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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Novel Coronavirus (SARS-CoV-2) Antigen Detection Kit(Colloidal Gold)

Manufactured by Avioq Bio-Tech Co., Ltd, China - www.avioqbio.com 

Device identification number
1972
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual
Physical Support
Cassette
Target
Antigen
Specimen
Anterior nasal swab, Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2021-09-03 01:56:26 CET
Comments
No
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Other
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
Detection Principle
Colloidal gold
LOD
100 (pg/mL)
Crossreactivity
Evaluated
Fp
0 %
Fn
5.75 % ((5/47))
Precision
Evaluated
Accuracy
97.13 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
94.25 %
Clinical Specificity
100 %
Type of antigen
Nucleocapsid protein

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