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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Rapid Test SARS-CoV-2 Ag

Manufactured by AMEDA Labordiagnostik GmbH, Austria - www.amp-med.com/ 

Device identification number
1602
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2021-05-10 01:18:20 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
LOD
115 TCID50/ml
Crossreactivity
no cross reaction with RSV type A, RSV type B, novel influenza A H1N1,, Influenza A H3N2, Influenza A H5N1, Influenza B yamagata, Influenza B Victoria, Rhinovirus, Adenovirus 3, Adenovirus 7, EV-A71, Mycobacterium tuberculosis, Micoplasma pneumoniae, Mum
Fp
2.7 % (3 of 111)
Fn
0 % 0 of 139
Accuracy
98.8 %
Clinical Sensitivity
97.3 %
Clinical Specificity
100 %
Type of antigen
nucleocapside protein
Notes
Rapid diagnostic test cassette colloidal gold

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