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, C.37 (Lambda), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
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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
530 AU
LOD
530TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
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