Table 5.
Antigen lateral flow assays with EUA from U.S. FDA
| Test name | Company | LoD (TCID50/ml) | Target | Device | SARS-CoV-2 accuracy information | Type of sample |
|---|---|---|---|---|---|---|
| BinaxNOW COVID-19 Ag Card Home Test | Abbott Diagnostics Scarborough, Inc | 140.6 | NP | NAVICA™ Mobile App |
Sens: 91.7% Spec: 100% |
ns |
| BinaxNOW COVID-19 Ag Card | Abbott Diagnostics Scarborough, Inc | 140.6 | NP | N/A |
Sens: 97.1% Spec: 98.5% |
ns |
| CareStart COVID-19 Antigen test | Access Bio, Inc | 800 | NP | N/A |
Sens: 88.4% Spec: 100% |
np |
| NIDS® COVID-19 Antigen Rapid Test Kit | ANP Technologies, Inc | 311 | NP | N/A |
Sens: 95.1% Spec: 97% |
ns |
| BD Veritor System for Rapid Detection of SARS-CoV-2 | Becton Dickinson & Company | 140.0 | NP | BD Veritor Plus Analyzer |
Sens: 84% Spec: 100% |
ns |
| BD Veritor™ At-Home COVID-19 Test | Becton Dickinson & Company | 187 | NP | Scanwell Health App |
Sens: 84.6% Spec: 99.8% |
ns |
| CelltrionDiaTrust™ COVID-19 Ag Rapid Test | Celltrion USA, Inc | 32 | NP, RBD | N/A |
Sens: 93.3% Spec: 99.0% |
np |
| Ellume COVID-19 Home Test | Ellume Limited | 6309 | NP | Ellume COVID-19 Home Test App |
Sens: 95% Spec: 97% |
ns |
| GenBody COVID-19 Ag | GenBody Inc | 111 | NP | N/A |
Sens: 91.1% Spec: 100% |
np |
| SCoV-2 Ag Detect Rapid Test | InBios International, Inc | 6300 | NP | N/A |
Sens: 86.7% Spec: 100% |
ns |
| iHealth COVID-19 Antigen Rapid Test | iHealth Labs, Inc | 20,000 | NP | N/A |
Sens: 94.3% Spec: 98.1% |
ns |
| Clip COVID Rapid Antigen Test | Luminostics, Inc | 88 | NP | Clip COVID Rapid Antigen Test |
Sens: 96.9% Spec: 100% |
ns |
| InteliSwab COVID-19 Rapid Test | OraSure Technologies, Inc | 250 | NP | N/A |
Sens: 84% Spec: 98% |
ns |
| InteliSwab COVID-19 Rapid Test Pro | OraSure Technologies, Inc | 250 | NP | N/A |
Sens: 84% Spec: 98% |
ns |
| Status COVID-19/Flu | Princeton BioMeditech Corp | 2700 | NP | N/A |
Sens: 93.9% Spec: 100% |
np |
| INDICAID COVID-19 Rapid Antigen Test | PHASE Scientific International, Ltd | 2800 | NP | N/A |
Sens: 84.4% Spec: 96.3% |
ns |
| QIAreach COVID-19 Rapid Antigen | QIAGEN GmbH | 50,000 | NP | QIAreach eHub |
NP: Sens: 80.7% Spec: 98.3% NS: Sens: 85% Spec: 99.1% |
np, ns |
| Sofia 2 SARS Antigen FIA | Quidel Corporation | 113 | NP | Sofia 2 |
Sens: 96.7% Spec: 100% |
np, ns |
| Sofia 2 Flu + SARS Antigen FIA | Quidel Corporation | 91.7 | NP | Sofia 2 |
Sens: 95.2% Spec: 100% |
np, ns |
| QuickVue SARS Antigen Test | Quidel Corporation | 7570 | NP | N/A |
Sens: 96.6% Spec: 99.3% |
ns |
| QuickVue At-Home COVID-19 Test | Quidel Corporation | 19,100 | NP | N/A |
Sens: 84.8% Spec: 99.1% |
ns |
| Sienna-Clarity COVID-19 Antigen Rapid Test Cassette | Salofa Oy | 1250 | NP | N/A |
Sens: 87.5% Spec: 98.9% |
np |
LoD limit of detection, NP nucleoprotein, np nasopharyngeal, ns nasal, Sens sensitivity (positive percent agreement), Spec specificity (negative percent agreement). The commercial kits granted with EUA are updated on the FDA and FIND websites. The assays are listed in alphabetical order of the company names