SARS-CoV-2 & Influenza A+B Antigen Combo Rapid Test Cassette
Manufactured by Hangzhou Sejoy Electronics & Instruments Co. Ltd., China - sejoy.com/
Device identification number
2063
CE Marking
✓Yes
HSC common list (RAT)
✓Yes
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
Influenza A, Influenza B, SARS-CoV
Lineages detected
P.2 (Zeta)
Commercial Status
Commercialised
Last Update
2022-10-05 02:06:10 CET
Comments
We have also evaluated the interference substances.
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Other ()
Method
Immunoassay
Measurement
Qualitative
Time
20 minutes
Subclass
Sandwich
LOD
40050 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
2 AU
False negatives
3 AU
Precision
Evaluated
Accuracy
98.5 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.4 %
Clinical Specificity
99.1 %
Type of antigen
Nucleoprotein
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