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) - Nasal Swab

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

Device identification number
1815
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Near POC / POC
Physical Support
Lateral flow
Target
Antigen
Specimen
Anterior nasal swab, Nasal swab
Commercial Status
Commercialised
Last Update
2021-07-07 05:18:58 CET
Comments
Please check attached UK national systematic evaluation report with the detailed data from UK government validation, performed by University of Oxford. Public Health England Porton Down. 132 brands were tested and only 4 suppliers have passed all of the Phase 3B validation, including ANHUI DEEPBLUE MEDICAL. The link of this report: https://www.medrxiv.org/content/10.1101/2021.01.13.21249563v1.full-text Please check attached UK national systematic evaluation report with the detailed data from UK government validation, performed by University of Oxford. Public Health England Porton Down. 132 brands were tested and only 4 suppliers have passed all of the Phase 3B validation, including ANHUI DEEPBLUE MEDICAL. The link of this report: https://www.medrxiv.org/content/10.1101/2021.01.13.21249563v1.full-text And we have attached the MHRA registration certificate. Also the registration in Germany, registration in Italy, registration in Portugal and so on.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
20 minutes
Detection Principle
Colorimetry
LOD
320 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0.2 %
Fn
3.6 %
Precision
Evaluated
Accuracy
99.03 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.4 %
Clinical Specificity
99.8 %
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