BIOCREDIT COVID-19 Ag Test Nasal
Manufactured by RapiGEN Inc, South Korea - rapigen-inc.com
Device identification number
1963
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target
Antigen
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2021-05-10 01:18:20 CET
Comments
As optional content, external controls swabs can be provided as a means on additional quality control to demonstrate a positive or negative reaction.
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Membrane-based
LOD
267 AU
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
0.95 % (2/211 (RT PCR))
Fn
6.94 % (5/72 (RT PCR))
Precision
Evaluated
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93 %
Clinical Specificity
99 %
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