AndLucky SARS-CoV-2 Antigen SPUTUM Rapid Test Kit (non-invasive)
Manufactured by Zhejiang Anji Saianfu Biotech Co. Ltd., China - www.reopentest.com
Device identification number
1843
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Oropharyngeal swab, Sputum, Throat secretion, Throat swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
BfArM Listed, PEI Evaluated
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
LOD
6 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
6.5 % (93,5)
False negatives
0.6 % (99,40)
Precision
Evaluated
Accuracy
97 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93 %
Clinical Specificity
99 %
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