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

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

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

  • 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.
    • Smartphone required.
    • 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.
    • Smartphone required.
    • 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


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  • Cue COVID-19 Test for Home and Over The Counter (OTC) Use (Cue Health, Inc)
    • Molecular test.
    • 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)
    • Molecular test.
    • 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)
    • Molecular test.
    • 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.

Source: Medical Bag https://www.medicalbag.com/home/news/fda-provides-list-of-at-home-otc-covid-19-diagnostic-tests/

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