COVID-19 Antigen Test Kit (Dry Fluorescence Immunoassay)
Manufactured by Lansion Biotechnology Co., Ltd., China - www.lansionbio.com/
Device identification number
1648
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Strip
Target
Antigen
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
Yes
Method
Immunoassay
Measurement
Quantitative
Time
15 minutes
Subclass
Fluorescence
LOD
0 AU
Calibration
evaluated
Crossreactivity
evaluated
Fp
3 %
Fn
2 %
Precision
evaluated
Accuracy
98 %
Reproducibility
evaluated
Robustness
evaluated
Clinical Sensitivity
95 %
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