An inventory of licensed at-home OTC COVID-19 diagnostic checks is now obtainable on the Meals and Drug Administration (FDA) web site. These checks, which have all been issued Emergency Use Authorization by the Company, embrace:

10-Minute Assessments

  • CareStart COVID-19 Antigen Dwelling Take a look at (Entry Bio, Inc)
    • Use if signs started within the final 7 days, or if no signs, carry out take a look at 2 occasions over 3 days.
    • Nasal swab; could also be used on people 2 years and older.
    • Medical efficiency vs RT-PCR: Constructive settlement 87%; unfavourable settlement 98%.
  • QuickVue At-Dwelling OTC COVID-19 Take a look at (Quidel Company)
    • Use if signs started within the final 6 days, or if no signs, carry out take a look at 2 occasions over 3 days.
    • Nasal swab; could also be used on people 2 years and older.
    • Medical efficiency vs RT-PCR: Constructive settlement 83.5%; unfavourable settlement 99.2%.

15-Minute Assessments


Proceed Studying

  • BinaxNOW COVID-19 Ag Card Dwelling Take a look at (Abbott Diagnostics)
    • Use if signs started within the final 7 days, or if no signs, carry out take a look at 2 occasions over 3 days.
    • Nasal swab; could also be used on people 2 years and older.
    • Telehealth proctor supervision required.
    • Medical efficiency vs RT-PCR: Constructive settlement 84%; unfavourable settlement 98.3%.
  • BinaxNOW COVID-19 Antigen Self Take a look at (Abbott Diagnostics)
    • Use if signs started within the final 7 days, or if no signs, carry out take a look at 2 occasions over 3 days.
    • Nasal swab; could also be used on people 2 years and older.
    • Medical efficiency vs RT-PCR: Constructive settlement 84.6%; unfavourable settlement 98.5%.
  • Flowflex COVID-19 Antigen Dwelling Take a look at (ACON Laboratories)
    • Use if signs started within the final 7 days, or if no signs, carry out take a look at 2 occasions over 3 days.
    • Nasal swab; could also be used on people 2 years and older.
    • Different identify: On/Go One COVID-19 Antigen Dwelling Take a look at
    • Medical efficiency vs RT-PCR: Constructive settlement 93%; unfavourable settlement 100%.
  • BD Veritor At-Dwelling COVID-19 Take a look at (Becton, Dickinson and Firm)
    • Use if signs started within the final 7 days, or if no signs, carry out take a look at 2 occasions over 3 days.
    • Nasal swab; could also be used on people 2 years and older.
    • Medical efficiency vs RT-PCR: Constructive settlement 84.6%; unfavourable settlement 99.8%.
  • Celltrion DiaTrust COVID-19 Ag Dwelling Take a look at (Celltrion USA)
    • Use if signs started within the final 7 days, or if no signs, carry out take a look at 2 occasions over 3 days.
    • Mid-turbinate nasal swab; could also be used on people 14 years and older.
    • Medical efficiency vs RT-PCR: Constructive settlement 86.7%; unfavourable settlement 99.8%.
  • Ellume COVID-19 Dwelling Take a look at (Ellume Restricted)
    • People with or with out signs could use the take a look at.
    • Mid-turbinate nasal swab; could also be used on people 2 years and older.
    • Medical efficiency vs RT-PCR: Constructive settlement 95%; unfavourable settlement 97%.
  • iHealth COVID-19 Antigen Speedy Take a look at (iHealth Labs, Inc)
    • Use if signs started within the final 7 days, or if no signs, carry out take a look at 2 occasions over 3 days.
    • Nasal swab; could also be used on people 2 years and older.
    • Medical efficiency vs RT-PCR: Constructive settlement 94.3%; unfavourable settlement 98.1%.
  • MaximBio ClearDetect COVID-19 Antigen Dwelling Take a look at (Maxim Biomedical, Inc)
    • Use if signs started within the final 5 days, or if no signs, carry out take a look at 2 occasions over 3 days.
    • Nasal swab; could also be used on people 2 years and older.
    • Medical efficiency vs RT-PCR: Constructive settlement 86.9%; unfavourable settlement 98.9%.
  • CLINITEST Speedy COVID-19 Antigen Self-Take a look at (Siemens Healthineer)
    • Use if signs started within the final 7 days, or if no signs, carry out take a look at 2 occasions over 3 days.
    • Nasal swab; could also be used on people 2 years and older.
    • Medical efficiency vs RT-PCR: Constructive settlement 86.5%; unfavourable settlement 99.3%.

20-Minute Assessments

  • Cue COVID-19 Take a look at for Dwelling and Over The Counter (OTC) Use (Cue Well being, Inc)
    • People with or with out signs could use the take a look at.
    • Nasal swab; could also be used on people 2 years and older.
    • Smartphone and Cue Cartridge Reader required.
    • Medical efficiency vs RT-PCR: Constructive settlement 97.4%; unfavourable settlement 99.1%.
  • SCoV-2 Ag Detect Speedy Self-Take a look at (InBios Worldwide Inc)
    • Use if signs started within the final 5 days, or if no signs, carry out take a look at 2 occasions over 3 days.
    • Nasal swab; could also be used on people 2 years and older.
    • Medical efficiency vs RT-PCR: Constructive settlement 86.7%; unfavourable settlement 100%.
  • COVID-19 At-Dwelling Take a look at (SD Biosensor Inc)
    • Use if signs started within the final 6 days, or if no signs, carry out take a look at 2 occasions over 3 days.
    • Nasal swab; could also be used on people 2 years and older.
    • Medical efficiency vs RT-PCR: Constructive settlement 95.3%; unfavourable settlement 100%.

30-Minute Assessments

  • Lucira CHECK-IT COVID-19 Take a look at Equipment (Lucira Well being, Inc)
    • People with or with out signs could use the take a look at.
    • Nasal swab; could also be used on people 2 years and older.
    • Medical efficiency vs RT-PCR: Constructive settlement 92%; unfavourable settlement 98%.
  • InteliSwab COVID-19 Speedy Take a look at (OraSure Applied sciences, Inc)
    • Use if signs started within the final 7 days, or if no signs, carry out take a look at 2 occasions over 3 days.
    • Nasal swab; could also be used on people 2 years and older.
    • Medical efficiency vs RT-PCR: Constructive settlement 85%; unfavourable settlement 98%.

60-Minute Assessments

  • Detect Covid-19 Take a look at (Detect, Inc)
    • Use if COVID-19 suspected, or if no signs, carry out take a look at 2 occasions over 3 days.
    • Nasal swab; could also be used on people 2 years and older.
    • Smartphone and Detect Hub required.
    • Medical efficiency vs RT-PCR: Constructive settlement 90.9%; unfavourable settlement 97.5%.

Reference

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

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