Who makes ‘At home test’ products?
There are 36 testing products approved by the FDA, out of 36 there are 7 products which are approved for At home testing. Reading the jargon filled literature leaflet that is inside each test is confusing at best, so we have tried to make things simple by creating a table below. Hope you find it educational so you can make better decisions about which test you choose.
| Company | Brand | type of test | Feature | Specifications |
|---|---|---|---|---|
| ACON Labratories, Inc | FlowFlex Covid-19 Antigen Home Test | Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing | ||
| Test Format | Cassette | |||
| Specimen Format | Nasal Swab | |||
| Detects | nucleocapsid protein antigen from SARS-CoV-2 | |||
| Sample Volume | 4 to 5 drops of the prepared specimen | |||
| Clinical Sensitivity(PPA)* | 97.1% (83.8%-99.9%) 95% Confidence Intervals | |||
| Clinical Specificity(NPA)* | 99.6% (97.7%-99.9%) 95% Confidence Intervals | |||
| LOD | 1.6*102 TCID50/mL | |||
| Test Time | 15 minutes | |||
| Shelf Life | 24 Months | |||
| Store Temperature | 2 – 30 °C (36 - 86°F) | |||
| Becton, Dickinson and Company | BD Veritor At-Home COVID-19 Test | Lateral Flow, Digital Read, Over the Counter (OTC) Home Testing, Serial Screening | Test Format | Cassette |
| Specimen Format | Nasal Swab | |||
| Detects | nucleocapsid protein antigen from SARS-CoV-2 | |||
| Sample Volume | 3 drops | |||
| Clinical Sensitivity(PPA) | 84%(95% CI, 67%-93%) | |||
| Clinical Specificity(NPA) | 100%(95% CI, 98%-100%) | |||
| LOD | 1.4 x 102 TCID50/mL | |||
| Test Time | 15 mins | |||
| Shelf Life | ||||
| Store Temperature | 2-30°C (35-86°F) | |||
| Access Bio, Inc. | CareStart COVID-19 Antigen Home Test | Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening | Test Format | Cassette |
| Specimen Format | Nasal Swab | |||
| Detects | nucleocapsid protein antigen from SARS-CoV-2 | |||
| Sample Volume | 3 drops | |||
| Clinical Sensitivity(PPA) | 87.18% (95% CI: 73.29%-94.40%) | |||
| Clinical Specificity(NPA) | 100.00% (95% CI: 93.24%-100.00%) | |||
| LOD | 8 x 102 TCID50 /ml | |||
| Test Time | 10 mins | |||
| Shelf Life | 12 months | |||
| Store Temperature | 1-30°C (34-86°F) | |||
| Abbott Diagnostics Scarborough, Inc. | BinaxNOW COVID-19 Antigen Self Test | Lateral Flow, Visual Read, Over the Counter (OTC) Home Testing, Serial Screening | Test Format | Cassette |
| Specimen Format | Nasal Swab | |||
| Detects | nucleocapsid protein antigen from SARS-CoV-2 | |||
| Sample Volume | 6 drops | |||
| Clinical Sensitivity(PPA) | 84.6% (95% CI: 76.8% - 90.6%) | |||
| Clinical Specificity(NPA) | 98.5% (95% CI: 96.6% - 99.5%) | |||
| LOD | 140.6 TCID50/mL | |||
| Test Time | 15 mins | |||
| Shelf Life | 12 months | |||
| Store Temperature | 2 - 30°C (36 - 86°F) | |||
| OraSure Technologies, Inc. | InteliSwab COVID-19 Rapid Test | Lateral Flow, Visual Read, Prescription Home Testing | Test Format | Proprietary integrated collection swab |
| Specimen Format | Nasal Swab | |||
| Detects | nucleocapsid protein antigen from SARS-CoV-2 | |||
| Sample Volume | N/A | |||
| Clinical Sensitivity(PPA) | 84% (95% CI: 71%, 92% | |||
| Clinical Specificity(NPA) | 98% (95% CI: 93%, 99%) | |||
| LOD | 2.5 x 102 TCID50/mL | |||
| Test Time | 30-40 mins | |||
| Shelf Life | 9 months | |||
| Store Temperature | 2-30°C (36-86°F) | |||
| Quidel Corporation | QuickVue At-Home OTC COVID-19 Test | Lateral Flow, Visual Read, Prescription Home Testing | Test Format | DipStick - Test Strips |
| Specimen Format | Nasal Swab | |||
| Detects | nucleocapsid protein antigen from SARS-CoV-2 | |||
| Sample Volume | N/A | |||
| Clinical Sensitivity(PPA) | 83.5%(95% Cl: 74.9% to 89.6%) | |||
| Clinical Specificity(NPA) | 99.2%(95% Cl: 97.2% to 99.8%) | |||
| LOD | 1.91x104 TCID50/mL | |||
| Test Time | 10 mins | |||
| Shelf Life | 24 months | |||
| Store Temperature | 15°C to 35°C (59°F to 86°F) | |||
| Ellume Limited | Ellume Covid-19 Home Test | Lateral Flow, Fluorescence, Instrument Read, Over the Counter (OTC) Home Testing, Screening | Test Format | Analyzer with Bluetooth connectivity |
| Specimen Format | Nasal Swab | |||
| Detects | nucleocapsid protein antigen from SARS-CoV-2 | |||
| Sample Volume | 5 drops | |||
| Clinical Sensitivity(PPA) | 95% (95% CI 82% - 99%) | |||
| Clinical Specificity(NPA) | 97% (95% CI 93% - 99%) | |||
| LOD | 103.80TCID50/mL | |||
| Test Time | 15 mins | |||
| Shelf Life | ||||
| Store Temperature | 2-30°C (36-86°F) |
*Sensitivity refers to a test’s ability to designate an individual with disease as positive. Specificity of a test is its ability to designate an individual who does not have a disease as negative.
LOD(LoD). Why does Limit of Detection(LoD) matter?
Edit: Added Ellume’s at home test to the list.