Skip to main content
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 (Sars-CoV-2) Antigen Test Kit (Colloidal Gold)

Manufactured by Anhui Deep Blue Medical Technology Co., Ltd, China - www.dbluemedical.com 

Device identification number
1589
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Nasal swab, Saliva
Commercial Status
Commercialised
Last Update
2021-05-10 01:18:20 CET
Comments
website not accessible (considered suspicious for the EC)
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
20 minutes
Detection Principle
Colorimetry
LOD
320 AU
Calibration
evaluated
Crossreactivity
evaluated
Fp
0
Fn
3.6
Precision
evaluated
Accuracy
99.03 %
Reproducibility
evaluated
Robustness
evaluated
Clinical Sensitivity
96.4 %
Type of antigen
nucleoprotein
Notes
Rapid diagnostic test cassette

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