2019-nCoV Antigen Rapid Test Kit (Colloidal Gold Immunochromatography)
Manufactured by Beijing Lepu Medical Technology Co. Ltd., China - https://www.lepumedical.com/
Device identification number
1790
CE Marking
✓Yes
HSC common list (RAT)
×No
Physical Support
Card
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
LOD
200 IU/ml
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0.38 %
False negatives
4.94 %
Precision
Evaluated
Precision
Evaluated
Accuracy
97.44 %
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
95.06 %
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