Table 5 Antigen lateral flow assays with EUA from U.S. FDA
From: Monoclonal antibodies for COVID-19 therapy and SARS-CoV-2 detection
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 | NAVICAâ„¢ 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 Veritorâ„¢ At-Home COVID-19 Test | Becton Dickinson & Company | 187 | NP | Scanwell Health App | Sens: 84.6% Spec: 99.8% | ns |
CelltrionDiaTrustâ„¢ 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 |