A Non-Prescription, At-Home COVID-19 Test

FDA approves first molecular non-prescription, at-home COVID-19 test

(RxWiki News) The US Food and Drug Administration (FDA) has approved a new COVID-19 test. This is the first test approved for at-home use without a prescription.

The FDA approved the Cue COVID-19 Test for Home and Over The Counter (OTC) Use through an emergency use authorization (EUA). This test is a molecular nucleic acid amplification test (NAAT) that detects genetic material from the COVID-19 virus in the nostrils.

“The authorization of this new diagnostic test underscores FDA’s goal to continue supporting innovation in testing and providing flexibility to test developers with the aim of increasing the availability of accurate and reliable tests for all Americans,” said Acting FDA Commissioner Dr. Janet Woodcock in a press release.

The FDA's EUA approved this test for use in adults and children older than 2. The test uses a nasal swab to gather a sample. A cartridge that comes with the test then tests the sample and sends the results to a mobile app the user downloads on their smartphone.

Test results can come in as quickly as 20 minutes, the FDA said.

In the future, the app that goes with the test will allow users to report a positive test result to the corresponding health authorities.

The FDA approved this test based on results from trials of the test. The new COVID-19 test correctly identified 96 percent of positive samples from people who were showing COVID-19 symptoms and 100 percent of samples from people who were positive without symptoms.

The maker of this test, Cue Health, said it plans to produce over 100,000 of the new tests per day by this summer. These tests will be available over the counter. You will not have to have COVID-19 symptoms to purchase or use the test.

If you suspect that you have COVID-19, follow guidance from health officials to self-isolate and call your health care provider. Ask your health care provider before using any over-the-counter or prescription COVID-19 product.

Review Date: 
March 18, 2021