COVID-19 Ag+Flu A/Flu B Rapid Test (Immunochromatography Assay)
Manufactured by Shenzhen Superbio Technology Co. Ltd., China - http://superbiodx.com/
Device identification number
3617
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
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 OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Epstein-Barr Virus (EBV), Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza A H3N2, Influenza B Victoria, Influenza B Yamagata, Mumps Virus (MuV), Mycoplasma Pneumoniae, Other (Staphylococcus aureus, Streptococcus pyogenes, Measles Virus, Streptococcus pneumoniae, Candida albicans, Legionella pneumophila, Staphylococcus epidermidis, Adenovirus Type 5), Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Rhinovirus
Pathogens detected
Influenza A H1N1, Influenza A H3N2, Influenza B Victoria, Influenza B Yamagata
Type of Antigen (in case of Antigen-based)
Nucleocapsid protein
Lineages detected
B.1.1.529 (Omicron), B.1.351 (Beta), B.1.617.2 (Delta), B.1.617.3, Other (Mutant B.1.2, Mutant B.1.1.28)
Commercial Status
Commercialised
Last Update
2022-11-21 09:02:27 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Other (Screening Kit)
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
Detection Principle
Not found
LOD
80 TCID50/ml
Clinical Sensitivity
96 % (For SARS-CoV-2 (A separate data analysis has been done for special strains, which are not included in the overall data statistics))
Clinical Sensitivity
93.6 % (For Influ A)
Clinical Sensitivity
90.7 % (For Influ B)
Clinical Specificity
99.9 % (For SARS-CoV-2 (A separate data analysis has been done for special strains, which are not included in the overall data statistics))
Clinical Specificity
99.9 % (For Influ A)
Clinical Specificity
99.9 % (For Influ B)
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