Rapid SARS-CoV-2 Antigen Test Card
Manufactured by MP Biomedicals, Germany - https://www.mpbio.com/eu/
Device identification number
1481
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Anterior nasal swab, Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
We would like it to beupdated that the company is MP Biomedicals Germany GmbH and also refer to the EU website that is in this update. What is currently online directs people to the USA company.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
LOD
1 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
Precision
Evaluated
Accuracy
98.25 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.17 %
Clinical Specificity
99.16 %
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