Covid-19 Antigen CARD Kit
Manufactured by Fosun Diagnostics (Shanghai) Co. Ltd., China - https://www.fosunpharma.com/en/product/medical-list.aspx?type=8
Device identification number
4055
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Pathogens detected
SARS-CoV-2
Type of Antigen (in case of Antigen-based)
Nucleocapsid protein
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.1 (Kappa), B.1.617.2 (Delta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-09-20 01:49:58 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
Yes
Reader Required
No
Subcategory
Extraction kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
Detection Principle
Colloidal gold
LOD
31.3 TCID50/ml
Calibration
Not evaluated
Analytical Sensitivity
96.75 %
Analytical Specificity
98.26 %
Analysis of cross reactivity
Evaluated
False positives
1.7 %
False negatives
3.3 %
Precision
Evaluated
Accuracy
97.91 %
Robustness
Evaluated
Clinical Sensitivity
96.75 %
Clinical Specificity
98.26 %
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