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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

2019-nCoV Antigen Rapid Test Kit (Colloidal Gold Immunochromatography)

Manufactured by Beijing Lepu Medical Technology Co., Ltd, China - en.lepumedical.com/ 

Device identification number
1790
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Other
Physical Support
Card
Target
Antigen
Specimen
Nasal swab, Other
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 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
Crossreactivity
Evaluated
Fp
0.38 %
Fn
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