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 (RAT)
×No
Format
Lab-based, Manual
Physical Support
Cassette, Lateral flow, Strip
Target type
Antigen
Specimen
Anterior nasal swab, Deep (cough) sputum, Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
A.23.1, B.1.1.7 (Alpha), B.1.351 (Beta), B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 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
Analysis of cross reactivity
Evaluated
False positives
0.87 % (2 False positives in 230 negative specimen)
False negatives
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