| 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 |
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COVID-19 Home Tests
COVID-19 Home Tests
