COVID-19 Antigen Nasal Test Kit
Manufactured by Assure Tech (Hangzhou) Co. Ltd., China - www.diareagent.com
Device identification number
2933
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
CE1434 certification has been completed
Assay Type
Immuno-Antigen
Self Test
Yes
Method
Immunoassay
Time
15 minutes
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
4.1 % (8 out of 195)
False negatives
0.24 % (1 out of 412)
Precision
Evaluated
Accuracy
98.5 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.1 %
Clinical Specificity
99.8 %
Type of antigen
Nucleocapsid protein
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