biocomma®COVID-19 Antigen Test Kit
Manufactured by Biocomma limited, China - www.biocomma.com
Device identification number
1687
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Target
Antigen
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
Yes
Method
Chromatography
Measurement
Qualitative
Time
15 minutes
LOD
312.5 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0.55 %
Fn
17.9 %
Precision
Evaluated
Accuracy
97.13 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
82.14 %
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