FUJIFILM COVID-19 Ag Test

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

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