Fosun Covid-19 Ag CARD
Manufactured by Fosun Diagnostics (Shanghai) Co. Ltd., China - https://www.fosunpharma.com/en/product/medical-list.aspx?type=8
Device identification number
2724
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
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
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.1.525 (Eta), B.1.526 (Iota), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.621 (Mu), C.37 (Lambda), P.1 (Gamma), P.2 (Zeta)
Commercial Status
Commercialised
Last Update
2022-11-17 10:12:18 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
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