AndLucky SARS CoV-2 Antigen Rapid Test, Anterior Nasal Check (minimal-invasiv)
Manufactured by Zhejiang Anji Saianfu Biotech Co. Ltd., China - www.reopentest.com
Device identification number
2008
CE Marking
×No
HSC common list (RAT)
×No
Format
Automated, Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Specimen
Anterior nasal swab, Nasal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The detection limit of the coronavirus antigen rapid test is 5.75x10^2TCID50/m
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
LOD
5.75 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
2 AU
False negatives
4 AU
Precision
Evaluated
Accuracy
98.47 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.52 %
Clinical Specificity
99.13 %
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