2019-nCoV Antigen Rapid Test (Immunochromatography Assay)
Manufactured by Shenzhen Superbio Technology Co. Ltd., China - http://sup-bio.com/
Device identification number
3086
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Anterior nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus 3, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Cytomegalovirus (CMV), Epstein-Barr Virus (EBV), Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B Victoria, Influenza B Yamagata, Mumps Virus (MuV), Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Respiratory Syncytial V (RSV), Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus
Pathogens detected
SARS-CoV-2
Type of Antigen (in case of Antigen-based)
Nucleocapsid protein
Lineages detected
B.1.1.529 (Omicron), B.1.617.2 (Delta)
Commercial Status
Commercialised
Last Update
2023-01-09 10:10:55 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
N.A.
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
Detection Principle
Other (Latex immunochromatography technology)
Accuracy
98.5 % (Anterior nasal site1)
Accuracy
97.5 % (Nasopharyngeal site1)
Accuracy
97.1 % (Oropharyngeal site1)
Accuracy
97.7 % (Anterior nasal site2)
Clinical Sensitivity
96.5 % (Anterior nasal site1)
Clinical Sensitivity
93.8 % (Nasopharyngeal site1)
Clinical Sensitivity
93.8 % (Oropharyngeal site1)
Clinical Sensitivity
92.4 % (Anterior nasal site2)
Clinical Specificity
99.7 % (Anterior nasal site1)
Clinical Specificity
99.9 % (Nasopharyngeal site1)
Clinical Specificity
99.4 % (Oropharyngeal site1)
Clinical Specificity
99.9 % (Anterior nasal site2)
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