GENEDIA W COVID-19 Ag (643K)
Manufactured by GC Medical Science Corp., South Korea
Device identification number
3190
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Anterior nasal swab
Cross-reactivity (pathogens tested)
Adenovirus, Adenovirus 3, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Enterovirus A71 (EV-A71), Hemophilus Influenzae, Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza B, Influenza B Victoria, Influenza B Yamagata, Mycoplasma Pneumoniae, Parainfluenza Virus Type, 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
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-10-05 02:00:03 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Visualisation system
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Membrane-based
Detection Principle
Chemiluminescence
LOD
750 TCID50/ml
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
6.25 % (4 of the total 64 positive specimens compared to RT-PCR Ct interval ≤ 25, in All Population)
False negatives
0 % 0 of the total 400 negative specimens.compared to RT-PCR Ct interval ≤ 25, in All Population
Precision
Evaluated
Accuracy
100 %
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
93.75 %
Clinical Specificity
100 %
Type of antigen
Nucleocapside 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