COVID-19 Antigen Rapid Test Device; SARS-CoV-2 (N)protein Antigen rapid test (Fluorescence Immunochromatics assay)
Manufactured by LOMINA AG, Switzerland - www.lomina.ch/
Device identification number
678
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Oropharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
Yes
Subcategory
N.A.
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
LOD
100 ng/mL
Calibration
Evaluated
Accuracy
96.63 %
Clinical Sensitivity
94.55 %
Clinical Specificity
99.9 %
Type of antigen
SARS-CoV-2 Nucleocapsid Protein Antigen
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