SARS-CoV-2 Antigen Rapid Test Kit (Anterior Nasal
Manufactured by Zhejiang Anji Saianfu Biotech Co. Ltd., China - www.reopentest.com
Device identification number
1841
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette
Target type
Antigen
Specimen
Anterior nasal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
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Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
LOD
5.8 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
1.8 %
False negatives
0.9 %
Precision
Evaluated
Accuracy
98.8 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.2 %
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