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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



ScheBo SARS CoV-2 Quick Antigen

Manufactured by ScheBo Biotech AG, Germany - www.schebo.de/ 

Device identification number
1201
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Nasopharyngeal swab, Oropharyngeal swab, Serum
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Fluorescence
LOD
3.5 U/ml
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
1.12 % (6/534)
Fn
3.44 % (4/116)
Precision
Evaluated
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.77 %
Clinical Sensitivity
96.6 % (Ct 30)
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