| Intended purpose |
SARS-CoV-2 antigen detection |
| Number of tests |
96 tests |
| Technology |
Qualitative ELISA assay |
| Equipment |
Microplate reader for absorbance measurement at 450 and at 620–700 nm |
| Clinical material |
Nasopharyngeal and oropharyngeal swabs |
| Analytical specificity |
The potentially interfering substances do not interfere with the assay result* |
| Limits of detection |
5 pg/ml for PBS as transport medium; 25 pg/ml for UTM® (COPAN Diagnostics Inc) as transport medium |
| Diagnostic specificity |
99% (95% CI 95 % – 100%)* |
| Diagnostic sensitivity |
98 % (95% CI 89% – 100%)* |
| Storage conditions |
2–8 ºC |
| Transportation conditions |
2–8 ºC* |
| Shelf life |
12 months |
| * See the user manual for the details |
|
