SARS-Cov-2&Influenza A&B Combo Rapid Test Cassette (swab)
Manufactured by Hangzhou Realy Tech Co. Ltd., China - www.realytech.com
Device identification number
1789
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Specimen
Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Sample collection device
Method
Immunochromatography
Measurement
Qualitative
Time
20 minutes
Detection Principle
Colorimetry
LOD
0 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
3.83 %
Precision
Evaluated
Accuracy
98.79 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.17 %
Clinical Specificity
99.9 %
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