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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

NOVA Test® SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography)

Manufactured by Atlas Link Technology Co., Ltd., China - http://www.atlas-link.com/english/ 

Device identification number
2010
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow, Strip
Target
Antigen
Specimen
Nasal swab, Oropharyngeal swab
Commercial Status
Commercialised
Last Update
2021-07-07 05:19:54 CET
Comments
Our NOVA Test® SARS-CoV-2 Antigen Rapid Test Kit has been posted on the antigen list of German BfArM, it has also been on the PEI list.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
Detection Principle
Colloidal gold
LOD
50 AU
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
0.6 %
Fn
1.5 %
Precision
Not evaluated
Accuracy
99.1 %
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
98.5 %
Clinical Specificity
99.4 %
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