The FDA Just Authorized the First At-Home COVID-19 Test

The Food and Drug Administration (FDA) just gave emergency-use authorization to an at-home COVID-19 test for the first time in an effort to make coronavirus testing a little bit easier and more convenient. The test, which is performed using a nasal swab, can give users their results in 30 minutes or less.

The Lucira COVID-19 All-in-One Test Kit is designed to detect the presence of SARS-CoV-2, the virus that causes COVID-19. Users swab the inside of their nostrils (not as far into the nasal cavity as the deeper nasopharyngeal swabs), then swirl it in a vial that is then placed in the test kit, the FDA press release explains. Within 30 minutes, the test kit’s green light display will tell the user if their results are positive or negative.

Lucira’s test, like some other COVID-19 tests, looks for the coronavirus’s genetic material in a patient’s sample. The gold standard for COVID-19 tests uses a lab method called the polymerase chain reaction (PCR) to multiply the genetic material present in a sample enough times that it becomes detectable. The Lucira test does this with a similar method that can be done quickly at home but is generally thought to be less accurate than the standard PCR tests.

If you get a positive result from the Lucira test, it’s very likely that you have COVID-19. And if you test negative, it’s likely that any symptoms you might be feeling are not due to the coronavirus, the package insert reads. But in either case, patients should get in touch with their health care provider for further guidance. That’s partly because both false-positive results and false-negative results are possible with this test, as with pretty much all tests. When compared to a high-sensitivity FDA-authorized COVID-19 test, the Lucira test correctly identified 94% of positive cases and 98% of negative cases, according to the package insert.

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This new test is authorized specifically for home use by people aged 14 and older, provided their doctor suspects they have COVID-19, which means that it’s available only via prescription. It’s also authorized to be used in certain health care settings (such as urgent care centers, doctors’ offices, and hospitals).

There are other commercially available tests on the market that you can take at home, but you still need to send your sample to a lab in order to actually process the sample and give you results. This new test is unique in that it can be fully performed—and give you results—at home. Additionally, many over-the-counter home COVID-19 tests available now are quite expensive (typically $100 or more). But the Lucira test will cost around $50, according to the company’s press release. It’s not clear whether or not health insurance coverage factors into that estimate.

Because the Lucira test requires a prescription, it’s not as easy to get your hands on as the other over-the-counter tests out there, which you can order online typically by just filling out a simple questionnaire. But having this at-home COVID-19 test option could make testing much more convenient for those who think they may have COVID-19, especially in the age of virtual doctors visits.

Related:

https://www.self.com/story/lucira-at-home-covid-19-test-fda-authorization, GO TO SAUBIO DIGITAL FOR MORE ANSWERS AND INFORMATION ON ANY TOPIC

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