SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography)
Manufactured by Beijing Lepu Medical Technology Co. Ltd., China - https://www.lepumedical.com/
Device identification number
1331
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Near POC / POC
Physical Support
Card
Target type
Antigen
Specimen
Nasal swab, Nasopharyngeal 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
Colloidal gold
Clinical Sensitivity
95.06 %
Clinical Specificity
99.62 %
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