.

The diagnostics company that makes this at-home test that has near-instant results is called Ellume. They are based out of Australia.

Jeff Shuren, who serves as the director of the FDA’s Center for Devices and Radiological Health, said there are some drawbacks to this new test. However, it is still a major development and represents significant progress at diagnosing coronavirus.

In the release, he said:

“This test, like other antigen tests, is less sensitive and less specific than typical molecular tests run in a lab. However, the fact that it can be used completely at home and return results quickly means that it can play an important role in response to the pandemic.”

Antigens are proteins that are contained within the coronavirus. It’s not considered as accurate a way to detect COVID-19 as the molecular tests that can be run in a lab. But at the same time, it’s a good tool for people to use to identify potential infection and then stop the spread before it happens.

The FDA included a reminder with its announcement, saying “all tests can experience false negative and false positive results.”

People who test positive using this at-home test should “self-isolate and seek additional care from their health care provider.” For those who test negative but are having some COVID-19 symptoms, the FDA says they “should follow up with their health care provider as negative results do not preclude an individual from SARS-CoV-2 infection.”

Last month, emergency use was granted by FDA regulators for a similar at-home coronavirus test that produced quick results. The big difference, though, is that a prescription is required to obtain that test.

Initial supplies of this new over-the-counter test will likely be limited. The company said it is expecting to produce roughly 3 million tests in January before they ramp up production of the test in the first half of the new year. That would coincide with more widespread distribution of the COVID-19 vaccines hitting the market.