COVID-19 (Sars-CoV-2) Antigen Test Kit (Colloidal Gold) - (Nasal swab/saliva)
Manufactured by Anhui Deep Blue Medical Technology Co. Ltd., China - www.dbluemedical.com
Device identification number
1589
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab, Saliva
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 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
Analysis of cross reactivity
Evaluated
False positives
0
False negatives
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