FUJIFILM COVID-19 Ag Test
Manufactured by FUJIFILM Corporation, Japan - https://www.fujifilm.com/
Device identification number
2428
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cartridge, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
FUJIFILM COVID-19 Ag Test is using Fujifilm’s proprietary silver amplification immunochromatographic method for signal amplification to increase the sensitivity and giving results in less than 15minutes. Yamaoka et al., Highly specific monoclonal antibodies and epitope identification against SARS-CoV-2 nucleocapsid protein for antigen detection tests, Cell Reports Medicine (2021), https://doi.org/10.1016/j.xcrm.2021.100311
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
11 minutes
Subclass
Other ()
LOD
110 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 % - Specificity 100% (104/104)
False negatives
9.1 % (- Sensitivity 90.9% Ct-value <35, n=121)
Precision
Evaluated
Accuracy
100 % ( (Antigen))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
90.9 % ( (Antigen))
Clinical Specificity
100 % ( (Antigen))
Type of antigen
Nucleoprotein
The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements