SARS-CoV-2 Antigen Rapid Test Cassette
Manufactured by Hangzhou Sejoy Electronics & Instruments Co. Ltd., China - sejoy.com/
Device identification number
2671
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
Adenovirus 3, Bordetella Pertussis, Epstein-Barr Virus (EBV), Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza A H3N2, Influenza B Victoria, Mycoplasma Pneumoniae, Parainfluenza Virus Type 2, Respiratory Syncytial V (RSV)
Pathogens detected
SARS-CoV-2
Type of Antigen (in case of Antigen-based)
Nucleocapsid protein
Lineages detected
B.1.1.7 (Alpha)
Commercial Status
Commercialised
Last Update
2023-03-02 11:30:05 CET
Comments
We have also evaluated interference substance as following:Whole Blood,Ibuprofen,Tetracycline,Mucin,Erythromycin,Tobramycin,Menthol,Afrin, Compound Benzoin Gel,Cromolyn glycate , Chloramphenicol ,Mupirocin,Oseltamivir,Naphazoline Hydrochlo-ride Nasal Drops,Fluticasone propionate spray,Deoxyepinephrine hydro-chloride
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
N.A.
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Sandwich
Detection Principle
Other (immunoassay)
LOD
400 TCID50/ml
Calibration
Not evaluated
Analytical Sensitivity
87 %
Analytical Specificity
100 %
Analysis of cross reactivity
Evaluated
False positives
%
False negatives
13 %
Precision
Evaluated
Accuracy
97.79 %
Robustness
Evaluated
Clinical Sensitivity
87 %
Clinical Specificity
100 %
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