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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Acura Speichel-Test Diagnos COVID-19 Antigen Saliva Test Kit

Manufactured by Acura Kliniken Baden-Baden GmbH, Germany - https://acura-kliniken.com/ 

Device identification number
2459
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual
Physical Support
Cassette, Lateral flow
Target type
Antibody, Antigen
Targets
nucleocapsid protein,
Specimen
Deep (cough) sputum, Oropharyngeal swab, Other biological fluids, Saliva
Pathogens detected
SARS-CoV
Commercial Status
Commercialised
Last Update
2021-08-10 01:52:05 CET
Comments
Pleas contact B.Grunberg: B.Grunberg@acura-kliniken.com
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Sample collection device
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
Detection Principle
Colloidal gold
LOD
0 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0 %
Fn
0 %
Precision
Evaluated
Accuracy
98.2 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.1 %
Clinical Specificity
99.33 %
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