Germany

FUJIFILM COVID-19 Ag Test

Exclusive reagent for COVID-19 Ag(Target specimen: Nasopharyngeal swab)

The content on this page is intended to healthcare professionals and equivalents.

Product Features

  • Uses Silver Amplification technology for high detection sensitivity
  • Time to results: Approximately 15 minutes
  • Compatible with both visual and reader detection
  • Nasopharyngeal swab

Silver Amplification technology

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.

How to use

  • * Refer to the Instruction for Use for official procedures.

Performance results

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%

Kit contents

FUJIFILM COVID-19 Ag Test (10 tests)

  • 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

Additional instrument (Optional, not included)

  • FUJIFILM SILVAMP Reader

left : FUJIFILM COVID-19 Ag Test
right : FUJIFILM SILVAMP Reader