Fosun Covid-19 Ag CARD
Manufactured by Shanghai Fosun Long March Medical Science Co. Ltd., China - en.lm-diagnostics.com.cn/
Device identification number
2894
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Anterior nasal swab, Nasopharyngeal swab, Oropharyngeal swab
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
Method
Immunoassay
Time
15 minutes
LOD
31.3 TCID50/ml ( TCID 50 /mL)
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0.5 % (99.5%)
False negatives
3.9 % (96.1%)
Precision
Not evaluated
Accuracy
98.3 % (Antigen)
Reproducibility
Not evaluated
Robustness
Not evaluated
Clinical Sensitivity
96.1 % (Antigen)
Clinical Specificity
99.5 % (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