FREND COVID-19 Ag
Manufactured by NanoEntek, South Korea - www.nanoentek.com
Device identification number
1420
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Automated
Physical Support
Cartridge
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus 3, Adenovirus 7, Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza B, MERS-CoV, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus, Rhinovirus A, Rhinovirus B
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), P.2 (Zeta)
Commercial Status
Commercialised
Last Update
2022-12-12 04:52:17 CET
Comments
-
Assay Type
Immuno-Antigen
Reader Required
Yes
Subcategory
Other ()
Method
Immunoassay
Measurement
Quantitative
Time
3 minutes
LOD
147 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
%
False negatives
5.9 %
Precision
Evaluated
Accuracy
97.06 % ( (antigen))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
94.12 %
Clinical Sensitivity
94.12 %
Clinical Specificity
100 %
Clinical Specificity
100 %
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