COVID-19 Sero NP/RBD
Manufactured by Coris BioConcept, Belgium - www.corisbio.com
Device identification number
2002
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antibody
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Assay evaluated with Anti-SARS-CoV-Verification Panel for Serology Assays (NIBSC code: 20/B770): 100% Accuracy. Test identifies antibodies against Nucleoprotein (NP Line) and against RBD domain of the spike protein (RBD line).
Assay Type
Immuno-Antibody
Reader Required
No
Method
Immunochromatography
Time
15 minutes
LOD
10 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0 % No false positivity with seasonal coronaviruses HCoV-HKU1, -NL63, -OC43, and -229E
False negatives
1.47 % ((4 on 271 samples))
Precision
Not evaluated
Accuracy
98.5 %
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
98.4 % ((combined NP and RBD))
Clinical Specificity
98.5 %
Type of antigen
Other
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