ENCODE SARS-COV-2 Antigen rapid Test Device
Manufactured by Zhuhai Encode Medical Engineering Co.,Ltd, China - http//www.encode.com.cn
Device identification number
2587
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Cassette
Target
Antigen
Specimen
Anterior nasal swab, Nasal swab, Throat swab
Pathogens detected
SARS-CoV
Lineages detected
Commercial Status
Commercialised
Last Update
2021-08-30 01:28:36 CET
Comments
We added some information of our product
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Other
Method
Immunochromatography
Measurement
Qualitative
Time
20 minutes
Subclass
Sandwich
LOD
530 TCID50/ml
Calibration
Evaluated
Crossreactivity
Evaluated
Precision
Evaluated
Accuracy
98.37 % (Throat swabs)
Accuracy
97.55 % (Anterior nasal swabs)
Accuracy
98.37 % (Nasal swabs)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.49 % (Throat swabs)
Clinical Sensitivity
96.49 % (Nasal swabs)
Clinical Sensitivity
94.74 % (Anterior nasal swabs)
Clinical Specificity
100 % (Throat swabs)
Clinical Specificity
100 % (Nasal swabs)
Clinical Specificity
100 % (Anterior nasal swabs)
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