Skip to main content
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



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
1902
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Anterior nasal swab, Nasal swab, Throat swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
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), C.37 (Lambda),
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
We add some information of our product. Thank you very much.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Other
Method
Immunochromatography
Measurement
Qualitative
Time
20 minutes
Subclass
Sandwich
Detection Principle
Colorimetry
LOD
530TCID50/ml
LOD
530 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0 %
Fn
4 AU
Precision
Evaluated
Accuracy
98.37 % (Nasal swabs)
Accuracy
97.55 % (Anterior nasal swabs)
Accuracy
98.37 (Throat swabs)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
94.74 % (Anterior nasal swabs)
Clinical Sensitivity
96.49 % (Nasal swabs)
Clinical Sensitivity
96.49 (Throat 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