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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

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
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
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
2022-08-24 09:08:01 CET
Comments
Fosun Covid-19 Ag CARD is BfArM listed and by PEI evaluated.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Extraction kit
Method
Immunoassay
Measurement
Qualitative
Time
5 minutes
Subclass
Sandwich, Double
LOD
31.3 TCID50/ml
LOD
31.3 TCID 50 /mL
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
2.3 %
False negatives
1.3 %
Precision
Evaluated
Accuracy
98.4 % (Antigen)
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
97.7 % (Antigen)
Clinical Specificity
98.7 % (Antigen)
Type of antigen
Nucleocapsid protein

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