Covid-19 Ag K-SeT
Manufactured by Coris BioConcept, Belgium - www.corisbio.com
Device identification number
2648
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.526.2, B.1.617.2 (Delta), P.1 (Gamma), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
New clinical validation on 174 samples (36 positives and 138 negatives versus PCR. 1 false negative observed.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Capture
LOD
140 TCID50/ml
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
1 % (New clinical validation on 174 samples (36 positives and 138 negatives versus PCR. 1 false negative observed)
Precision
Evaluated
Accuracy
99.4 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.2 %
Clinical Specificity
100 %
Type of antigen
Nucleocapsid protein
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