(2019-nCoV) New coronavirus Antibody Test (Colloidal Gold)
Manufactured by Nantong Diagnos Biotechnology Co., Ltd, China - www.diagnosbio.com
Device identification number
1355
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Cassette
Target
Antibody, IgG, IgM
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2021-05-10 01:18:20 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
LOD
0 AU
Analytical Sensitivity
87.04 % IgG
Accuracy
93.33 % IgM
Accuracy
92.38 % IgG
Clinical Sensitivity
88.89 % IgM
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