SARS-CoV-2 Antigen Rapid Test Cassette (nasal, nasopharyngeal, oropharyngeal, saliva)
Manufactured by Hangzhou Sejoy Electronics & Instruments Co. Ltd., China - sejoy.com/
Device identification number
1952
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
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Saliva
Cross-reactivity (pathogens tested)
Other (HCOV-HKU1 Group A streptococci Measles virus Mumps virus Adenovirus type 3 Mycoplasmal pneumonia Paraimfluenzavirus,type2 Human metapneumovirus Human coronavirus OC43 Human coronavirus 229E Bordetella parapertusis Influenza B Victoria STRAIN )
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
2023-02-23 06:20:31 CET
Comments
We have also evulated the interference substance.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Other ()
Method
Immunochromatography
Measurement
Qualitative
Time
20 minutes
Subclass
Sandwich
Detection Principle
Immunofluorescence
LOD
400 AU
Calibration
Not evaluated
Analytical Sensitivity
97.4 %
Analytical Specificity
99.1 %
Analysis of cross reactivity
Evaluated
False positives
2 tests (2(Nasal swab),3(Oropharyngeal swabs),2(Nasopharyngeal swabs),3(Saliva))
False negatives
3 tests (3(Nasal swab),5(Oropharyngeal swabs),3(Nasopharyngeal swabs),5(Saliva))
Precision
Evaluated
Accuracy
98.5 % (98.48%(Nasal swab),98.67%(Oropharyngeal swabs),98.48%(Nasopharyngeal swabs),98.46%(Saliva))
Robustness
Evaluated
Clinical Sensitivity
97.4 % (97.4%(Nasal swab),95.76%(Oropharyngeal swabs),97.4%(Nasopharyngeal swabs),95.65%(Saliva))
Clinical Specificity
99.1 % (99.1%(Nasal swab),99.38%(Oropharyngeal swabs),99.1%(Nasopharyngeal swabs),99.26%(Saliva))
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