Skip to Content

Nonprescription At-Home COVID-19 Test Receives Emergency Approval

MONDAY, March 8, 2021 -- The U.S. Food and Drug Administration granted emergency use authorization (EUA) last week to two at-home tests to detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), including the first home test that does not require a prescription.

On Friday, the agency announced the EUA of the Cue COVID-19 Test for Home and Over The Counter (OTC) Use, a molecular nucleic acid amplification test intended to detect genetic material from SARS-CoV-2 in anterior nasal swab specimens. This test is authorized for nonprescription home use in adults who self-swab and children 2 years and older who are swabbed by an adult. It can be used in individuals with or without symptoms.

The test kit includes a nasal swab, test cartridge, test cartridge reader, and mobile app. The cartridge reader runs the test cartridge and communicates the results to the mobile app in about 20 minutes. Data have shown the Cue COVID-19 Test for Home and OTC Use correctly identified 96 percent of positive samples from symptomatic individuals and 100 percent of positive samples from asymptomatic individuals. Cue Health says it expects to produce more than 100,000 tests per day by this summer.

Also last week, the FDA issued an EUA for the Quidel QuickVue At-Home COVID-19 Test, an antigen test for prescription home use with self-collected anterior nasal swabs in people ages 14 years and older and for children 8 years and older whose swabs are collected by an adult. This test is authorized for individuals whose health care providers suspect COVID-19 within six days of symptom onset.

The FDA has now authorized more than 330 tests and collection kits for detecting SARS-CoV-2. "The FDA will continue to expand Americans' access to testing to help us in the fight against this pandemic, which has claimed over half a million lives in the United States," Acting FDA Commissioner Janet Woodcock, M.D., said in an agency news release.

More Information - Cue COVID-19 Test

More Information - Quidel QuickVue At-Home COVID-19 Test

© 2021 HealthDay. All rights reserved.

Read this next

COVID-19 Infection May Up Mortality in Surgical Patients

TUESDAY, April 13, 2021 -- COVID-19 infection is an independent risk factor for surgical mortality, according to a research letter published online April 12 in JAMA Network...

WHO Urges Halt to Sale of Live Wild Animals at Food Markets

TUESDAY, April 13, 2021 -- Countries should suspend the sale of live wild animals at food markets because they are a leading source of emerging infectious diseases such as...

FDA, CDC Call for Pause in J&J COVID-19 Vaccine After Six People Develop Clots

TUESDAY, April 13, 2021 -- After six people who received the Johnson & Johnson one-dose COVID-19 vaccine developed a type of rare and severe blood clot, the U.S. Food and Drug...

More News Resources

Subscribe to our Newsletter

Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.