Immunobio SARS-CoV-2 Antigen ANTERIOR NASAL Rapid Test Kit (minimal invasive)
Manufactured by Hangzhou Immuno Biotech Co. Ltd., China - www.immuno-test.com
Device identification number
1844
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
BfArM Listed, PEI evaluated
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
LOD
6 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
5.61 % (94,39)
False negatives
0 % 100
Precision
Evaluated
Accuracy
97.67 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
94 %
Clinical Specificity
100 %
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