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 |