COVID-19 Home Tests
COVID-19 Home Tests
The following are authorized at-home over the counter (OTC) COVID-19 diagnostic tests under Emergency Use Authorization (EUA) by the FDA. All tests on this list are performed via nasal swab for self-testing.
Device Company Age Time to Result Clinical performance versus RT-PCR Notes
Antigen Tests
CareStart COVID-19 Antigen Home Test Access Bio ≥2yrs 10mins Positive agreement 87%
Negative agreement 98%

• Use if symptoms began in the last 7 days, or if no symptoms, perform test 2 times over 3 days.

QuickVue At-Home OTC COVID-19 Test Quidel ≥2yrs 10mins Positive agreement 83.5%
Negative agreement 99.2%

• Use if symptoms began in the last 6 days, or if no symptoms, perform test 2 times over 3 days.

BinaxNOW COVID-19 Ag Card Home Test Abbott Diagnostics ≥2yrs 15mins Positive agreement 84%
Negative agreement 98.3%

• Use if symptoms began in the last 7 days, or if no symptoms, perform test 2 times over 3 days.

• Telehealth proctor supervision required.

• Smartphone or computer required.

BinaxNOW COVID-19 Antigen Self Test Abbott Diagnostics ≥2yrs 15mins Positive agreement 84.6%
Negative agreement 98.5%

• Use if symptoms began in the last 7 days, or if no symptoms, perform test 2 times over 3 days.

Flowflex COVID-19 Antigen Home Test ACON Laboratories ≥2yrs 15mins Positive agreement 93%
Negative agreement 100%

• Use if symptoms began in the last 7 days, or if no symptoms, perform test 2 times over 3 days.

• Alternative name: On/Go One COVID-19 Antigen Home Test.

BD Veritor At-Home COVID-19 Test Becton, Dickinson and Company ≥2yrs 15mins Positive agreement 84.6%
Negative agreement 99.8%

• Use if symptoms began in the last 7 days, or if no symptoms, perform test 2 times over 3 days.

• Smartphone required.

Celltrion DiaTrust COVID-19 Ag Home Test Celltrion USA ≥14yrs 15mins Positive agreement 86.7%
Negative agreement 99.8%

• Use if symptoms began in the last 7 days, or if no symptoms, perform test 2 times over 3 days.

• Mid-turbinate nasal swab.

Ellume COVID-19 Home Test Ellume Limited ≥2yrs 15mins Positive agreement 95%
Negative agreement 97%

• Use for individuals with or without symptoms.

• Mid-turbinate nasal swab.

• Smartphone required.

iHealth COVID-19 Antigen Rapid Test iHealth Labs ≥2yrs 15mins Positive agreement 94.3%
Negative agreement 98.1%

• Use if symptoms began in the last 7 days, or if no symptoms, perform test 2 times over 3 days.

MaximBio ClearDetect COVID-19 Antigen Home Test Maxim Biomedical ≥2yrs 15mins Positive agreement 86.9%
Negative agreement 98.9%

• Use if symptoms began in the last 5 days, or if no symptoms, perform test 2 times over 3 days.

CLINITEST Rapid COVID-19 Antigen Self-Test Siemens Healthineer ≥2yrs 15mins Positive agreement 86.5%
Negative agreement 99.3%

• Use if symptoms began in the last 7 days, or if no symptoms, perform test 2 times over 3 days.

SCoV-2 Ag Detect Rapid Self-Test InBios International ≥2yrs 20mins Positive agreement 86.7%
Negative agreement 100%

• Use if symptoms began in the last 5 days, or if no symptoms, perform test 2 times over 3 days.

COVID-19 At-Home Test SD Biosensor ≥2yrs 20mins Positive agreement 95.3%
Negative agreement 100%

• Use if symptoms began in the last 6 days, or if no symptoms, perform test 2 times over 3 days.

InteliSwab COVID-19 Rapid Test OraSure Technologies ≥2yrs 30mins Positive agreement 85%
Negative agreement 98%

• Use if symptoms began in the last 7 days, or if no symptoms, perform test 2 times over 3 days.

MOLECULAR TESTS
Cue COVID-19 Test for Home and Over The Counter (OTC) Use Cue Health ≥2yrs 20mins Positive agreement 97.4%
Negative agreement 99.1%

• Use for individuals with or without symptoms.

• Smartphone and Cue Cartridge Reader required.

Lucira CHECK-IT COVID-19 Test Kit Lucira Health ≥2yrs 30mins Positive agreement 92%
Negative agreement 98%

• Use for individuals with or without symptoms.

Detect Covid-19 Test Detect ≥2yrs 60mins Positive agreement 90.9%
Negative agreement 97.5%

• Use if COVID-19 suspected, or if no symptoms, perform test 2 times over 3 days.

• Smartphone and Detect Hub required.

REFERENCES

US Food and Drug Administration. At-Home OTC COVID-19 Diagnostic Tests. https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/home-otc-covid-19-diagnostic-tests. Accessed on March 1, 2022.

Created 3/2022