SARS-CoV-2 Antigen Rapid Test Kit
Manufactured by Beijing Lepu Medical Technology Co., Ltd - https://en.lepumedical.com/
Device identification number
1331
CE Marking
✓Yes
HSC common list
✓Yes
HSC mutual recognition
✓Yes
Format
Near POC / POC
Physical Support
Card
Target
Antigen
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
03/26/2021 02:15
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
Accuracy
96.67 %
Clinical Sensitivity
92 %
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