Seinofy COVID-19 Antigen Rapid Test
Manufactured by Zhejiang Anji Saianfu Biotech Co.,Ltd., China - http://www.seinofy.com
Device identification number
2223
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Lab-based, Manual
Physical Support
Cassette, Lateral flow, Strip
Target
Antigen
Specimen
Anterior nasal swab, Deep (cough) sputum, Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Other
Pathogens detected
SARS-CoV
Lineages detected
Commercial Status
Commercialised
Last Update
2021-06-10 05:25:42 CET
Comments
more information please check with sales@seinofy.com
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
LOD
AU 580
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0.87 % (2 False positives in 230 negative specimen)
Fn
2.48 % (4 False negative in 161 positives specimen)
Precision
Evaluated
Accuracy
98.47 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.5 %
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