COVID-19

FDA Provides List of At-Home OTC COVID-19 Diagnostic Tests

Home » Specialties » Womens Health

A list of authorized at-home OTC COVID-19 diagnostic tests is now available on the Food and Drug Administration (FDA) website. These tests, which have all been issued Emergency Use Authorization by the Agency, include:

10-Minute Tests

  • CareStart COVID-19 Antigen Home Test (Access Bio, Inc)
    • Use if symptoms began in the last 7 days, or if no symptoms, perform test 2 times over 3 days.
    • Nasal swab; may be used on individuals 2 years and older.
    • Clinical performance vs RT-PCR: Positive agreement 87%; negative agreement 98%.
  • QuickVue At-Home OTC COVID-19 Test (Quidel Corporation)
    • Use if symptoms began in the last 6 days, or if no symptoms, perform test 2 times over 3 days.
    • Nasal swab; may be used on individuals 2 years and older.
    • Clinical performance vs RT-PCR: Positive agreement 83.5%; negative agreement 99.2%.

15-Minute Tests

Continue Reading

  • BinaxNOW COVID-19 Ag Card Home Test (Abbott Diagnostics)
    • Use if symptoms began in the last 7 days, or if no symptoms, perform test 2 times over 3 days.
    • Nasal swab; may be used on individuals 2 years and older.
    • Telehealth proctor supervision required.
    • Clinical performance vs RT-PCR: Positive agreement 84%; negative agreement 98.3%.
  • BinaxNOW COVID-19 Antigen Self Test (Abbott Diagnostics)
    • Use if symptoms began in the last 7 days, or if no symptoms, perform test 2 times over 3 days.
    • Nasal swab; may be used on individuals 2 years and older.
    • Clinical performance vs RT-PCR: Positive agreement 84.6%; negative agreement 98.5%.
  • Flowflex COVID-19 Antigen Home Test (ACON Laboratories)
    • Use if symptoms began in the last 7 days, or if no symptoms, perform test 2 times over 3 days.
    • Nasal swab; may be used on individuals 2 years and older.
    • Alternative name: On/Go One COVID-19 Antigen Home Test
    • Clinical performance vs RT-PCR: Positive agreement 93%; negative agreement 100%.
  • BD Veritor At-Home COVID-19 Test (Becton, Dickinson and Company)
    • Use if symptoms began in the last 7 days, or if no symptoms, perform test 2 times over 3 days.
    • Nasal swab; may be used on individuals 2 years and older.
    • Clinical performance vs RT-PCR: Positive agreement 84.6%; negative agreement 99.8%.
  • Celltrion DiaTrust COVID-19 Ag Home Test (Celltrion USA)
    • Use if symptoms began in the last 7 days, or if no symptoms, perform test 2 times over 3 days.
    • Mid-turbinate nasal swab; may be used on individuals 14 years and older.
    • Clinical performance vs RT-PCR: Positive agreement 86.7%; negative agreement 99.8%.
  • Ellume COVID-19 Home Test (Ellume Limited)
    • Individuals with or without symptoms may use the test.
    • Mid-turbinate nasal swab; may be used on individuals 2 years and older.
    • Clinical performance vs RT-PCR: Positive agreement 95%; negative agreement 97%.
  • iHealth COVID-19 Antigen Rapid Test (iHealth Labs, Inc)
    • Use if symptoms began in the last 7 days, or if no symptoms, perform test 2 times over 3 days.
    • Nasal swab; may be used on individuals 2 years and older.
    • Clinical performance vs RT-PCR: Positive agreement 94.3%; negative agreement 98.1%.
  • MaximBio ClearDetect COVID-19 Antigen Home Test (Maxim Biomedical, Inc)
    • Use if symptoms began in the last 5 days, or if no symptoms, perform test 2 times over 3 days.
    • Nasal swab; may be used on individuals 2 years and older.
    • Clinical performance vs RT-PCR: Positive agreement 86.9%; negative agreement 98.9%.
  • CLINITEST Rapid COVID-19 Antigen Self-Test (Siemens Healthineer)
    • Use if symptoms began in the last 7 days, or if no symptoms, perform test 2 times over 3 days.
    • Nasal swab; may be used on individuals 2 years and older.
    • Clinical performance vs RT-PCR: Positive agreement 86.5%; negative agreement 99.3%.

20-Minute Tests

  • Cue COVID-19 Test for Home and Over The Counter (OTC) Use (Cue Health, Inc)
    • Individuals with or without symptoms may use the test.
    • Nasal swab; may be used on individuals 2 years and older.
    • Smartphone and Cue Cartridge Reader required.
    • Clinical performance vs RT-PCR: Positive agreement 97.4%; negative agreement 99.1%.
  • SCoV-2 Ag Detect Rapid Self-Test (InBios International Inc)
    • Use if symptoms began in the last 5 days, or if no symptoms, perform test 2 times over 3 days.
    • Nasal swab; may be used on individuals 2 years and older.
    • Clinical performance vs RT-PCR: Positive agreement 86.7%; negative agreement 100%.
  • COVID-19 At-Home Test (SD Biosensor Inc)
    • Use if symptoms began in the last 6 days, or if no symptoms, perform test 2 times over 3 days.
    • Nasal swab; may be used on individuals 2 years and older.
    • Clinical performance vs RT-PCR: Positive agreement 95.3%; negative agreement 100%.

30-Minute Tests

  • Lucira CHECK-IT COVID-19 Test Kit (Lucira Health, Inc)
    • Individuals with or without symptoms may use the test.
    • Nasal swab; may be used on individuals 2 years and older.
    • Clinical performance vs RT-PCR: Positive agreement 92%; negative agreement 98%.
  • InteliSwab COVID-19 Rapid Test (OraSure Technologies, Inc)
    • Use if symptoms began in the last 7 days, or if no symptoms, perform test 2 times over 3 days.
    • Nasal swab; may be used on individuals 2 years and older.
    • Clinical performance vs RT-PCR: Positive agreement 85%; negative agreement 98%.

60-Minute Tests

  • Detect Covid-19 Test (Detect, Inc)
    • Use if COVID-19 suspected, or if no symptoms, perform test 2 times over 3 days.
    • Nasal swab; may be used on individuals 2 years and older.
    • Smartphone and Detect Hub required.
    • Clinical performance vs RT-PCR: Positive agreement 90.9%; negative agreement 97.5%.

Reference

US Food and Drug Administration. At-Home OTC COVID-19 Diagnostic Tests. Accessed February 23, 2022. https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/home-otc-covid-19-diagnostic-tests.

This article originally appeared on MPR

Topics:

COVID19
Diagnostic Agents

Want to read more?

Please login or register first to view this content.

Login
Register

Open


Next post in News

Close



Close more info about FDA Provides List of At-Home OTC COVID-19 Diagnostic Tests

Loading…



Close more info about FDA Provides List of At-Home OTC COVID-19 Diagnostic Tests

Loading…



Close more info about FDA Provides List of At-Home OTC COVID-19 Diagnostic Tests

Loading…



Close more info about FDA Provides List of At-Home OTC COVID-19 Diagnostic Tests

Loading…

Log in to continue reading this article.

Don’t miss out on today’s top content on The Medical Bag. Register for free and gain unlimited access to the latest in medical news, and lifestyle and business advice, with personalized daily picks for you. There’s something for every health care professional on The Medical Bag.

{{login-button}} {{register-button}}

Want to read more?

Please login or register first to view this content.

Login
Register

emanalazab22 3421 posts 0 comments
You might also like More from author

Comments are closed.