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 (RAT)
×No
Format
Near POC / POC
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 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
Analysis of cross reactivity
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
False positives
2.7 % (3 of 111)
False negatives
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