Table 1.
Main properties of the three RADTs evaluated in this study.
| Quidel Sofia SARS Antigen FIA | SD Biosensor SARS-CoV-2 Rapid Antigen test | Abbott Panbio™ COVID-19 Ag Rapid TEST Device NP | |
|---|---|---|---|
| Intended use | Nasopharyngeal and nasal swabs | Nasopharyngeal swabs | Nasopharyngeal swabs |
| Target | Nucleocapsid protein | Nucleocapsid protein | Nucleocapsid protein |
| Interpretation of results | Sofia or Sofia2 instrument | Visual | Visual |
| Procedural control/visible control line | Yes/No | Yes/Yes | Yes/Yes |
| External controls | Yes | Available, but not included in the kit | Yes |
| LoD, as reported by the manufacturer | 1.13 × 102 TCID50/mL | 3.12 × 102.2 TCID50/mL | 2.5 × 101.8 TCID50/mL |
| Sensitivity, as reported by the manufacturer | 96.67% | 96.52 % | 93.33 % |
| Specificity, as reported by the manufacturer | 100 % | 99.68 % | 99.45 % |
| Incubation time | 15 min | 15−30 minutes | 15−20 minutes |
| Sample volume | 120 μL | 3 drops | 5 drops |
| Sample volume when using a frozen VTM sample μL | 250 | 350 | 150 |
| Sample dilution when using a frozen saline sample in this study, approximately | 1:6 | 1:4 | 1:10 |
| Regulatory certification | CE-IVD, FDA EUA | CE-IVD | CE-IVD |
| Lots used in this evaluation | 143,489 | QCO3020105 | 41ADF024A |