The content on this page is intended to healthcare professionals and equivalents.
- Uses Silver Amplification technology for high detection sensitivity
- Time to results: Approximately 15 minutes
- Compatible with both visual and reader detection
- Nasopharyngeal swab
The immunochromatographic assay was designed based on silver halide photography to amplify the size of gold colloidal particles approximately a 100-fold, leading to the improvement of detection sensitivity. This offers a greater ability to detect even in small amounts of antigens.
- * Refer to the Instruction for Use for official procedures.
Clinical performance was established using retrospectively collected 225 samples (nasopharyngeal swabs).
Sensitivity: 90.9% (110/121, 95% CI: 84.3-95.4%)
Specificity: 100.0% (104/104, 95% CI: 96.5-100.0%)
| RT-PCR | ||||
|---|---|---|---|---|
| Positive | Negative | Total | ||
| FUJIFILM COVID-19 Ag Test | Positive | 110 | 0 | 110 |
| Negative | 11 | 104 | 115 | |
| Total | 121 | 104 | 225 | |
Sensitivity according to the RT-PCR Ct value
| RT-PCR Ct value | |||||
|---|---|---|---|---|---|
| < 26 | < 28 | < 30 | < 35 | ||
| FUJIFILM COVID-19 Ag Test |
Positive | 100 | 107 | 110 | 110 |
| Negative | 0 | 3 | 6 | 11 | |
| Total | 100 | 110 | 116 | 121 | |
| Sensitivity | 100.0% | 97.3% | 94.8% | 90.9% | |
| 95% CI | 96.4-100.0% | 92.2-99.4% | 89.1-98.1% | 84.3-95.4% | |
- Test Cartridge × 10 tests
- Extraction Reagent Solution R1 × 10 × 0.4mL
- Sterile Swab × 10 pieces
- Tube Rack (for Extraction Reagent Solution R1) × 1 piece
- Filter (for Extraction Reagent Solution R1) × 10 pieces
- Package Insert × 1 piece
- FUJIFILM SILVAMP Reader
left : FUJIFILM COVID-19 Ag Test
right : FUJIFILM SILVAMP Reader