COVID-19 (SARS-CoV-2) Antigen Test Kit(Colloidal Gold)
Manufactured by ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD. - www.dbluemedical.com,
Device identification number
1736
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Target
Antigen
Specimen
Nasal swab, Other
Commercial Status
Commercialised
Last Update
03/25/2021 05:41
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
20 minutes
Detection Principle
Colorimetry
LOD
320
Calibration
not evaluated
Crossreactivity
evaluated
Fp
2.27 % 5 of 220
Fn
0.9 % 2 of 220
Precision
evaluated
Accuracy
98
Reproducibility
evaluated
Robustness
not evaluated
Clinical Sensitivity
95.7
Type of antigen
nucleoprotein
Notes
rapid diagnostic test cassette colloidal gold
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