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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



RIDA®QUICK SARS-CoV-2 Antigen

Manufactured by R-Biopharm AG, Germany - www.r-biopharm.com 

Device identification number
2214
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Dipstick
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Nasal swab, Nasopharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
Der verwendete polyklonale Antikörper ist gegen das Nukleocapsidprotein gerichtet und insofern von den meisten Mutationen, die im Spikeprotein statfinden, nicht beeinflusst.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Sample preparation
Method
Immunochromatography
Measurement
Qualitative
Time
30 minutes
Subclass
Membrane-based
LOD
237 AU
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
bei hohen Konzentrationen an S.aureus (> 5 Mio Keime/ml)
Fn
bei Antigenkonzentrationen unterhalb 237 TCID50/ml
Precision
Evaluated
Accuracy
95 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93 %
Clinical Specificity
97 %
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